Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

22nd Annual 

E UROM EETING 

Monaco 2010 

ADVANCE PROGRAMME 

• Neutral, global forum for more than 3,000 

professionals involved in the development of 

medicines from over 50 countries 

• Speakers from the EMEA, the European 

Commission, the FDA and other regulatory 

agencies throughout Europe 

• More than 240 exhibitors on one of the largest 

exhibition floors in Europe 

• Unparalleled multi-disciplinary networking 

opportunities 

• Student and professional poster sessions 

• Active involvement by patient organisations 

• Pre-conference tutorials led by expert faculty 

• Over 110 sessions 

• Hot topic sessions 

March 8-10, 2010 

Grimaldi Forum 

Monaco

Disclosure Policy 

It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the programme audience (1) any real or 

apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabelled or unapproved uses of drugs or medical devices. Faculty 

disclosures will be included in the course materials. 

Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they 

represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop 

information in any type of media, is prohibited without prior written consent from DIA. 

2 

Table of Contents 

This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 

Disclosure Policy............................................................................................................................................................................................................................................. 2 

Welcome from the EuroMeeting 2009 Co-Chairs................................................................................................................................................................................ 3 

Programme Advisors..................................................................................................................................................................................................................................... 3 

Theme Leaders............................................................................................................................................................................................................................................... 4 

Plan Your EuroMeeting Experience.......................................................................................................................................................................................................... 5 

Opening Plenary Session..............................................................................................................................................................................................................................6 

Student and Young Professionsal Session..............................................................................................................................................................................................7 

Agency Satellite Session..............................................................................................................................................................................................................................7 

Japanese Regulatory Session....................................................................................................................................................................................................................7 

Session Topics in Specific Interest Areas...........................................................................................................................................................................................8-9 

EuroMeeting Special Programmes.........................................................................................................................................................................................................10 

Pre-Conference Tutorials......................................................................................................................................................................................................................11-16 

Greening the EuroMeeting.......................................................................................................................................................................................................................17 

Accreditation and Credit Designation.................................................................................................................................................................................................16 

Sessions: Theme 1-14..........................................................................................................................................................................................................................18-40 

Hot Topics and Stand-Alone Sessions.........................................................................................................................................................................................40-44 

Exhibitors...................................................................................................................................................................................................................................................46 

About Monaco..........................................................................................................................................................................................................................................47 

Accommodation in Monaco ................................................................................................................................................................................................................48 

Monaco Tours...........................................................................................................................................................................................................................................49 

Networking Opportunities...................................................................................................................................................................................................................50 

Discounted and Complimentary Transportation Offers............................................................................................................................................................. 51 

EuroMeeting at a Glance...............................................................................................................................................................................................................52-54 

Key Contacts...........................................................................................................................................................................................................................................53 

Registration Form.................................................................................................................................................................................................................................54

Welcome from the EuroMeeting 2010 Co-Chairs 

Bruno Flamion and Kerstin Franzén 

Dear Colleague, 

It is our pleasure to invite you to participate in the 22nd Annual 

EuroMeeting in Monaco, 8-10 March 2010. Three days of discussion, 

sharing of experience, debating and networking will show the vitality of 

drug development in Europe and across the world. Whether you are a 

session chair, speaker, tutorial instructor or attendee, and whether you 

are from a regulatory agency, academia, industry or a patient group, or 

a student or young professional, we believe you can play a key role in 

building the success of the EuroMeeting and ensuring its place as one of 

the most important European conferences for professionals involved in the 

development of medicines. 

When deciding on the themes, we have chosen the integrated, multi-disciplinary 

approach. The aim is to generate interest from as many disciplines as possible and 

to create a lively platform for a debate on development but also market access of 

medicines in Europe. We are aware that many of you will be looking for your 

specific area of interest in the programme such as non-clinical aspects, 

statistics, IT, etc. The Session Finder on pages 8-9 will highlight which 

sessions will discuss these aspects. We trust that you will build your own 

theme. Why not take this opportunity to look across the board and find 

exciting cross-disciplinary topics? 

Monaco is an exciting location, well-known to most people. Despite 

being a small country, it has a lot to offer and is very hospitable and 

culturally interesting. No doubt there are numerous challenges around 

but we strongly believe you should not miss this opportunity to bring 

your contribution to the debate on drug development. Make your plans 

to come to Monaco in March 2010! 

Bruno Flamion and Kerstin Franzén 

Programme Advisors 

Melek Bostanci Onol, DRA Manager, Boehringer 

Ingelheim Ilac Ticaret A.S., Turkey 

Daniel Brasseur, Chair PDCO, Senior Member, 

Federal Drug Agency, Belgium 

Emmanuel Chantelot, Executive Director, European 

Biopharmaceutical Enterprises (EBE), Belgium 

Daan Crommelin, Scientific Director, Top Institute 

Pharma, The Netherlands 

Anne de Bock, Portfolio Leader Oncology & Antiinfectives, 

AstraZeneca, Belgium 

Hans-Georg Eichler, Senior Medical Officer, 

European Medicines Agency, EU 

Julianne Hull, Senior Director, Global Development 

Data Operations, Wyeth Research, UK 

Robert Hemmings, Statistics Unit Manager, MHRA, 

UK 

Sabina Hoekstra-van den Bosch, Senior Advisor, 

Department of Pharmaceutical Affairs and Medical 

Technology, Ministry of Health, Welfare and Sport, 

The Netherlands 

Tim Kievits, CEO, PamGene, Chair of EuropaBio 

Personalised Medicines Working Group, 


Ingrid Klingmann, Managing 

Director, Pharmaplex, Belgium 

Jytte Lyngvig, Chief Executive Officer, Danish 

Medicines Agency, Denmark 

José Ramet, Professor, University of Antwerp, 

Chairman, Paediatric Department, University 

Hospital Antwerp and Queen Paola Children’s 

Hospital, Belgium 

Andrea Rappagliosi, Vice President European 

Government Affairs & Head of Brussels Office, 

GlaxoSmithKline, UK 

Jean-Louis Robert, Head, Department of Medicines 

Control Laboratory, National Health Laboratory, 

Luxembourg 

Malcolm Rowland, Emeritus Professor, School of 

Pharmacy and Pharmaceutical Sciences University 

of Manchester, England 

Agnès Saint Raymond, Head of Human Medicines 

Special Areas, European Medicines Agency, EU 

Christian Schneider, Chair CAT, European Medicines 

Agency, Acting Head, Division EU 

Cooperation/Microbiology, Paul-Ehrlich-Institut, 

Germany 

Bruno Flamion 

Professor, Clinical Pharmacology, University of Namur, Belgium 

and Chair, CHMP, Scientific Advice Working Party, European 

Medicines Agency 

Bruno Flamion is an MD who practised internal medicine and nephrology in 

Belgium. He was a Research Fellow at the NIH (1988-1992) and with the 

Belgian National Fund for Scientific Research (1992-1996) and later got a PhD 

in physiological sciences from the University of Brussels. He is now Full 

Professor of Physiology and Pharmacology at the University of Namur, 

Belgium, where he heads a molecular physiology lab. He has been involved as 

a medical expert for the Belgian Federal Agency for Medicines and Health 

Products (FAMHP) since 1999 and for the European Medicines Agency: CHMP, 

PK group, Pharmacogenomics, and more recently CAT (Committee for 

Advanced Therapies). His favourite activity is chairing the Scientific Advice 

Working Party. 

Kerstin Franzén 

Senior Director, Regulatory Policy & Intelligence, 

Pfizer, Sweden 

Kerstin Franzén has a background in Regulatory Affairs covering 29 years. 

After an academic degree at Uppsala University, M Pharm Sci, she joined the 

pharmaceutical industry, first for a short period in the marketing area, and 

then went into the regulatory arena. The first seven years were spent with the 

Roche affiliate in Sweden, followed by a move to the Swiss headquarters 

where she stayed for four years, still in Regulatory Affairs. In 1990 she decided 

to join Kabi Pharmacia and go back to Sweden. This company went through 

a number of mergers and acquisitions, which eventually led to her current 

position with Pfizer in Regulatory Policy & Intelligence, an area she has been 

involved in since 1998. 

Beatriz Silva Lima, CHMP, European Medicines 

Agency, Professor, Pharmacology, University of 

Lisbon, INFARMED, Portugal 

Susie Stephens, Director of Biomedical Informatics, 

Johnson and Johnson Pharmaceutical R&D, UK 

Wolfgang Summa, Executive Vice President, 

Business Development, OmniComm Systems, 

Germany 

Erik Tambuyzer, Senior Vice President, Corporate 

Affairs, Europe and International, Genzyme, Belgium 

Catherine Tuleu, Senior Lecturer and Deputy 

Director, The School of Pharmacy, University of 

London, UK 

Noël Wathion, Head of Patient Health Protection, 


Paul Woods, Global Compliance Policy Director, 

AstraZeneca, UK 

3

4 

Theme Leaders 

Christelle Anquez-Traxler 

Regulatory and Scientific Affairs 

Manager, AESGP, Belgium 

Valdo Arnera 

General Manager, Europe, PHT 

Corporation, Switzerland 

Mary Baker 

President, European Federation of 

Neurological Associations, UK 

Patrick Celis 

Scientific Administrator, Scientific 

Committee Support, European 

Medicines Agency, EU 

Catarina Edfjäll 

Head of Regulatory Affairs Europe, 

Celgene International SARL, 

Switzerland 

Zaide Frias 

Head of Regulatory Affairs, European 


Trevor Gibbs 

Executive Vice President, ii4sm, 

Switzerland 

Wills Hughes-Wilson 

Senior Director, Health Policy Europe, 

Genzyme, Belgium 

About the DIA EuroMeeting 

Jackie Hunter 

Senior Vice President, Science 

Environment Development, 


Brenton James 

Consultant in Strategic Regulatory 

Affairs in the European Union, UK 

Angelika Joos 

Director, Regulatory Policy Europe, 

Merck Sharp & Dohme (Europe) Inc., 

Belgium 

Craig Johnson 

Principal Regulatory Scientist, 

Regulatory Information & External 

Affairs, Eli Lilly, UK 

Brigitte Keller-Stanislawski 

Head, Pharmacovigilance, Paul-Ehrlich- 

Institut, Germany 

Thomas Kühler 

Regulatory Affairs Specialist, Sweden 

Pierre-Yves Lastic 

Senior Director, Data Privacy & 

Healthcare Interoperability Standards, 

sanofi-aventis, France 

Hubert Leufkens 

Professor, Division of 

Pharmacoepidemiology and 

Pharmacotherapy, Utrecht Institute for 

Pharmaceutical Studies, 


Damian O’Connell 

Vice President Clinical R&D, Global 

Research and Development, Pfizer, Ltd., 

UK 

Marisa Papaluca-Amati 

Head of Scientific Support and Projects, 


Tomas Salmonson 

Vice Chair CHMP, European Medicines 

Agency, MPA, Sweden 

Gabriele Schwarz 

Head, GCP Inspection Services, BfArM, 

Germany 

Thomas Severin 

Medical Scientific Expert, Novartis 

Pharma AG, Switzerland 

Nick Sykes 

Director, Head, Global Regulatory 

Intelligence and TA Analysis, Pfizer, UK 

Geoff Tucker 

Emeritus Professor of Clinical 

Pharmacology, University of Sheffield, 

and Chairman of Simcyp Ltd., UK 

Beat Widler 

Global Head, Clinical Quality Assurance, 

F. Hoffmann-La Roche AG, Switzerland 

The Drug Information Association’s Annual EuroMeeting is global in scope, attracting well over 3,000 professionals from over 50 

countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, academic 

research centres, regulatory agencies and health ministries. This convergence affords attendees the opportunity to network 

with professional colleagues from around the world. 

The DIA is a professional association of approximately 18,000 members worldwide who are involved in the discovery, 

development, regulation, surveillance or marketing of pharmaceuticals or related products. We are committed to the 

broad dissemination of information on the development of new medicines or generics and biosimilars, with continuously 

improved professional practice as the goal. The DIA is a financially independent non-profit organisation that funds itself 

from meeting and membership fees. The voluntary efforts of DIA members and speakers allow the DIA to organise 

conferences, workshops and training courses and provide publications at a reasonable, competitive cost. 

Do you have a question about the EuroMeeting? Contact Dermot Ryan, Senior Event Manager (EuroMeeting): 

dermot.ryan@diaeurope.org or call +41 61 225 51 32 

Cover Image: Roger Broders, “La Corne d’Or Nice Villefranche Monaco” - © 2009 ProLitteris, Zurich

Plan Your 

EuroMeeting 

Experience! 

Sunday, March 7, 2010 

10:00-18:00 EuroMeeting Information Desk – Fairmont Hotel Lobby 

15:00-18:00 Conference Registration/Information Open at Grimaldi 

Forum. Avoid the rush on Monday by picking up your 

badge on Sunday afternoon. 

17:00-17:30 Student Poster Welcome: Students only 

17:30-18:00 Patient Fellowship Welcome: Patient representatives only 

Monday, March 8, 2010 

07:30-19:00 Conference Registration/Information Open 

09:00-12:30 Pre-Conference Tutorials – See page 11-16 

09:00-10:30 Student and Young Professional Session 1 – See page 7 

11:00-12:30 Student and Young Professional Session 2 – See page 7 

CONFERENCE OPENS 

12:30-14:00 Lunch 

12:45-13:45 Students/Young Professionals Networking Lunch 

12:30-18:00 Exhibition Open 

13:30-16:00 Opening Plenary Session – See page 6 

16:30-18:00 Session 1 - Choose from 14 parallel sessions! 

18:30-20:00 Mediterranean Networking Reception at the Fairmont 

Hotel 

Tuesday, March 9, 2010 

07:30-18:30 Conference Registration/Information Open 

08:00-09:00 Welcome Coffee 

08:00-18:30 Exhibition Open 

09:00-10:30 Session 2 - Choose from 15 parallel sessions! 

10:30-11:00 Coffee Break 

11:00-12:30 Session 3 - Choose from 15 parallel sessions! 

12:45-13:45 Patients’ Working Lunch: Skills Session 


• Knowledge 

• Networking 

• EuroMeeting Information 


12:30-13:15 DIA Special Interest Area Communities (SIACs) – 

Meet and Eat 

13:30-14:00 Speed Networking 


14:00-15:30 Student Session in partnership with EPSA and the IFMSA 



17:30-18:30 The Tuesday Reception on the Exhibition Floor 

18:00-19:30 Agency Satellite Session – See page 7 

19:30-20:30 DIA VIP Reception – Invitation only. Regulators, Patients, 

EuroMeeting Programme Committee, DIA Board of 

Directors, DIA Regional Advisory Councils and other 

invited guests 

Wednesday, March 10, 2010 

07:30-16:00 Conference Registration/Information Open 

08:00-14:00 Exhibition Open 

08:00-09:00 Welcome Coffee 

08:15-09:00 Patient Representative Breakfast Meeting – Patients only 

09:00-10:30 Session 6 - Choose from 14 parallel sessions! 

09:30-10:30 Student Roundtable 


11:00-12:30 Japanese Regulatory Session – See page 7 




CONFERENCE CLOSES 

5

6 

Opening 

Plenary 

The opening plenary session will be structured as an “Oxford Debate” following the University of Oxford’s eminent tradition. The motion, i.e., the topic, is 

drawn from the current, exceedingly challenging environment of the pharmaceutical business. The debate will be drawn from the current, exceedingly challenging 

environment of the pharmaceutical business. Details of the exact motion(s) are currently under development and will be made available closer to 

the time of EuroMeeting. 

Motion for debate: 

The process to develop new medicines and bring them to patients is neither efficient nor effective. There is a risk that medical needs will no longer be 

fulfilled in the future if the relevant stakeholders are not included in the process. 

For the motion: 

Richard Bergström, Director-General, Swedish Association of the Pharmaceutical Industry 

Eddie Gray, President, Pharmaceuticals Europe, GlaxoSmithKline 

Against the motion: 

Eric Abadie, CHMP Chair and General Directorate of the French agency, AFSSAPS 

Thomas Lönngren, Executive Director, European Medicines Agency 

The 22nd Annual EuroMeeting Plenary will start on 

Monday, March 8, 2010 at 13:30 and end at 16:00 

The goal is an engaged and lively exchange of ideas and positions that will set the scene for the rest of the meeting.

Special 

Sessions 

Student and Young Professional Sessions 

Session Co-Chairs: 

Annette Mollet, Head of Training and Education, ECPM European Center of 

Pharmaceutical Medicine, University Hospital, University of Basel, Switzerland 

Sonja Pumplün, Head Global Drug Regulatory Affairs, Actelion 

Pharmaceuticals, Switzerland 

The Student and Young Professionals Sessions are for those who are new to 

the pharmaceutical profession and for students who are interested in finding 

a way into the profession. Meet and exchange views with different key players 

in the health care system. Learn about different job profiles and continuous 

education and training possibilities to find a job in the pharmaceutical 

industry. Please join us and discuss with experts who are involved in the 

process. 

Monday, March 8, 2010, 9:00-10:30 

TRAINING AND JOB OPPORTUNITIES IN THE WORLD OF THE 

PHARMACEUTICAL INDUSTRY 

Meet and exchange views with different key players in the healthcare system. 

Learn about different job profiles, continuing education and training 

possibilities to find a job in the pharmaceutical industry. Please join us and 

take the opportunity to discuss with experts who are involved in the process. 

Finding the Right Job in the Pharmaceutical Industry 

Detlef Niese, Head External Affairs, Novartis Pharma AG, Switzerland 

Job Opportunities at the Health Authority 

Speaker to be confirmed 

European Postgraduate Training Platform 

Annette Mollet, Head of Training and Education, ECPM European Center of 

Pharmaceutical Medicine, University Hospital, Switzerland 

Monday, March 8, 2010, 11:00-12:30 

HOW TO PRESENT AND SELL YOUR SKILLS 

Please join us to hear from specialists on how to brand yourself and sell your 

skills. Improve your style and adapt it to an international pharmaceutical 

environment. You will have the opportunity to interact with experts from the 

healthcare industry. 

Brand Yourself 

Alex Khatuntsev, Human Resources Director, Actelion Pharmaceuticals Ltd., 

Switzerland 

Presentation Skills in English for a Job Interview 

Judy Churchill, Director, Language Consulting Services Ltd., UK 

How to Sell Yourself in an Interview 

Stefanie Zechner, Clinical Research Scientist, CTC Clinical Trial Consulting AG, 

Switzerland 

Agency Satellite Session 

Tuesday, March 9, 2010, 18:00-19:30 

FOCUS ON SMALL AGENCIES AND SMALL MARKETS 

Session Chair: 

Sif Ormarsdóttir, CHMP, European Medicines Agency, Clinical Assessor, 

Medicines Control Agency, Iceland 

The particular position and the challenges of small agencies are highlighted 

in presentations that address the pros and cons of being small in the current 

European regulatory environment. In what ways has the legislation of the 

European regulatory system benefited small agencies and how can small 

agencies cope with challenges in balancing between constantly growing 

national and EU needs? On the other hand, the mandate to contribute to the 

network, in particular to the European Medicines Agency activities, is the 

source of another set of challenges. Different solutions to fulfill the functions 

of an EU regulatory agency in 2010 are presented. The pharmaceutical 

industry’s experiences with small agencies is presented. Drug availability in 

small markets is an issue and the role of small agencies and the responsibility 

of industry to improve the access of drugs are discussed. 

The Pros of Small Agencies 

John-Joseph Borg, PDCO, CHMP, European Medicines Agency, Post-Licensing 

Director, Medicines Authority, Malta 

The Cons of Being Small 

Romaldas Maciulaitis, State Medicines Control Agency, Lithuania 

The Industry Perspective on Small Agencies and Small Markets 

Gudrun Dóra Gísladóttir, Director Regulatory Affairs, Actavis, Iceland 

Japanese Regulatory Session 

Wednesday, March 10, 2010, 11:00-12:30 

JAPANESE REGULATORY SESSION: PMDA UPDATE - INITIATIVES AND 

CHALLENGES FOR PROMOTING GLOBAL DRUG DEVELOPMENT 


Kyoichi Tadano, Director, Division of Planning and Coordination, PMDA, 

Japan 

In this session, you will hear a detailed review of the past year at PMDA as 

well as an overview of initiatives, milestones and current trends for the next 

year. You will hear directly from senior-level PMDA representatives on issues 

that may significantly affect your organisation’s regulatory operations. 

Future Directions and Challenges of PMDA 

Tatsuya Kondo, Chief Executive, PMDA, Japan 

Current Status of New Drug Reviews and Challenges to Promote Global 

Drug Development 

Satoshi Toyoshima, Executive Director and Director, Center for Product 

Evaluation, PMDA, Japan 

Current Projects for Promoting Global Drug Development including Japan 

Yoshiaki Uyama, Review Director, Office of New Drug III, PMDA, Japan 

7

8 

Session Topics in 

Specific Interest 

Areas 

1. Select your area of interest 2. Search under each day for relevant session numbers 

Interest Area Monday, March 8, 2010 Tuesday, March 9, 2010 Wednesday, March 10, 2010 

Clinical Research 0201, 0301, 0501, 1101 0104, 0105, 0202, 0203, 0204, 0205, 

0302, 0303, 0304, 0402, 0403, 

0404, 0405, 0502, 0505, 0704, 

0705, 0802, 0803, 1102, 1202, 1302, 

1103, 1104, 1203, 1204, 1303 

Pharmacovigilance 0301, 0601/0901, 0701, 0801, 1601 0105, 0204, 0205, 0301, 0303, 0304, 

0402, 0404, 0405, 0803, 0902, 

0903, 0904, 1005, 1105, 1205, 1405 

Regulatory 0301, 0401/1001, 0501, 0601, 0701, 

0801, 0901, 

0203, 0205, 0204, 0303, 0304, 

0305, 0402, 0403, 0405, 0502, 

0504, 0505, 0602, 0603, 0605, 

0702, 0703, 0802, 0803, 0804, 

0805, 0902, 1004, 1102, 1105, 1204, 

1205, 1404, 1405, 1602, 1603, 1604, 

1605 

Information Management 0201, 1101 0202, 0203, 0402,1004,1102, 1103, 

1104, 1105, 1203, 1303, 1304 

0106, 0107, 0206, 0207, 0208, 0308, 

0406, 0407/0807, 0408, 0506, 

0507, 0706, 1006, 1106, 1108, 1107, 

1306, 1307 

0106, 0107, 0206, 0207, 0208, 

0407/0807, 0507, 0906, 0907, 

1406 

0107, 0206, 0207, 0208, 0306, 0307, 

0308, 0406, 0407/0807, 0408, 

0506, 0507, 0606, 0607, 0608, 0707, 

0708, 0808, 1106, 1507 

0406, 0408, 1106, 1107, 1108 

Medical Devices 0601/0901 0104, 0105, 0502, 0802, 1402, 1403 0507, 0707, 0708, 0906, 1408 

Health Technology Assessment 0701 0104, 0202, 0203, 0403, 0404, 

0703, 1005, 1205 

0407/0807, 0907 

Generics 0401/1001 0204, 0205, 0402 0206, 0506 

Chemistry, 

Manufacturing & Controls 



0203, 0204, 0503, 1602, 1603, 1604, 

1605 

1308

Session Topics in 

Specific Interest 

Areas 

1. Select your area of interest 2. Search under each day for relevant session numbers 

Interest Area Monday, March 8, 2010 Tuesday, March 9, 2010 Wednesday, March 10, 2010 

Project Management 0301 0102, 0305, 0805 0107, 0307, 0408 

Quality Control and Assurance 0201 0202, 0203, 0204, 0205, 0305, 0503 0208, 0408, 0506, 

Public Policy and Law 0801, 1401 0502, 0602, 0802, 0804, 0805, 

1002, 1003, 1302 

0406, 0606 

Research and Development 1101 0602, 0603, 0604, 0802, 1104, 1105 0606, 0608, 1107, 1108 

Information Technology and 

e-Business 



1101 0704, 1102, 1103, 1104, 1105, 1405 1106, 1107, 1108 

Non-Clinical Safety and Efficacy 1601 0103, 0504, 0803, 0903, 1202, 1203 0108, 0306, 0506, 0408 

Statistics 1501 0105, 0403, 0404, 0704, 0905 0106, 0406, 0408, 0906, 0907, 1407 

Patient Involvement 0401/1001 0302, 0605, 0702, 1002, 1003, 1004, 

1005, 1305 

0607, 1006, 1007, 1008 

9

EuroMeeting 

Special Programmes 

Maureen McGahan is the Special Programmes Coordinator in the EuroMeeting team. 

Please contact Maureen for further information about any of the programmes detailed 

underneath: maureen.mcgahan@diaeurope.org or call +41 61 225 51 60. 

EuroMeeting Guidance Programme 

The DIA is committed to the active participation of students and emerging professionals 

in the EuroMeeting and to maximising the quality of their experience while attending the 

meeting. DIA will match students and young professionals with an experienced professional 

and coordinate a short meeting whilst in Monaco to share views, ideas and experience. 

• Benefits for the student/young professional include an opportunity to learn from an 

experienced professional 

• Benefits for the experienced professional include an opportunity to share experience 

and expertise 

Student Poster Abstracts: Deadline November 25, 2009 

A maximum of 20 abstracts are selected for the student poster presentation and a total of € 1,800 in prize money will be awarded to student winners. Benefits 

include one fully supported registration for the EuroMeeting to include: return flight to Monaco, three nights’ hotel accommodation and complimentary 

registration for the EuroMeeting. 

Professional Poster Abstracts: Deadline November 25, 2009 

A maximum of 40 abstracts from full-time professionals will be selected for the professional poster presentations. Selected professional poster presenters will be 

required to attend the meeting and pay the applicable registration fee and will be responsible for all other meeting expenses. 

Young Professional Fellowship: Deadline November 25, 2009 

DIA welcomes the involvement of emerging professionals in the EuroMeeting and provides complimentary admission to the EuroMeeting for 15 young 

professionals under the age of 30 in full-time employment. 

Student Fellowship: Deadline November 25, 2009 

DIA welcomes the involvement of students in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 students in full-time 

education. 

Patient Fellowship: Deadline November 25, 2009 

The DIA Patient Fellowship, now in its fifth successful year, is a programme to promote the participation of patients’ organisation representatives in the 

EuroMeeting. DIA fully supports 22 patient representatives covering travel, accommodation and complimentary meeting registration and is offering 25 additional 

patient representatives complimentary registration for the EuroMeeting. 

10 

Share your knowledge! 

Are you planning on attending the EuroMeeting in Monaco (March 8-10, 2010)? 

Are you an experienced professional? 

Are you willing to spare a couple of hours to offer guidance to a student 

or young professional during the EuroMeeting? 

If your answers are yes to all of the above, then the EuroMeeting team would love to hear from you. The EuroMeeting Guidance 

Programme puts students and young professionals in touch with experienced professionals at the EuroMeeting. The time 

commitment will be as much as you are able to offer, but a minimum of two hours’ contact with a student/young professional would 

be appreciated. It could involve activities such as attending the special networking lunchtime reception on Monday, March 8, 2010, 

spending some time reviewing the programme or perhaps attending a session together and discussing the content afterwards. This 

is a great opportunity to invest in the future of the pharmaceutical profession by sharing your expertise and experience. Please 

contact Maureen McGahan in the EuroMeeting team for further information about how you can get involved (email 

maureen.mcgahan@diaeurope.org or call +41 61 225 5160).

Pre-Conference Tutorials, Monday, March 8, 2010, 09:00 - 12:30 

ROUNDTABLE DISCUSSION 1 * 


GCP INSPECTION AND AUDIT FINDINGS 

Beat Widler, Global Head of Clinical Quality Assurance, F. Hoffmann-La Roche 

Ltd., Switzerland 

Fergus Sweeney, Head of Compliance and Inspection, European Medicines 

Agency, EU 

During the course of GCP Inspections some important themes are identified by 

the inspectors as being common to multiple inspections. In a similar way GCP 

auditors working for industry identify key issues of concern. This roundtable 

provides an opportunity to identify and discuss some of these key findings with 

a panel of GCP inspection experts from regulatory authorities and GCP audit 

experts from industry/academia. The topics selected for discussion will be 

chosen, by the panel, from responses to a short questionnaire circulated to 

registered participants. 

Discussion Objectives 

The purpose of this roundtable is to provide an opportunity for open, timely 

discussion of key GCP issues arising from inspection and audits: 

• Establish a common understanding of inspection and audit findings and their 

basis in regulation, guidance and quality principles 

• Build consensus on the priority issues for resolution 

• Better evaluate audit and inspection findings and their impact on GCP 

compliance and the ethical and scientific validity of clinical trials 

• Update on new issues/initiatives of regulators and of auditors 

Target Audience 

GCP compliance auditors and management, and staff with GCP-related QC 

responsibilities from both industry and academia; clinical research management 

and project leaders from both industry and academia; GCP inspectors 

* special roundtable price € 75.00 + VAT 

TUTORIAL 2 

HOT TOPICS IN PHARMACOVIGILANCE IN THE EU: EUDRAVIGILANCE 

ACCESS POLICY, INTERNATIONAL STANDARDISATION WORK E2B AND 

IDENTIFICATION OF MEDICINAL PRODUCTS, SIGNAL DETECTION, 

DUPLICATE MANAGEMENT 

Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk 

Management, European Medicines Agency, EU 

Gaby Danan, Expert in Pharmacovigilance, Senior Director, Global 

Pharmacovigilance and Epidemiology, sanofi-aventis, France 

This tutorial has been prepared to provide attendees with an overview on 

current hot topics in pharmacovigilance in the EU. The attendees will be offered 

the opportunity to discuss the latest developments related to the 

implementation of the new EudraVigilance Access Policy, the finalisation of the 

new international standards related to Individual Case Safety Reports (ICSR) 

and the Identification of Medicinal Products (IDMP), practical approaches in 

signal detection and duplicate management in the light of recent inspection 

findings. 

Learning Objectives 

At the conclusion of this tutorial, attendees will be able to: 

• Recognise the latest developments in obtaining access to EudraVigilance 

• Identify the main changes related to E2B and the reporting of medicinal 

product information 

• Discuss approaches in signal detection and duplicate management 


EU QPPV; people responsible for pharmacovigilance; people responsible for 

regulatory affairs; people responsible for Quality Assurance (clinical); people 

responsible for data management and systems operation in pharmacovigilance 

TUTORIAL 3 

GOOD VIGILANCE PRACTICES – HOW DO CONTINUOUS IMPROVEMENT, 

AUDITS AND INSPECTIONS CONTRIBUTE? 

Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany 

In view of the pharmaceutical package and existing obligations, this tutorial will 

review core safety processes and the associated quality management system 

including key performance metrics and regulatory feedback today and in the 

future. Regulatory authorities are increasingly enforcing work-intensive 

regulatory requirements in drug safety, while in parallel other initiatives strive 

for good pharmacovigilance practices. At the same time the pharmaceutical 

industry and their service providers are undergoing tremendous change and 

consolidation. Given the complexity of these tasks, the individual responsible 

for safety in pharmaceutical and biotech companies is overwhelmed by the 

need to adjust working practices to ensure compliance. Subject matter experts 

from both industry and regulatory will advise on the development of a frame 

work for best working practices from a pragmatic and cost-efficient 

perspective. Key elements will include process design and review, quality 

management, metrics, usefulness of audits and practical considerations for 

inspections. Options for organisational solutions will be presented and assessed 

for their implications on pharmacovigilance, including whether or not the 

concept of quality control and quality assurance supports the safety and wellbeing 

of patients as well as the transformation of the work environment into a 

collaborative, transparent and proactive entity. 



• Recognise the interaction and balance between drug safety processes and 

quality management 

• Discuss the validity of performance metrics 

• Analyse regulatory feedback 


Personnel working in drug safety /pharmacovigilance, QA and regulatory affairs 

in industry and at regulatory agencies 

TUTORIAL 4 

FROM PRESENT TO FUTURE: PSUR REGULATORY AND SCIENTIFIC 

CHALLENGES 

Giovanni Furlan, Head, Global Product Safety Analysis & Evaluation, Bracco 

Imaging SpA, Italy 

Carol Markwell, Director, Drug Safety Solutions, UK 

According to the European Commission, PSURs are currently only “line listings 

of adverse reactions”. An integrated “holistic” approach is needed for preparing 

PSURs: these are regulatory documents having a scientific scope. Therefore, the 

main PSUR regulatory and scientific challenges such as signal detection and 

evaluation, benefit/risk balance, cross links with other regulatory documents 

and PSUR planning will be discussed. Since multiple departments contribute in 

PSURs, it will also be illustrated how to streamline their preparation by applying 

human factor principles. 



• Recognise PSUR limits and scope 

• Adapt and comply with new PSUR requirements 

• Plan and streamline PSUR preparation 

• Perform benefit-risk evaluation in the context of a PSUR 


Medical writers; drug safety personnel involved in PSUR preparation, signal 

detection and benefit/risk evaluation. People from other departments involved 

in PSUR preparation may benefit from this tutorial. 

11

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This medium/high level tutorial is aimed at those who wish to increase their 

PSUR preparation skills and to be prepared for the challenges the new 

regulations will bring. 

TUTORIAL 5 

OPERATION OF EUROPEAN REGISTRATION PROCEDURES: CENTRALISED, 

MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES 

Truus Janse-de Hoog, Staff Member MEB, European Cluster, Chair CMD(h), 

Medicines Evaluation Board, The Netherlands 

European Medicines Agency instructor invited 

Presented by representatives from a national authority and the European 

Medicines Agency, this tutorial will provide a pragmatic view on how EU 

registration procedures work. The basic principles of the centralised, mutual 

recognition and decentralised procedures will be explained. Hints and tips will 

be given on how to avoid delays in the procedures and how to prepare for 

submission of applications that can involve 30 Member States. 



• Understand the basic principles of centralised, decentralised and mutual 

recognition procedures 

• Recognise the difficulties that can be experienced during the operation of 

these procedures and apply practical solutions 

• Describe the main differences in the procedures and decision-making 

processes 


Regulatory affairs, pharmaceutical industry personnel and students 

TUTORIAL 6 

INTERACTIONS BETWEEN THE REGULATORY REGIME AND THE LEGAL 

PRINCIPLES GOVERNING INTELLECTUAL PROPERTY, COMPETITION AND 

PRODUCT LIABILITY FOR NON-LAWYERS 

Geneviève Michaux, Of Counsel, Covington & Burling, Belgium 

Interactions between, on the one hand, the regulatory regime and, on the other 

hand, intellectual property, competition and product liability rules are 

increasing. As a result, those matters can no longer be approached in isolation, 

and a more comprehensive perspective is required when addressing regulatory 

issues. This tutorial will explain key concepts of the laws governing intellectual 

property, competition, and product liability and discuss how they relate to the 

regulatory pharmaceutical regime. This tutorial is designed for non-lawyers with 

considerable regulatory experience and for regulatory lawyers who want to 

learn the basics of intellectual property, competition and product liability rules 

as they apply in the pharmaceutical sector. 



• Explain and discuss the basics of intellectual property competition and 

product liability rules applicable to medicinal products 

• Identify and better address the regulatory issues that present an intellectual 

property, competition or product liability aspect 


All persons involved in regulatory affairs and in-house regulatory lawyers 

TUTORIAL 7 

QUALIFIED PERSON FOR PHARMACOVIGILANCE (QPPV): WHAT DO YOU 

NEED TO KNOW? 

Keith Wibley, Director Pharmacovigilance, NDA Regulatory Science Ltd., UK 

Janet Hormbrey, Executive Director, EU Qualified Person for Risk Management 

& Pharmacovigilance, Merck Sharpe & Dohme, Belgium 

EU legislation and the detailed guidance in Volume 9A require all marketing 

authorisation holders to have a qualified person for pharmacovigilance (QPPV) 

with responsibility for establishing and maintaining all aspects of a marketing 

authorisation holder’s (MAH’s) pharmacovigilance system in the EU, as well as 

this system’s interfaces with other regions of the world. Although 

acknowledged to be a vital function, there is little practical guidance on how 

QPPV responsibilities should best be discharged, while maintaining compliance 

with regulatory requirements. The responsibilities of the QPPV apply wherever 

there is an active MA for a product authorised in the EU/EEA. Thus the role in 

many companies has a global impact. During this tutorial we will discuss and 

advise on current practice to help address issues such as: 

• What does being qualified mean in practice for the QPPV and their 

organisation? 

• What are appropriate contractual obligations and job description to cover 

points such as 24-hour availability, workload, personal indemnity, delegation 

and adequate back up? 

• How QPPV activities should be documented to ensure adequate quality 

assurance 

• How inspectors and regulatory authorities regard the QPPV role and their 

expectations for the level of the QPPV’s involvement in the global PV system 

• How recent changes to Volume 9A impact the QPPV role 

• How to make the QPPV role work in practice using examples from both large 

and small companies and external contract QPPVs 

• When a QPPV changes, what to do and how to notify authorities 

• How to optimise interactions between the company as a whole and the QPPV 

to obtain adequate mutual oversight and support 

• What should be the QPPV’s input into post-authorisation commitments, postauthorisation 

studies, PIPs and risk management plans? 

• How should the interface between the QPPV and different functions such as 

regulatory affairs, clinical development, product quality, QA and marketing 

work in practice? 

• How to ensure the appropriate authority and influence for a QPPV in different 

types of organisation 

• How the QPPV function relates to national nominated individuals for safety 

The speakers will also update the audience about whether there should be an 

appropriate forum to allow QPPVs across the industry to interact and share best 

practices to the mutual benefit of public health and industry alike. 



• Explain legal, regulatory and business implications surrounding the QPPV 

function in order to permit the effective implementation of this role 

• Describe the expectations different stakeholders have of a QPPV 

• Understand the different approaches taken by various companies and the 

influence company size and product portfolio can have on this 

• Gain better insight into the evolving requirements of regulators and inspectors 


Professionals in companies who are involved in running or setting up 

pharmacovigilance operations in the EU/EEA, or with responsibilities for postmarketing 

clinical safety and who are involved in: pharmacovigilance; clinical 

research; risk management; medical product safety assessment; data analysis; 

epidemiology; labelling; quality assurance and compliance; QPPVs; Deputy 

QPPVs; and contract research organisations and consultants



TUTORIAL 8 

ADAPTIVE DESIGNS FOR CONFIRMATORY CLINICAL TRIALS 

Norbert Benda, Statistical Methodologist, Novartis Pharma AG, Switzerland 

This tutorial will give an introduction to the theory and practice of adaptive 

designs for pivotal clinical trials. Adaptive designs allow for mid-course design 

modifications such as the adjustment of sample size, the dropping of treatment 

arms or the selection of a subpopulation. We will review and discuss statistical 

methodology that allows such adaptations without compromising the overall 

type I error rate. All methods will be illustrated by examples. Several case 

studies will be presented, explaining in detail both methodological and practical 

issues which arise in designing and analysing an adaptive clinical trial. 



• Understanding the principles, opportunities and challenges for adaptive 

designs 

• Understand operational considerations 


Clinical project team members within drug development 

TUTORIAL 9 

IMPLEMENTATION OF THE EU VARIATION REGULATION: 

WHY – WHEN – WHAT 

Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, 

Denmark 

Peter Bachmann, Senior Expert, European Drug Regulatory Affairs and German 

Member of the CMD(h), BfArM, Germany 

The EU variation regulation came into force 1 January, 2009 and is mandatory 

to use from 1 January, 2010. What is the first impression on whether the 

implementation will provide a simpler, clearer and more flexible regulation for 

variations within Quality – Safety and Efficacy? 


At the conclusion of this tutorial, attendees will be able to obtain an overview 

of: 

• Key issues from the EU variation regulation and implementation guidelines 

• How is the EU variation regulation compared to the US system? 

• Whether the implementation will give a simpler, clearer and more flexible 

regulation for variations within Quality – Safety and Efficacy? 

• Changes to biologicals compared to chemical entities – any differences? 

• What is a regulatory pre-approved protocol? 


People involved in lifecycle management regulatory issues of late-stage 

development drug products and lifecycle management of approved products 

within quality/production, safety, clinical and regulation. 

TUTORIAL 10 

ORPHAN DRUGS IN THE EU: FROM DESIGNATION TO MARKETING 

AUTHORISATION 

Katrin Rupalla, Associate Director, Regulatory Affairs Europe, Celgene 

International SARL, Switzerland 

Jordi Llinares, Head of Orphan Medicines, European Medicines Agency, EU 

In this tutorial you will hear about the orphan drug legal framework in general 

and what are the latest updates. In addition, this tutorial is meant to provide an 

overview of the orphan drug application process from designation to approval 

of marketing authorisation and its practical implications based on recent 

examples. This also includes in-depth review and analyses of topics such as 

orphan market exclusivity, similarity and significant benefit. Speakers will 

include experts from the European authorities, but you will also hear from 

industry representatives about the strategic aspects, experiences and learnings 

with regard to regulatory framework for orphan drugs in the EU. 



• Apply the information they have obtained on procedures and requirements for 

an orphan drug application in the EU and US 

• Identify and respond to potential issues that may arise during an orphan 

designation procedure 


This tutorial will be of interest to all those who would like to hear about the 

latest update of the orphan drug legal framework in the EU and most recent 

experience with regard to practical implications. They will be, in general, 

professionals from drug regulatory affairs, clinical science and public affairs. 

TUTORIAL 11 

SIGNAL DETECTION METHODS FOR BEGINNERS – OVERVIEW AND CASE 

STUDIES 

Steve Jolley, Principal, SJ Pharma Consulting, USA 

Jacinta Aniagolu, Director, Pharmacovigilance & Risk Management, 

Synowledge, LLC, USA 

This tutorial will provide a theoretical and methodological review of the 

application of signal detection and data mining techniques to safety 

surveillance. An overview of strategies and specific situation applications will be 

presented. 

Highlights: 

• Recommended approach to signal detection and use of data mining 

techniques 

• Use of visualisation tools to enhance signal detection 

• Comparison of approaches for a large and small company 

Specific topics covered will include: 

• Analysis of demographics, risk assessment, dose effects, product interactions, 

and differences from known background rates 

• Strategies for incorporating all relevant data sources, including clinical trials, 

individual case reports, PSURs, external databases (FDA, WHO), and registries 

• Understanding the benefit/risk ratio of a product and how to discover product 

adverse event relationships 

• Measuring the strength of the relationship of the adverse event and the drug 

using the Bayesian Confidence Propagation Neural Network algorithm 

(BCPNN) 

• Illustration of the power of technology that can not only provide overall 

analysis, but also “drill down” to specific patient records 



• Recognise the basic concepts of data mining and principles of signal detection 

• Outline how to apply these techniques within their company 

• Discuss data mining techniques to analyse large volumes of adverse event 

report data 


Clinical safety professionals involved in pharmacovigilance; 

pharmacoepidemiology; regulatory affairs; quality assurance; 

medical product safety assessment; labelling 

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TUTORIAL 12 

ANALYSIS OF SAFETY DATA FROM CLINICAL TRIALS 

Jürgen Kübler, Global Head, Statistical Safety Sciences, Novartis Pharma AG, 

Switzerland 

Joachim Vollmar, Executive Consultant, International Clinical Development 

Consultants, USA 

This tutorial is a combination of theory, guidelines, practical considerations and 

real-life solutions for those working in the clinical development environment 

(pharmaceutical, biotech industry or CRO). The aim of this course is to provide 

a basic understanding of the underlying methodology and the current 

guidelines on safety data. Aspects regarding the planning of clinical trials as 

well as the problems and pitfalls during the analysis of safety data will be 

presented. The presentations will also include case studies. 



• Understand relevant guidelines and regulatory requirements 

• Contribute to safety analysis plans 

• Assess statistical safety analyses 

• Identify pitfalls in safety analyses 


Clinical researchers; drug safety specialists; medical writers; investigators; 

biostatisticians; and project managers 

TUTORIAL 13 

THE "QUALITY-BY-DESIGN" INITIATIVE – A LOOK INSIDE FROM MULTIPLE 

ANGLES 

Gert Thurau, Associate Director, Merck & Co., Inc., USA 

Quality-by-Design (QbD) is a concept that has the potential for introducing 

transformational changes to the way pharmaceutical products are developed, 

registered and manufactured. With the regulatory aspect of QbD anchored 

around the ICH guidelines ICH Q8, Q9 and Q10, industry has embraced QbD as 

beneficial for both the patient and their business processes in R&D and 

manufacturing. On the technical level QbD supports concepts like risk 

management, continuous improvement and the overall modernisation of 

pharmaceutical manufacturing. This new concept is also expected to be 

implemented into the EU Variations framework via the revised legislation. A 

reality check of the much described vision will be performed, based on recent 

implementation of QbD concepts into practice by several pharmaceutical 

companies both in newly developed and in line products. This tutorial will give 

an introduction to the overall framework of QbD as well as provide an overview 

of regulatory and technical approaches currently discussed and utilised to push 

the envelope beyond the previously accepted boundaries, including the 

utilisation of enablers like risk management and Process Analytical Technology 

(PAT). Both of these previously existing approaches have been recognised as 

core tools for QbD practitioners, leading to true benefits like continuous 

improvement or real-time product release testing. Presentations on both 

industry and regulatory interpretations and expectations will be combined with 

an overview of currently available guidance and interpretation. Finally, real-life 

examples of QbD will help to illustrate what opportunities QbD is opening up 

and where its real potential lies for the enhancement of the post-approval 

framework to ensure the safety and benefit of patients. 



• Identify and analyse Quality by Design (QbD) approaches to product and 

process development 

• Assess the current regulatory positions on QbD 

• Define how the concept could be used in their own work to further patient 

safety and benefits 


Physicians, pharmacists and pharmaceutical scientists involved in product 

(synthesis and formulation) and manufacturing process development; 

regulatory personnel involved in drug registration (CMC); manufacturing 

personnel with innovation needs; regulators with interest in real-life QbD 

examples 

TUTORIAL 14 

RECENT EUROPEAN REGULATORY KEY ASPECTS OF BIOPHARMACEUTICALS 

Gabriele Dallmann, Director Biopharmaceuticals, NDA Regulatory Science Ltd., 

Germany 

Paul Chamberlain, Principal, bioLOGICA Consulting, France 

The tutorial provides the attendees with an overview of recent key aspects of 

activities in the area of biopharmaceuticals. It covers newly suggested, drafted 

and finalised regulatory guidelines related to biopharmaceuticals, the main 

activities of committees and working parties of the European Medicines Agency 

with a focus on the first year of the CAT, and decisions on marketing 

authorisation applications of biopharmaceuticals via the centralised procedure. 

Based on this, the discussion will include an overview of recent marketing 

authorisations and refusals and their reasons, the implementation of the 

certification process for ATMPs, the experience with first authorisations of 

ATMPs, the preparation of a regulatory guideline on biosimilar monoclonal 

antibodies, an update on the plasma master file and pandemic influenza vaccine 

activities, feedback on experience with Quality-by-Design or platform 

technology dossiers and challenges in the investigation of comparability and 

immunogenicity upon introduction of changes into the manufacturing process. 


• Recognise the current trends in biopharmaceutical-related regulatory 

guideline developments and decisions on marketing authorisations in Europe 

• Appraise the activities of the CAT and biopharmaceutical-related working 

parties of the CHMP 

• Interpret recently developed guidelines in their impact on scientific data 

requirements 

• Estimate how these trends impact current development projects in your 

company 


Experts of regulatory affairs, R&D and process development departments, 

involved in the investigation of new biopharmaceuticals including ATMPs and in 

the preparation of CTDs for marketing authorisation applications via the 

centralised procedure 

TUTORIAL 15 

AFTER THE PIP DECISION: MODIFICATION OF THE AGREED PIP, VALIDATION 

AND COMPLIANCE CHECK 

Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, EU 

Behrouz Kassai, Associate Professor Department of Clinical Pharmacology, Coordinator 

Paediatric Clinical Investigation Centre/INSERM, Coordinator for 

EPICIME, University of Lyon, France 

This tutorial is aimed at illustrating the steps that follow the European Medicines 

Agency decision on an agreed PIP (or on a waiver), including the request for 

modification of an agreed PIP, applications for a new PIP (for the same 

product), and the procedures at the time of validation/compliance check. 



• Decide whether an agreed PIP requires an application for modification 

• Judge when a new PIP application should be submitted, versus a request for 

modification of the agreed PIP 

• Differentiate between validation and compliance check 

• Compose an application to the PDCO requesting an interim or final



compliance check. 


Regulatory affairs staff from pharmaceutical companies; National Competent 

Authority staff who validate applications for marketing authorisation, line 

extensions, or type II variations; any person who is involved in the PIP process 

TUTORIAL 16 

INTRODUCTION TO EU MEDICAL DEVICE REGULATION 

Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical 

Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The 

Netherlands 

Erik Vollebregt, Attorney, Greenberg Training, The Netherlands 

This tutorial will give a condensed overview of the EU device legislative system 

and the principles and philosophy behind it. It will explain the definition of a 

medical device and the demarcation between medical devices and 

pharmaceuticals. It will also explain risk classification of medical devices and the 

relation between risk classification and conformity assessment procedures. It 

will highlight the role of the notified bodies and the main provisions on drugdevice 

combination products. 



• Understand the main characteristics of the EU Medical Device regulatory 

system 

• Understand the main topics of the EU Medical Device Directive (Directive 

93/42 as amended by Directive 2007/47), including the provisions on risk 

classification, combination products and delineation with pharmaceutical 

products 

• Understand the provisions of Directive 2007/47 which come into force on 21 

March 2010 

• Understand the system of conformity assessment by Notified Bodies 


Professionals in the pharmaceutical area (e.g., regulatory affairs, clinical 

development) who are involved in the development and marketing of drugdevice 

combinations; professionals in the pharmaceutical area (e.g., regulatory 

affairs, clinical development) who would like to obtain a condensed overview of 

the EU Medical Device regulatory system; DIA EuroMeeting 2010 participants 

planning to attend the “hot topic” sessions on Drug Device Combinations. 

TUTORIAL 17 

INTRODUCTION TO EUROPEAN REGULATORY AFFAIRS 

Brenton James, Consultant in Strategic Regulatory Affairs in the European 

Union, UK 

This tutorial will explain and compare the three regulatory procedures available 

in the European Union for a marketing authorisation application. Key business 

aspects of co-marketing and co-promotion will be outlined together with the 

importance of translations and trademarks. 

Learning Objectives. 


• Describe the main advantages and disadvantages of the centralised, 

decentralised and mutual recognition procedures 

• Where there is a choice, discuss which procedure is optimal to new chemical 

entities, OTC and generic products 


Regulatory affairs; clinical research; project management; agency staff 

TUTORIAL 18 

DATA PRIVACY IN CLINICAL TRIALS AND PHARMACOVIGILANCE 

Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability 

Standards, sanofi-aventis R&D, France 

This tutorial will explain; 

• Why is personal data protection important? 

• Principles of personal data protection, based on the European Regulations. 

• Overview of worldwide regulations and the differences between them. 

• Specific regulations for biomedical research and pharmacovigilance and their 

consequences. 

• How to comply? 

• Information and consent 

• Communication and training 

• IT security and validation 

• Legal instruments (contracts, Safe Harbor, BCRs) 

• Data privacy organisation 



• Understand the principles of personal data protection in the European Union 

• Understand the differences between European, US and Asian data privacy 

regulations 

• Have a basic knowledge on how to comply with European and other 

worldwide regulations 


All individuals involved in the organisation and management of clinical trials 

and pharmacovigilance, or handling with data collected to perform these 

activities 

TUTORIAL 19 

REFERRALS TO CHMP- HOW ARE THEY HANDLED? 

Anabela de Lima Marçal, Head of Community Procedures, European Medicines 

Agency, EU 

Thomas Larsson, Scientific Administrator, Community Procedures, European 


Based on case studies and actual experience, this tutorial will provide an indepth 

understanding of the practical implications of referral procedures to the 

CHMP under Articles 29, 30, 31 and 107, outlining the impact of the various 

referral procedures and identifying what is expected from the industry, and 

equally important, what is expected from the regulatory authorities. 



• Assess the specific implications of the various referral procedures to the CHMP 

under Article 29, 30, 31 and 107 of Directive 2001/83/EC, as amended 

• Recognise the benefits to be gained from undergoing a referral procedure 

• Identify what is expected from companies involved in referral procedures and 

the support and tools provided by the Regulatory Authorities 


Regulatory affairs professionals from industry, product leaders from generic 

companies and innovators who: 

• Are currently involved in a referral procedure 

• Will be involved in future referral procedures 

• Consider triggering themselves a referral procedure 

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TUTORIAL 20 

eCTD SUBMISSION COMPILATIONS FOR THE EU 

Olaf Schoepke, Managing Director, Extedo Ltd. UK 

This tutorial will guide the participants through the process of creating and 

validating eCTD submissions for the EU. The process will focus on regional 

requirements and correlations between the different procedures. Relevant 

guidelines will be addressed and methods discussed preparing participants for 

successful eCTD submissions. 


At the conclusion of this tutorial, attendees will be able to answer the following 

questions: 

• What are the basic requirements of eCTD submissions in Europe? 

• How do I handle the different procedures in Europe? 

• What approach to filing electronically can I recommend? 

• How can I build and validate a compliant eCTD? 

• What are common pitfalls during eCTD assembly? 


Regulatory; IT; document management; medical writer; publisher: submission 

manager 

TUTORIAL 21 

HEALTH TECHNOLOGY ASSESSMENT: EVERYTHING YOU EVER WANTED TO 

KNOW BUT WERE TOO AFRAID TO ASK! 

Kym Alnwick, HTA Technical Lead, Heron Evidence Development, UK 

Using practical examples, this tutorial aims to provide a contextual overview of 

the basic concepts involved in global health technology assessment. An 

introductory description of the stakeholders, methods, and debates in the field 

will be provided. Participants will learn how the various components of HTA 

require expertise from various disciplines including clinical evidence review and 

synthesis, economic modelling, and medical writing. 



• Identify the key components of HTA 

• Describe the development and global context of HTA, including HTA as a ‘4th 

hurdle’ requirement 

• List the aims of HTA agencies and other stakeholders; describe how HTA 

guidance is used and list categories of guidance 

Accreditation and Credit Designation 

• Define the main methodological terms used in HTA 

• Compare and distinguish the requirements of 3/4 major HTA agencies 


This tutorial is intended for those with an interest in global developments in the 

pharmaco-economic appraisal of new health technologies, including 

professionals in regulatory affairs, corporate or government affairs, and health 

policy, as well as academics and clinicians. In addition this tutorial will be 

relevant to those interested in understanding the place of comparative 

effectiveness research (CER) relative to HTA. 

The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical 

education for physicians. 

The American Medical Association has determined that physicians not licensed in the US who participate in this CME activity are eligible for AMA PRA category 1 

credit. 

Select sessions may offer AMA RA Category 1 Credits and will be clearly identified in the final programme. 

The Drug Information Association (DIA) has been approved as an “Authorized Provider” by the International Association for Continuing Education and Training 

(IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102. 

The DIA is authorised by IACET to offer 1.5 CEUs for this programme. 

Best-in-Class Content, 

First-Rate Instructors 

First-rate instructors and best-in-class content are what make DIA’s training 

programmes the highest quality training programmes available anywhere. 

DIA offers a variety of courses in regulatory affairs, clinical research, 

non-clinical sciences and safety and pharmacovigilance. Benefits include: 

• Continuing education credits 

• Up-to-the-minute coverage of important industry hot topics 

• Expert faculty actively practicing in their particular discipline 

• Networking opportunities 

• Consistent course materials from one offering to another 

• Expert training from faculty who are professionals in the pharmaceutical 

and related industries 

• Limited attendance allows for a more personal quality learning 

experience 

• Tailor-made case studies and instructor-led group work 

• In-depth discussion of specific contemporary issues 

For more information and a complete listing of all training courses, please 

visit www.diahome.org and click on educational offerings. 

If you would like to receive a statement of credit, you must attend the programme, return your evaluation form and complete the online credit request process 

through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request.

Greening the 

EuroMeeting: 

Towards an 

Environmentally 

Friendly Conference 

Green meetings are a growing trend at conferences, and DIA’s EuroMeeting is at the forefront of this movement. Using practical, 

innovative and often very simple measures successfully reduces our carbon footprint. We will be practicing the 3Rs in Monaco: reduce, 

recycle and reuse. 

The 22nd Annual EuroMeeting will take place at the Grimaldi Forum Convention Centre in Monaco (March 8-10, 2010), and we have 

chosen a convention center partner that shares our vision of a sustainable EuroMeeting. The infrastructure is already in place at the 

Grimaldi Forum in areas such as the use of a seawater pumping system to provide energy for the air conditioning system which reduces 

energy requirements by 20-30%, low energy lighting throughout the building, and motion-sensitive taps for water, hand driers, and an 

eco-efficient flushing system for the toilets. Remarkably, the Grimaldi Forum has virtually zero emissions of greenhouse gases. 

Given that Monaco is only 2 km 2 

, everything is close. Most of the hotels are a short walking distance from the Grimaldi Forum – and if 

you do want to take a bus (free with your conference badge), they are all dietered powered (diesel mixed with vegetable oil). We will 

be running complimentary shuttle buses to and from Nice Côte d’Azur Airport, thereby reducing the need for individual car transfers. 

DIA offsets the air miles of staff travelling to the EuroMeeting with a Swiss nonprofit foundation, myclimate – The Climate Protection 

Partnership (www.myclimate.org), and we encourage all our participants to support our greening initiative by considering offsetting 

their miles. 

During the EuroMeeting, we will offer you an environmentally-friendly conference bag when you collect your badge (which of course, 

we will recycle at the end of the meeting if you return it to us). Recycling bins throughout the building will collect paper, cardboard, 

plastic, packaging containers, glass and batteries. The meeting will be paperless wherever possible, and all EuroMeeting publications 

will be printed on FSC-certified paper, which means that they are sourced from well managed forests and recycled wood. 

Working with our exhibitors is an important part of the EuroMeeting, and we look forward to a successful partnership in 2010. The first 

Greenest Exhibitor Award was presented at the EuroMeeting in Berlin to Rachel King, CEO of CRF Health, and we are looking forward 

to increased competition amongst our exhibitors to win the 2010 Award. 

We commit to not using styrofoam, paper or plastic cups, plates or cutlery. There will be water coolers throughout the building, 

reducing the need for individual bottles of water. Locally grown food will be used wherever possible with participants will be able to 

eat healthily as low down the food chain as possible, with some delicious vegetarian menus on offer. 

If you have any suggestions or creative ideas on how we could do more, please contact Dermot Ryan, EuroMeeting Manager at 

dermot.ryan@diaeurope.org. 

17

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Theme 1 


Theme 1 

Innovation 

Theme Leaders: 

Jackie Hunter, Senior Vice President, Science Environment Development, 


Damian O’Connell, Vice President Clinical R&D, Global Research and 

Development, Pfizer, Ltd. UK 

New medicines development is going to require innovation at all stages of the 

drug discovery and development process. The challenges that companies face 

in bringing medicines to the market, in ways that are both time and cost 

effective, are huge. These challenges are driving new ways of working both 

within companies, between companies and between academia and industry. 

The Innovative Medicines Initiative is a public-private partnership that will drive 

pre-competitive data sharing and new ways of working between industry and 

academia. Open innovation has produced demonstrable benefits for other 

industries – could it do the same for pharma? This theme will examine where 

the boundaries might lie for both pre-competitive data sharing and open 

innovation. New clinical designs and methodologies are being employed both 

for clinical trials and experimental medicine studies and some of these 

approaches will be discussed. Finally some examples of innovation in 

translational medicine and pre-clinical studies will be described. 


16:30 Session 0101 

THE INNOVATIVE MEDICINES INITIATIVE 


Michel Goldman, Executive Director, IMI, EU 

The Innovative Medicines Initiative (IMI) is a public-private partnership aiming 

at boosting drug innovation across Europe. With the European Federation of 

Pharmaceutical Industries and Associations (EFPIA) and the European 

Commission as stakeholders, IMI will launch collaborative R&D, and education 

and training projects on key issues of common interest to industry, academia 

and patients. In this framework, new approaches to pharmacovigilance will be 

an important aspect of IMI activities. This session will present the current status 

of IMI development with a focus on the projects related to pharmacovigilance. 

On the Way to a New Pharmacovigilance Model through the Innovative 

Medicines Initiative: Protect 

Elizabeth Swain, Director, Medical Advocacy, Policy and Patient Programmes, 


On the Way to a New Pharmacovigilance Model through the Innovative 

Medicines Initiative: EU2P 

Debra Szafir, Head Safety Risk Management Strategy, Roche, France 

Lessons learned from the IMI - Inception to implementation 

Jonathan Knowles, President of Global Research, F. Hoffmann-La Roche AG, 

Switzerland 

Panel discussion with Hans-Georg Eichler, Senior Medical Officer, European 


Tuesday, March 09, 2010 

09:00 Session 0102 

IS AN OPEN INNOVATION PARADIGM THE WAY FORWARD FOR PHARMA? 


Susie Stephens, Director of Biomedical Informatics, Johnson & Johnson 

Pharmaceutical Research & Development, USA 

What is open innovation and why is it relevant to the pharmaceutical industry 

and biomedical research? An open innovation approach has provided benefit 

for other industries such as electronics and telecommunications. Many of these 

industries faced similar issues to those currently experienced by the 

pharmaceutical industry. 

What Are the Lessons for Pharma from Other Industries? 

Wil Schoenmakers, Partner, PA Consulting Group, UK 

Gaining Efficiencies through Open Innovation 

Susie Stephens, Director of Biomedical Informatics, Johnson and Johnson 

Pharmaceutical R&D, UK 

Getting More with Less: Leveraging communities to build enterprise research 

systems 

Claus Stie Kallesoe, Chief Specialist, Global Head of Research Informatics, H. 

Lundbeck A/S, Denmark 

Toward a Shared Data Element Dictionary: Conversion to ODM 

Bruce R. Basson, Data Standards Consultant, Eli Lilly and Company, France 

11:00 Session 0103 

THE IMPORTANCE OF PRE-COMPETITIVE DATA SHARING TO ACCELERATE 

DRUG DEVELOPMENT 


To be confirmed 

• What are the issues around data sharing? 

• Successful examples of pre-competitive data sharing – Clinical and pre-clinical 

A Pharmaceutical Consortium: An innovative approach to risk mitigation for a 

rare event: PML 

Sophie Banzet, Clinical Scientist, F. Hoffmann-La Roche AG, Switzerland 

Pre-Clinical Pre-Competitive Standards, Data Sharing and Integration – 

Pistoia: A new paradigm 

Bryn Williams-Jones, eBiology Group, Pfizer, UK 


WHAT IS AN INNOVATIVE MEDICINE? 



• How do we measure innovation? 

• How will payers reimburse innovation? 

• What does innovation look like from the patient perspective? 

• Where are the incentives for developing novel anti-infectious agents? 

Where Is the Future Innovation for New Medicines Going to Come from? 

Tacye Connolly, Director, RRG Consultancy, UK 

Does Nanomedicine Need a Specific Regulatory Framework? 

Linda Lebon, Project Director, Voisin Consulting, France 

Is the EU Environment Sufficient Incentive to Develop New Indications for 

Well-Established Drugs? 

Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, 

Denmark 


INNOVATION IN EARLY AND LATE PHASE CLINICAL TRIALS I 


Judith A. Quinlan, Vice President, Adaptive Clinical Trials, Cytel, Inc., USA 

• What impact can adaptive designs have on timelines and cost? 

• Can innovative trial design reduce risk? 

Recent Advances in Adaptive Clinical Trial Designs 

William Sietsema, Vice President, Regulatory Consulting and Submissions, 

Kendle International Inc., USA.


Adaptive Development: A leap forward in efficiency 

Michael J Rosenberg, President and CEO, Health Decisions Inc., USA 

Logical Considerations in the Implementation of Adaptive Trial Designs 

Eva R. Miller, Director, Biostatistics, ICON Clinical Research, USA 



INNOVATION IN EARLY AND LATE PHASE CLINICAL TRIALS II 


Michael Krams, Vice President, Adaptive Trials and Applied Program 

Strategies, Wyeth Research, USA 

• What impact can adaptive designs have on timelines and cost? 

• Can innovative trial design reduce risk? 

Adaptive Design in Confirmatory Trials: A way forward 

Solange Corriol Rohou, Director, Regulatory Affairs, AstraZeneca, France 

Flexible Trial Design: New techniques in interim analysis 

John Whitaker, Vice President, Biostatistics and Scientific Programming, Kendle, 

USA 

Exploiting Scientific Intent of ICH Guidelines to Accelerate Proof of Concept 

Richard Williams, Vice President, Regulatory and Strategic Drug Development, 

INC Research, USA 

Adaptive Trials: Too complicated for too little return? 

Bill Byrom, Senior Director, Product Strategy, Perceptive Informatics, UK 


HAVE THE BENEFITS OF TRANSLATIONAL MEDICINE BEEN REALISED? 


Damian O’Connell, Vice President, Clinical R&D, Global Research and 


Developments in translational medicine, triggered in response to the 

pharmaceutical industry's ongoing attrition, have come to the centre of many 

companies exploratory development paradigms. These translational strategies 

have been highlighted by both the European Innovative Medicines' and FDA’s 

Critical Path Initiatives as means to catalyse new opportunities for innovation in 

early clinical R&D and help select mechanisms most likely to lead to 

breakthrough therapies. This session will look at how various companies have 

implemented translational medicine strategies in different therapeutic areas to 

make better and more informed choices around candidates to accelerate from 

research to proof of concept and the impact of translational medicine on their 

success rates in achieving positive POCs. 

Pre-Clinical and Clinical Development of Anticancer Pharmaceuticals 

Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, 

Germany 

Translational Research in the Pharmaceutical Industry: From theory to reality 

Damian O’Connell, Vice President Clinical R&D, Global Research and 


Experimental Models of Pain 

Boris Chizh, Platform Director, Pain & Neurophysiology, GlaxoSmithKline, UK 


INNOVATION TO REDUCE ATTRITION 




Theme 1 - Theme 2 

• Predictive validity in animal models 

• Innovations in target discovery and validation 

• Updates on clinically relevant animal models 

• Novel methods to identify clinically important new treatments pre-clinically 

Addressing the Impact of Protocol Complexity on Clinical Trial Performance 

Kenneth A. Getz, Senior Research Fellow, Center for the Study of Drug 

Development, Tufts University; Chairman, CISCRP, USA 

Regulatory View 

Spiros Vamvakas, Head of Scientific Advice, Technical Coordinator for ICH, 


Theme 2 

Staying in Business: How to make sure you comply with all 

rules and regulations, quality, compliance and external 

challenges 


Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche 

AG, Switzerland 

Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany 

In the EU, the Pharmaceutical Package and in other countries, other new rules 

and regulations have created new obligations. Also, advocacy groups, the 

public and the media – the scientific as well as the general press – are 

becoming more active and questioning. This makes the development of new 

medicines more and more demanding, not only from a clinical and scientific 

perspective but also from a process and regulatory aspect. Globalisation is, for 

instance, seen by some as progress as patients in developing countries are 

getting access to innovative medicines through earlier involvement in clinical 

trials and because of a strengthening of local economies through improved 

healthcare systems. Others are fearful that there is a shift in the focus of clinical 

development from industrialised countries to Asia and Latin America, thus 

depriving investigators in these “traditional” regions of access to clinical trials, 

and trials in developing countries are a new form of colonialism and result in the 

exploitation of vulnerable populations. The counter argument to this is a not 

uncommon topic in the debate about development: protection of patients in 

developing countries by well-intentioned and often self-nominated advocates 

from the so-called industrialised countries is nothing other than paternalism. 

Two sessions will look at this conflict and give background information about 

patients, the healthcare system and risks and benefits when conducting clinical 

trials in India and Latin America. In this context the expectations by the public 

for transparency do not come as a surprise and will be the topic of another 

session. Misuse of medicines and counterfeiting are other facets of globalisation 

and closely linked to the widespread use of the Internet. A session will review 

the so far rather neglected topic of misuse of therapeutic agents in doping. 

Doping would not be made so easy without manufacturing capacities in 

countries with weaker regulatory controls and e-commerce, and this leads to 

another session about counterfeiting. New regulations and mounting pressure 

are also an opportunity for smarter strategies and the use of “intel-ligence” for 

study management and quality oversight: progress of the Clinical Trial 

Transformation Initative (CTTI), innovative approaches to quality risk 

management that make extensive use of computerised processes and in the 

management of partners will be the focus of three sessions. 


16:30 Session 0201 

TRANSPARENCY: A PANDORA’S BOX OR A PANACEA? 


Greg Koski, Associate Professor of Anesthesia, Massachusetts General Hospital 

Partners Healthcare System, USA 

19

20 

Theme 2 


Ready, Fire, Aim? An update on the ever-changing global legislation related to 

clinical trial disclosure 

Jacqueline Sayers, Quality Projects Manager, Pharma Development Quality, 

Roche Products Ltd., UK 

Limitations and Challenges of Current Registries and Results Repositories 

Frauke Naumann, Clinical Assessor, Oncology Licensing Unit, BfArM, Germany 

Transparency beyond Registries: A concept for a clinical trials commons 

Greg Koski, Associate Professor of Anesthesia, Massachusetts General Hospital 

Partners Healthcare System, USA 

Panel with Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La 

Roche AG, Switzerland 



THE PRICE OF GLOBALISATION: BRINGING MODERN THERAPIES TO 

DEVELOPING COUNTRIES OR ONLY INCLUDING PATIENTS IN TRIALS? WHAT 

SHOULD WE ALL KNOW ABOUT INDIAN SOCIETY, MEDICAL PRACTICE AND 

PATIENTS BEFORE DRAWING CONCLUSIONS? 


Shirish Dattatraya Sherlekar, Practice Head, Life Sciences, Tata Consultancy 

Services, Ltd., India 

Indian Society and Medical Care 

Shirish Dattatraya Sherlekar, Practice Head, Life Sciences, Tata Consultancy 

Services, Ltd., India 

Risk Evaluation and Mitigation Strategies - Outcome of a survey on clinical 

trials in India 

Kurt Pfister, CEO, PFC Pharma Focus AG, Switzerland 

Engaging India: Borrowing from APEC and China 

Mark Paxton, Associate Vice President, International Regulatory Affairs, PhRMA, 

USA 


THE PRICE OF GLOBALISATION: THE COSTS, BENEFITS, RISKS AND PITFALLS 

WHEN MOVING DEVELOPMENT AND MANUFACTURING TO LATIN AMERICA 


Sergio Guerrero, Director, OCA Hospital/Monterrey International Research 

Center, Mexico 

Emerging markets, such as Latin America, are now significant players in the 

global pharmaceutical industry. Economic and demographic growth has 

combined with changing disease profiles to present attractive new consumer 

markets as well as potential research and development locations. Latin America 

offers the opportunity to test on a wide variety of diseases that affect both 

developing regions as well as Western countries. As a whole, the region 

comprises 20 countries and over 560 million people, largely condensed around 

mega-cities with populations in excess of 10 or 20 million. The pharmaceutical 

and biotechnology industry has consolidated its presence in Latin America over 

the last decade, and today all the large multinational companies are reestablishing 

their presence outweighing the challenges. Emerging markets are 

unsurprisingly expected to grow at a much healthier rate, with the seven 

"pharmerging" regions of China, Brazil, Mexico, South Korea, India, Turkey and 

Russia expected to grow in importance. 

In this session we will provide you with the insight of industry experts related to 

the requirements for conducting qualified API GMP audits e.g., in India or China, 

and if this structure could be useful for the industry. On the other hand we will 

discuss the trend of the international US FDA inspections among the emerging 

markets pertaining to medical devices and device combination products, and 

where the FDA has a presence. 

Current and Future Requirements for Qualifying the GMP Compliance of API 

Manufacturers 

Stefan Kettelhoit, Managing Director, Blue Inspection Body GmbH, Germany 

The US FDA Medical Device and Device-Drug Combination Product Inspection 

Experience in Emerging Markets 

Lester B. Lacorte, FDA Medical Officer - Commissioner's Fellow, FDA, USA 

Clinical Development of New Drugs in Brazil: Opportunities and benefits 

João Massud, Executive Director/CEO, Newco Trials, Brazil 


COUNTERFEITING: WHO OWNS THE PROBLEM? WHO IS IN CONTROL? 


Yves Juillet, Senior Advisor, LEEM, France 

Drug counterfeiting is a public health threat. The EU legislative proposal as well 

as technology projects like the Data Matrix 2D pilot study is making progress. In 

this session an update of this necessary coordinated fight against counterfeiting 

will be presented. 

Counterfeiting: A necessary fight 

Silvia Fritz, International DRA Manager, F. Hoffmann-La Roche AG, Switzerland 

Update on the EU Legislative Proposal 

Christer Backman, EU Coordinator Scientific and Regulatory Strategy, Medical 

Products Agency, Sweden 

Track and Trace: The results of Data Matrix 2D pilot study in Sweden 

Jean-Marc Bobee, Director Anti-Counterfeiting Strategy, Department of 

Strategy and Information Industrial Affairs, sanofi-aventis, France 

The Role of the Pharmaceutical Industry in Tomorrow’s Coordinated Fight 

against the Counterfeiting of Medicines 

Julie Maréchal, Senior Manager, Regulatory Affairs, EGA, Belgium 


MISUSE OF MEDICINES AND DOPING: WHAT IS THE PROBLEM, HOW BIG IS 

THE PROBLEM? 


Olivier Rabin, Science Director, WADA, Canada 

Doping is considered to be the most important threat to modern sport. The 

World Anti-Doping Agency (WADA) was created by the governments of the 

world and by the sport movement to globally promote, coordinate, and monitor 

the fight against doping in sport in all its forms. Collaborations between the 

pharmaceutical industry has allowed the development of anti-doping tests and 

consequently prevented the athlete from misusing or abusing new drugs for the 

purpose of performance enhancement. The example of the successful 

collaboration between Roche and WADA for the detection of Mircera will be 

presented. Globalisation of such collaborative mechanism is being discussed 

with the industry. The public authorities are also an essential partner in the fight 

against doping in sport. The role and expectations of the public authorities will 

be presented with the particular perspective on the collaboration between the 

pharmaceutical industry and the anti-doping authorities. 

Introduction to the Problem of Doping in Sport and Society - WADA’s role 

Olivier Rabin, Science Director, World Anti-Doping Agency (WADA), Canada 

Rising to the Challenge – How a sponsor is tackling doping abuse 

Barbara Leishman, Clinical Science Leader, F. Hoffmann-La Roche AG, 

Switzerland 

Working Together in the Fight against Doping: French collaboration between 

public authorities and pharmaceutical industry, towards a European approach 

Jean-Marc Julien, Pharmacist, French Ministry for Health and Sport, France




QUALITY RISK MANAGEMENT: MYTH, PROMISE OR A SOLUTION TO THE 

OPERATIONAL CHALLENGES OF CLINICAL DEVELOPMENT AND 

REGULATORY COMPLIANCE? 



Acknowledging the costly and time-consuming quality management measures 

that sponsors, CROs, vendors and other service providers respectively take to 

reach compliance with GCP, the extent of findings, frequently identified by 

European GCP inspectors during inspections, indicate that the current approach 

to clinical quality management frequently fails to achieve the required quality 

standards. Sponsors are expected to cope with this challenge and to move 

towards a more systematic and holistic approach. This session will give an 

insight into what Health Authorities expect from risk-based quality 

management, what progress has been made by Pharmaceutical Companies 

implementing QRM and what academic sponsors think of all of this. 

Risk-Based Quality Management of Clinical Trials - An inspector view 


Risk Analysis and Risk-Based Quality Management in Non-Commercial Clinical 

Trials 

Oana Brosteanu, Coordination Centre for Clinical Trials Leipzig, Germany 

Preventing Investigator Fraud and Non-Compliance 

Kenneth A. Getz, Senior Research Fellow, Center for the Study of Drug 

Development, Tufts University; Chairman, CISCRP, USA 

Panel Discussion: What Was Accomplished and What Have We Learnt? 

Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, 

Switzerland 


NEW EFFORTS TO IMPROVE QUALITY AND EFFICIENCY IN CLINICAL 

DEVELOPMENT 


Raffael Jovine, Vice President and Global Head of Business Development and 

Head for Stakeholder Engagement, ii4sm, Switzerland 

CTTI: Challenging dogma, changing research practice 

Martin Landray, Reader in Epidemiology, Clinical Trial Service Unit, University of 

Oxford, UK 

Risk Based Contracted Services Relationship Model 

Siegfried Schmitt, Principal Consultant, PAREXEL, UK 

A New Model and Approach to Share and Leverage Compliance and Quality 

Information 

Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, 

Switzerland 

Panel discussion with Leslie Ball, Director, Division of Scientific Investigations, 

Office of Compliance, CDER FDA, USA, Gabriele Schwarz, Head, GCP Inspection 

Services, BfArM, Germany, Fergus Sweeney, Head of Compliance and 

Inspections, European Medicines Agency, EU 


GOVERNANCE CHALLENGES WHEN MANAGING PARTNERS SUCH AS CROs 

AND LICENSING PARTNERS 


Janis Little, Senior Director, Development Quality & Compliance, Genentech 

Inc., USA 

Risk-Based Contracted Services Relationship Model 

Siegfried Schmitt, Principal Consultant, PAREXEL, UK 


Pharmacovigilance in Licensing Situations 

Christine Benert, PV Contract Management, Bayer Schering Pharma AG, 

Germany 

FDA View 

David A. Lepay, Senior Advisor for Clinical Science, Science and Health 

Coordination, OC, FDA, USA 

Theme 3 

Paediatric Medicines on their Way to Patients 


Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp and Dohme 

(Europe) Inc., Belgium 

Thomas Severin, Medical Scientific Expert, Novartis Pharma AG, Switzerland 

The Paediatric Theme at the 22nd DIA EuroMeeting will reflect on opportunities 

and current challenges of paediatric drug development. The new Paediatric 

Legislation was established in Europe over 3 years ago and some early 

stocktaking can already be made: The impact of the new framework is multidimensional 

and touches on many aspects of new product development and 

lifecycle management. Regulators and Industry are discussing the adequate 

implementation of the new requirements and are negotiating Paediatric 

Investigation Plans. The overall goal is to meet the needs of children in many 

therapeutic areas whilst delivering the best possible safety protection for the 

population. Researchers and industry are collaborating to set up the necessary 

infrastructure to conduct numerous paediatric studies within a global R&D 

scope. They define new uniform standards as well as clinical and non-clinical 

methodologies to overcome the various challenges in the unique paediatric 

environment. Better and more innovative paediatric formulations are needed to 

address the selective preferences of children and enable good compliance with 

a treatment for optimal outcomes. Involvement of patent attorneys and lawyers 

is recommended for the development of a strategy to claim and achieve the 

deserved benefits in compensation for undertaking the additional research 

investments. A preliminary assessment of the positive impact on public health 

in balance with required resources will be made. 


16:30 Session 0301 

REGULATORY CHALLENGES AND EXPERIENCE WITH NEW PAEDIATRIC 

REQUIREMENTS 


Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp and Dohme 

(Europe) Inc., Belgium 

In this session experts will share their experiences with the regulatory 

requirements and their interpretations under the Paediatric Regulation. 

Participants will learn more about the European Medicines Agency Paediatric 

Committee’s (PDCO) evaluation and decision criteria related to the PIP scope to 

be able to factor those aspects into their regulatory strategy development. 

Specific case studies illustrating the challenges of regulatory input from 

different bodies, authorities and regions during the global paediatric 

development and their impact will be presented. Specifically, the impact of the 

global marketing authorisation concept for Article 8 PIPs and the access to 

incentives related to orphan drugs will be discussed. Major inconsistencies 

caused by interpretation of several provisions of the regulation and their impact 

on industry will be highlighted and constructive suggestions for improvements 

presented. 

PDCO Experience, Evaluation and Decision Criteria 

Daniel Brasseur, Chair PDCO, European Medicines Agency, EU, Senior Member, 

Federal Drug Agency, Belgium 

Challenges for Manufacturers of Orphan Medicinal and PIP Case Studies 

Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs & Scientific 

Communication, Switzerland 

21

22 

Theme 3 


Inconsistencies and Suggestions for Improvement 

Isabelle Stoeckert, Head of Regulatory Affairs Europe, Bayer Schering Pharma 

AG, Germany 



DESIGN AND CONDUCT OF ETHICAL PAEDIATRIC CLINICAL PROGRAMMES 


Sam Maldonado, Vice President and Head of the Pediatric Drug Development 

Center of Excellence, Johnson and Johnson, USA 

José Ramet, Professor, University of Antwerp, Chairman, Paediatric 

Department, Antwerp University Hospital , Belgium 

Paediatric investigation plans that meet the needs of the paediatric population, 

the regulatory environment and the commercial challenges are demanding. 

They consider quality, ethics and reliability of clinical research that are at the 

core of good paediatric development. Trial designs used for the adult 

population may include ethical and scientific issues that have to be reassessed 

to suit the paediatric perspective. Uniform standards will help to promote 

harmonised methods used for execution of such research. Paediatric networks 

may offer expert advice and support to facilitate patient enrollment and 

speeding up research to get new medicines to patients in need. 

Patient Perspectives on Ethics and Case Studies 

Speaker invited 

Standards for Research with Children (StaR Child Health) 

Hanneke van der Lee, Department Pediatric Clinical Epidemiology, Emma 

Children's Hospital Academic Medical Centre, the Netherlands 

Planning Clinical Trials in Paediatric Psychopharmacology – Results from a 

feasibility study 

Jonas Lundahl, Head of Section, H. Lundbeck A/S, Denmark 


FOCUSING ON PHARMACOVIGILANCE AND SAFETY ASPECTS OF 

PAEDIATRIC TRIALS 


Dirk Mentzer, PDCO, Head of Pharmacovigilance Unit, Paul-Ehrlich-Institut, 

Germany 

Safety of paediatric patients is the most important aspect when developing new 

paediatric medicines. Careful investigation of safety and systematic collection 

of adverse events are in the focus of researchers and regulators. Effects of new 

medicines on the developing organ system and adequate monitoring of those 

effects have to be carefully considered. Paediatric Investigational Plans usually 

require the sponsor to develop and submit a risk management plan including 

specific aspects related to the paediatric differences. 

Challenges of Safety Monitoring of Paediatric Patients 

Carlo Giaquinto, Department of Paediatrics, PENTA Foundation, Italy 

Long-term Safety Evaluations and Paediatric Pharmacovigilance 

Stephen Evans, Professor of Pharmacoepidemiology, The London School of 

Hygiene & Tropical Medicine, UK 

Integrating Requirements from PIPs into RMPs 

Janet Hormbrey, Executive Director and EUQPPV, Merck Sharpe and Dohme, 

Belgium 


PAEDIATRIC DEVELOPMENT - IS A GLOBAL STRATEGY ACHIEVABLE? 


Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, EU 

Scarce resources available for paediatrics mandate global collaboration to 

achieve the common goal of "one" global development program. This has been 

recognised by the FDA and European Medicines Agency and monthly 

exchanges and discussions have been established. The impact of those interagency 

interactions on specific paediatric development programmes will be 

highlighted. Key drivers illustrated by case studies that either facilitate or hinder 

a global development plan will be identified. This session will discuss how much 

has been achieved to date, how much is still achievable and which dreams will 

never come true. 

Global Paediatric Development - US perspective 

Ronald Portman, Director, Pediatric Development Program, Bristol-Meyers 

Squibb, USA 

Global Paediatric Development - EU perspective and case studies 

Gloria Garcia Palacios, Associate Director, Corporate Regulatory Affairs, sanofiaventis, 

France 

The Impact of New US Legislation on Paediatric Development 

Dianne Murphy, Director, Office of Pediatric Therapeutics, Office of the 

Commissioner, FDA, USA 


PAEDIATRIC FORMULATIONS - WILL THEY REACH THE MARKET? 


Gesine Bejeuhr, Senior Manager Regulatory Affairs/Quality, vfa Research-Based 

Pharm Companies, Germany 

Based on ethical principles and the unmet medical need, PDCO regularly 

requests the development of age-appropriate formulations for most medicinal 

products. In some cases this leads to additional and sometimes extensive 

innovative and technically sophisticated pharmaceutical formulation 

developments. This session will present criteria and expectations from 

Regulators related to innovative paediatric formulations and the current state of 

the discussion. Research efforts and experiences from Industry to best possibly 

respond to the paediatric demand while balancing commercial aspects will be 

shared. The viewpoint of authorities responsible for cost-effectiveness 

assessments and the potential impact on access to these new paediatric 

pharmaceutical forms will be discussed as an additional dimension. 

PDCO Expectations for Paediatric Formulations Meeting the Medical Need 

Siri Wang, PDCO, Pharmacist, Tonsberg Hospital Pharmacy, Norway 

Uncovering the Secrets of Developing Paediatric Asthma Treatment 

Fadi Eskandar, Principal Scientist, Novartis Pharma AG, Switzerland 

How do Payors Value Innovative Paediatric Formulations? 

François Meyer, Director, Health Technology Assessment Division, HAS Haute 

Autorité de Santé, France 

Panel Discussion on CHMP Draft Guideline on Pharmaceutical Development of 

Medicines for Paediatric Use with Diana Van Riet, Coordinator, Regulatory 

Affairs, RIVM, the Netherlands 



HARMONISED REGULATORY EXPECTATIONS FOR JUVENILE ANIMAL 

TESTING? 


Jacqueline Carleer, PDCO, Safety Assessor, Research and Development, Federal 

Drug Agency, Belgium 

Juvenile testing has become a critical planning issue to many early 

development projects in the EU through concerns at several levels. In this 

session, guidelines applicable to juvenile non-clinical safety testing as well as 

practical implications of the regulatory requirements will be addressed. An 

apparent drift in PDCO decisions on measures from case-by-case testing to


general screening and the reasoning for those decisions will be explained. 

Although there is a "juvenile gap" in standard toxicology programs, it is less 

clear that juvenile studies in one or two species would be sufficient to reliably 

screen for unexpected adverse effects on several organs related to humans. A 

critical analysis of existence and usefulness of juvenile animal studies for all 

medicines approved for children via the EU centralised procedure (before the 

Paediatric Regulation 1995-2005) and data requested from those studies for 

medicines in all approved PIPs (2007-2009), may provide a better 

understanding of the current evolution of the debate regarding the necessity 

for those studies and the relevance of findings. 

Juvenile Non-Clinical Animal Testing in the Development of Paediatric 

Products: Regulatory requirements and practical implications 

Marianne Groeneveld, Senior Regulatory Affairs Manager Pharma, TNO Quality 

of Life, The Netherlands 

Juvenile Animal Studies: When, why, and what are you going to do with the 

data? 

Anders Neil, Principal Consultant, PAREXEL, UK 

Juvenile Animal Studies in the Development of Paediatric Medicines: Learning 

with 10 years’ experience of centralised procedure and Paediatric 

Investigation Plans 

Dinah Duarte, Regulatory and Scientific Affairs Manager, INFARMED, Portugal 

Panel with speakers and FDA speaker 


CHALLENGES UNDER THE PAEDIATRIC REGULATION TO OBTAINING THE SPC 

EXTENSION 


Geneviève Michaux, of Counsel, Convington & Burling, Belgium 

Industry is investing a substantial amount of additional research budgets to 

meet the needs of children and comply with new requirements to conduct 

paediatric development programs for most of their medicinal products. 

Although a specific timing challenge for obtaining the deserved rewards exists 

for already-marketed products, even new products with relatively long patent 

lives can face challenges considering the staggered safety approach of clinical 

investigations in various age groups over a longer period of time. In addition, 

administrative processes may consume relatively long time periods which may 

be better used for conducting the paediatric programmes. Even after 

demonstrating full compliance with approved PIPs, inconsistencies in the 

Paediatric and SPC Regulations and strict interpretation of legal requirements 

provide additional hurdles for obtaining the rewards under the new system. 

Explaining sometimes complex regulatory processes relevant for the 

application of the SPC Regulation at national level is sometimes challenging. 

Experiences and reasoning of national patent offices for their decisions will be 

presented and explained. 

Legal Update after 3 Years Experience with the Paediatric Regulation 

Chris Foreman, Director, Legal Affairs, Scandinavia Region, Merck Sharpe and 

Dohme, Belgium 

European Commission Perspective 

Commission speaker invited 

French National Patent Office Perspective 



INITIAL IMPACT OF THE PAEDIATRIC REGULATION AFTER 3 YEARS 


Thomas Severin, Medical Scientific Expert, Novartis Pharma AG, Switzerland 

The EU Paediatric Regulation is now in force for more than 3 years. However, its 

impacts on various stakeholders are still unfolding. A first analysis, impact 

assessment and conclusions by CROs, industry and regulators will be presented 


in this session. It has to be investigated if the stated objective of the Regulation 

to enhance availability of medicines for the paediatric population has been 

achieved and whether the requirements are proportionate. 

Results of the European CRO Federations Surveys on the State of Paediatric 

Research in Europe 

Philippa Smit-Marshall, Vice President Medical and Scientific Affairs, 

PharmaNet, UK 

Impact on Industry - Resources for paediatric drug development 

Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services, 

Germany 

Impact on Regulators - European Medicines Agency, PDCO and national 

agency collaboration 

Agnès Saint Raymond, Head of Human Medicines Special Areas, European 


Theme 4 

Decision Making: The Key to Efficient and Effective Drug 

Development, Approval and Access 


Craig Johnson, Principal Regulatory Consultant, Regulatory Information & 

External Affairs, Eli Lilly, UK 

Tomas Salmonson, Vice Chairman, CHMP, European Medicines Agency, MPA, 

Sweden 

Effective “decision making” is essential for innovative medicinal products to be 

made available to patients. During the last decade, new stakeholders have 

emerged who are influencing which product may finally be taken by an 

individual patient. Company strategies, regulatory approvals, assessments by 

HTA bodies, international and national treatment recommendations, local drug 

committees, opinion leaders, treating physicians and, in the end, the (informed) 

patient may influence choice of treatment. 

Decision making by all these stakeholders is complex and subjective by nature. 

Regulatory bodies strive to make their assessment of the benefit/risk of new 

product valuable tools for other parties, not least of which are the increasingly 

prominent HTA bodies. However, this aim, while laudable from an efficiency 

point of view, can only be fully achieved by building trust through adequate and 

appropriate transparency. Hence, there needs to be a description of the decision 

making clear enough to allow the reader to agree or disagree with the decision, 

and to understand the applicability of that decision in the context of their own 

decision making. Correspondingly, this increasingly complex environment 

demands that pharmaceutical companies make critical decisions on the most 

efficient and effective drug development programme to meet both regulatory 

and HTA needs. 

The aims of this theme are to examine these elements and consider the ways in 

which decision-making processes may need to change in response. Ways to 

approach benefit/risk decisions and increased transparency in this process will 

be discussed both from an industry and regulatory/health care provider aspect. 

Various specific aspects of pre-and post-approval decisions will be debated. 


16:30 Session 0401/1001 

PATIENT INFLUENCE ON REGULATORY DECISIONS: HOW MUCH DO THEY 

AND SHOULD THEY HAVE? (JOINT SESSION WITH THEME 10) 


Frits Lekkerkerker, Member NDA Advisory Board, NDA Regulatory Science Ltd., 

UK 

Patient organisations are increasingly involved in the activities of the European 

Medicines Agency, but how much influence do they (and should they) have? 

This session will consider the views of various stakeholders on the involvement 

of patients in the work of the European Medicines Agency and its scientific 

23

24 

Theme 4 


committees, as they make regulatory decisions in product assessment and on 

guideline development, etc. The inclusion of patients’ perspectives in decisions 

on benefit/risk assessments will be discussed, as will the balance that needs to 

be met between those decisions and patients’ subsequent treatment choices. 

How Much Influence Do and Should Patients Have on Regulatory Decisions? 

Alistair Kent, Director, Genetic Interest Group, UK 

Are Patients’ Perspectives Heard and How Can They Be Captured in 

Benefit/Risk Decisions? 

Jeremiah Mwangi, Senior Policy Officer, International Alliance of Patients’ 

Organisations (IAPO), UK (TBC) 

How Can the Right Balance be Struck between Regulators’ Decisions and 

Patients’ Choices? 

Patrick Salmon, CHMP, European Medicines Agency, Senior Medical Assessor, 

Irish Medicines Board, Ireland 

Panel with Isabelle Moulon, Head of Medical Information, European Medicines 

Agency, EU 



TRANSPARENCY AND RELATED SAFEGUARDS 


Anne N. Nielsen, Vice President and Senior Counsel, Europe and Asia Pacific, 

Bristol-Meyers Squibb, USA 

This session will include an in-depth discussion on how to ensure transparency, 

but at the same time consider complementary safeguards. Is there a process 

that could be put in place so that any concerns about how information might be 

used could be communicated to the relevant authorities? Under what 

circumstances could or should such a dialogue take place? Could or should a 

process that focuses on safeguards be implemented? If so, what might such a 

process look like? I believe that an exchange of views on this subject would 

provide a platform to further understand whether safeguards are needed, and 

if so, what they would look like and how they would operate. 

Aginus Kalis, Director General, Medicines Evaluation Board, The Netherlands 

European Medicines Agency Perspective 

Valentina Stamouli, Scientific Administrator, Regulatory Affairs, European 


EFPIA Perspective 

Christine-Lise Julou, Director, Scientific Technical and Regulatory Affairs, EFPIA, 

Belgium 

Panel with National Authority to be confirmed 


CONDITIONAL APPROVALS: HOW TO STRIKE THE RIGHT BALANCE 

BETWEEN EARLY ACCESS, PATIENT SAFETY AND COMMERCIAL REALITY 


Michael Doherty, Global Head, Pharma Regulatory Affairs, F. Hoffman-La Roche 

AG, Switzerland 

The intent of this session is to discuss various challenges with the granting of 

conditional marketing authorisations, and the decisions associated with those 

challenges. When should conditional approvals be used - for all products, or 

only for breakthrough or life-saving products? Do conditional approvals really 

facilitate early access, or do they just lead to more post-approval commitments? 

Does a restricted label and/or extensive post-approval commitment have a 

negative effect on HTA decisions and, if so, would reduced access prevent 

enough data ever being generated to make the product “unconditional”? 

Clare McGrath, Senior Director HTA Policy Europe/ROWD, Pfizer Ltd., UK 

Robert Hemmings, Statistics Unit Manager, MHRA, UK 

Alison Harrison, Vice President, European Regulatory Affairs, AstraZeneca, UK 

Session under development. 


CLINICAL TRIALS: THE DEMISE OF TRADITIONAL SURROGATE MARKERS? 

HOW TO CREATE NEW MARKERS? 


Spiros Vamvakas, Head of Scientific Advice, Technical Coordinator for ICH, 


This session will discuss regulatory pathways for the development of 

biomarkers and other novel methodologies in the European environment. It will 

also address the novel public-private partnerships both in the EU (Innovative 

Medicines Initiative, IMI) and in the US (C-Path) and the collaboration between 

industry and regulators in the development of new tools. 

Progress and Experience with IMI/C-Path 

Solange Corriol Rohou, Director, Regulatory Affairs, AstraZeneca, France 

How Best to Identify and Develop New Biomarkers 

Maria Isaac, Scientific Administrator, European Medicines Agency, EU 

CSF Biomarkers for Identification of Prodromal Alzheimer's Disease Patients 

Charles Albright, Group Director, Neuroscience Biology, Bristol-Myers Squibb, 

USA 


THE TRUE VALUE OF RISK MANAGEMENT FOR DECISION MAKING AND FOR 

POST-APPROVAL COMMITMENTS 


Valerie Simmons, EU QPPV Executive, Global Patient Safety, Eli Lilly and 

Company Ltd., UK 

The requirement for effective risk management systems in Europe has now 

been in place since 2005. Whilst all stakeholders intuitively agree that risk 

management principles are the right way forward for optimising benefit risk, 

the question remains, have all the activities and efforts invested by all 

stakeholders in the interim period actually provided true value for patients in 

mitigating risks and promoting public health? This session will examine these 

questions from the viewpoint of multiple stakeholders. 

Effectiveness of Risk Minimisation Plans - Has this actually led to tangible 

patient outcomes? An Industry perspective 

Steve Hobbiger, Vice President, Neurosciences and EU QPPV, Global Clinical 

Safety and Pharmacovigilance, GlaxoSmithKline, UK 

Has the Experience of Risk Minimisation Plans led to Changes in Regulatory 

Expectations or Requirements to Promote Effectiveness? 

Stella Blackburn, Scientific Administrator, Pharmacovigilance and Risk 


What are the Costs of Fulfilling Risk Management Commitments and are They 

Justified? A view from the prescriber operating in the new risk management 

environment 

Debra Szafir, Head Safety Risk Management Strategy, Roche, France 



THE BENEFIT/RISK ASSESSMENT OF MEDICINES IN THE APPROVAL 

PROCESS: DEVELOPING A STRUCTURED APPROACH TO DECISION MAKING?



Stuart Walker, Founder, CMR International Institute for Regulatory Science, UK 

Measuring the benefits and risks of medicines is the underlying theme in the 

development, review and regulation of medicines, but over the last five years 

the environment for developing medicines has become increasingly risk 

adverse. 

Agencies and companies are each developing their own viewpoint on what are 

appropriate frameworks for assessing benefit/risk. There is a need to encourage 

an environment in which a more balanced view of risks and benefits is taken. 

Important progress has been made in the methodology used to assess 

benefit/risk in the development and review of new medicines but there is a 

great deal yet to be achieved. In this session, the views of agencies on a 

framework for benefit/risk will be presented as well as what value parameters 

are being utilised, how the information can be used to manage risk and how can 

agencies share best practice. 

What Are the Issues to Be Addressed? 

Stuart Walker, Founder, CMR International Institute for Regulatory Science, UK 

A Systematic Approach to Decision Making – An FDA viewpoint 

FDA speaker invited 

How the European Medicines Agency Plans to Develop a Structured 

Framework for Benefit/Risk Assessment 

Xavier Luria, Head of Sector Safety and Efficacy of Medicines, European 

Medicines Agency , EU 

A Collaborative Pilot Study to Improve the Benefit/Risk Assessment of 

Medicines by Health Canada, Therapeutic Goods Administration, Australia; 

Health Sciences Authority, Singapore and Swissmedic 

Petra Dörr, Head of Management Services and Networking, Swissmedic, 

Switzerland 

11:00 Session 0407/0807 

INFLUENCE OF HTA ON REGULATORY DECISION MAKING: REALITY? AN 

OPPORTUNITY? A THREAT? (JOINT SESSION WITH THEME 8) 




European Medicines Agency perspective 

Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU 

Getting to the Right Evidence for Licensing and HTA Authorities at the Point 

of Launch: An achievable endpoint? 

Franz Pichler, Portfolio Manager, CMR International Institute for Regulatory 

Science, UK 


COMPANY DECISION MAKING DURING DRUG DEVELOPMENT 


Jacques Mascaro, Senior Vice President, Global Regulatory Affairs, 

Pharmacovigilance and Quality, Elan Pharma International Ltd., Ireland 

The session will integrate a strategic review of decision making during drug 

development and registration. The importance of early global regulatory and 

safety strategies for decision making in development and filing will be 

discussed: What elements need to be taken into account? How can new tools, 

such as modelling, be best used in decision making during development? How 

does their use impact the decisions made later by the “gatekeepers” for access 

(regulators and HTAs)? How do companies ensure optimal drug development 

to satisfy both regulators and HTAs? 

Adequate and Well-Controlled Confirmatory Clinical Trials with Adaptive 

Design Reflections about Similarities and Options in Two Regulatory 

Guidance documents 

FDA Perspective 


Theme 5 

Quantitative Approaches to Decision Theory and Scenario Evaluation 


The Integrated Drug Development and Regulatory Strategies – From TPP to 

Risk Management: The industry view on the importance of early global 

development, regulatory and safety strategies 

Stephanie Krumholz, Associate Director, GRL Taspoglutide, Pharma 

Development Regulatory, Hoffmann-La Roche Inc., USA 

Theme 5 

Paving the Way for Advanced Therapies - Fostering new 

generations of biotechnology-derived medicines 


Catarina Edfjäll, Senior Director, Regulatory Affairs Europe, Celgene 

International SARL, Switzerland 

Patrick Celis, Scientific Administrator, Scientific Committee Support, European 


From recombinant therapeutic proteins and monoclonal antibodies, to 

advanced therapies like cell-based and gene therapy medicinal products, each 

new generation of biotechnology-derived medicines comes with great 

opportunities and interesting challenges. In Europe, the Advanced Therapies 

(ATMP) legislation was implemented in December 2008 and it has brought a 

new Committee for Advanced Therapies (CAT) and novel regulatory procedures 

for advanced therapies to the European Medicines Agency. Additionally, 

biosimilars have been evaluated and regulated in Europe for a few years now, 

as several biosimilar recombinant therapeutic proteins have been approved and 

are being commercialised in Europe. 

The theme will address the opportunities and challenges raised by today’s 

innovative breakthroughs using new biotechnology platforms and novel 

treatment approaches. This theme will specifically discuss how the evolving 

regulatory environment impacts on companies working in this cutting-edge 

research area and on regulators performing the assessment of such products, 

which sometimes come with highly specific requirements. The experience in the 

first year of the ATMP legislation and the CAT will be reported, as we get closer 

to seeing new advanced therapies available to patients. Specific case studies 

and examples will be shared. Borderline areas in the legislation around medical 

devices and combination products will also be examined. 

Biotechnology-derived medicines have opened and will continue to open up 

huge treatment opportunities for patients, and we need to understand if the 

complexity of new generation medicinal products could impact the 

responsibilities of healthcare professionals and requirements for risk 

management plans. 


16:30 Session 0501 

CAT EXPERIENCE IN THE FIRST YEAR 


Christian Schneider, Chair CAT, European Medicines Agency, Head, Division EU 

Cooperation/Microbiology, Paul-Ehrlich-Institut, Germany 



The Committee for Advanced Therapies (CAT) is operational from January 

2009 onwards. In this session, the functioning and experience to date will be 

presented of the work of the CAT on the evaluation of marketing authorisation 

applications for advanced therapy products, on scientific advices, certification 

and classification procedures. Industry's initial experience with the new 

procedures and the interactions between applicants and CAT will be discussed. 

Experience from CAT 



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Theme 5 


Interactions with Applicants Developing ATMPs and New Procedures 



The New Certification Procedure for Quality and Pre-clinical Data for SME: 

What does it look like and what are the first results? 

Matthias Wilken, Head of Drug Regulatory Affairs Europe, German 

Pharmaceutical Industry Association (BPI), Germany 



ATMP BORDERLINES 


Burkhard Sträter, Lawyer, Kanzlei Sträter, Germany 

This session will highlight the borderlines between surgery in hospital and 

manufacturing and application of ATMPs, and discuss the relevance of hospital 

exemptions. It is becoming a challenge to find the right balance between 

legitimate interest in driving research forward into uncharted territory and the 

need for regulatory requirements and control of such products. Various relevant 

questions will be addressed: At what point does a cell or tissue taken from a 

patient turn into a medicinal product? What is the regulatory impact for 

research with regards to product distribution, or the need for a CTA and MA 

prior to applying the treatment? To what extent does the hospital exemption 

Art 28 of the ATMP regulation apply? Bedside therapies require the use of 

medical devices, including any ATMPs. This creates a new type of products 

which combine an ATMP and medical device. Do these products therefore have 

different regulatory requirements? 

Borderlines in Legislation on ATMP and Medical Devices - Relevance of 

hospital exemption for ATMPs 

Burkhard Sträter, Lawyer, Kanzlei Sträter, Germany 

Interaction CAT - Notified Bodies 

Marie-Hélène Pinheiro, Scientific Administrator, Regulatory Affairs, European 


Advanced Therapy Regulation: What products are excluded? 

Geneviève Michaux, Of Counsel, Covington & Burling LLP, Belgium 


ATMPS AND BIOTHERAPEUTICS – DO THEY REQUIRE CHANGES TO 

ESTABLISHED QUALITY AND MANUFACTURING CONCEPTS? 


Lothar Hartmann, Head of External Relations, F. Hoffmann-La Roche AG, 

Switzerland and Chair, Biomanufacturing Group, European Biopharmaceuticals 

Enterprises (EBE) 

The manufacture of advanced therapy medicinal products and biotherapeutics 

poses particular challenges. This session will focus on the implications of a riskbased 

approach and will address buildings, facilities and equipment; materials 

management; production, in-process controls and testing; GMP requirements 

during development. 

The Regulatory Perspective on the Risk-Based Approach and the Differences 

between Cell-Based Products and other Biologicals 

Paula Salmikangas, Vice Chair, CAT, European Medicines Agency; Associate 

Professor, University of Helsinki, Senior Researcher, National Agency for 

Medicines, Finland 

Developing Advanced Therapy Medicinal Products for Global Market – One 

system fits all? 

Karin Hoogendoorn, Regulatory Affairs Manager - CMC, Contocor, 


Constraints for an SME Entering the Global Market 

Gemma Fernández, Technical Director (Qualified Person), Cellerix, Spain 


IMPACT OF NEW THERAPIES ON PRE-CLINICAL RESEARCH 


Beatriz Silva-Lima, CHMP, European Medicines Agency; Professor, 

Pharmacology, University of Lisbon, INFARMED, Portugal 

Is the development of advanced therapies creating new paradigms or adapting 

existing paradigms to the new concepts of non-clinical research? Which are the 

regulatory/scientific challenges raised by the implementation of the 

certification procedure? ICH S10? 

European Regulatory View and Experience 

Beatriz Silva-Lima, CHMP, European Medicines Agency; Professor, 

Pharmacology, University of Lisbon, INFARMED, Portugal 

The Regulatory and Scientific Experience in the US: FDA View 


From Bench to Bedside: Challenges in bringing novel cell-based therapies 

from experimental studies into successful clinical programmes 

Marga Oortgiesen, Vice President, Drug Development, Cato Research Ltd., USA 


CLINICAL RESEARCH: NEW THERAPIES - NEW CHALLENGES 


Detlef Niese, Head, Development External Affairs, Novartis, Switzerland 

Katrin Rupalla, Director, Regulatory Affairs, Celgene International SARL, 

Switzerland 

Can current clinical trial rules cope with cell- and gene-treatments? How to 

factor the surgical aspect of advanced therapies into the development process? 

Ethical aspects of clinical development? 

Experiences with Scientific Advice and Small Enterprises: Hopes and reality 

Zaklina Buljovcic, Head of Special Medicinal Products, Medical Devices and 

Borderline Products, Pharmalex GmbH, Germany 

Submission of an IMPD for a Multicentre Clinical Trial with an ex vivo Gene 

Therapy Product 

Didier Caizergues, Head of International Regulatory Affairs, Genethon, France 

The Role of the CAT in Scientific Advice and Classification of ATMPs 





BIOSIMILARS - FUTURE DEVELOPMENTS AND REGULATORY CHALLENGES 


Emmanuel Chantelot, Executive Director, European Biopharmaceutical 

Enterprises (EBE), Belgium 

Falk Ehmann, Scientific Administrator, Human Unit, Anti-infectives, Scientific 

Secretary of BMWP, European Medicines Agency 

This session focuses on challenges in the regulation and commercialisation of 

biosimilars products in the European Union while exploring new biosimilar 

territories in the world of biotherapeutics. 

Challenges in the Regulation of Biosimilars and Perspectives of the CHMP 

Working Party on Similar Biological Medicinal Products (BMWP) 

Falk Ehmann, Scientific Administrator, Human Unit, Anti-infectives, Scientific 

Secretary of BMWP, European Medicines Agency


Lessons Learnt from the First Biosimilars and Challenges for the Future 

Maria Saurwein-Teissl, Head Regulatory Affairs Group Biopharmaceuticals, 

Sandoz, Austria 

Perspectives on the National Experience with Biosimilars in Germany 

Wolf-Dieter Ludwig, Professor of Hematology and Oncology, Head of 

Department of Hematology, Oncology and Tumor Immunology, Robert-Rössle 

Clinic, HELIOS Clinic Berlin-Buch, Germany 


ADVANCED THERAPIES AND MEDICAL DEVICES – LIVING WITH A NEW RISK 

MANAGEMENT REALITY? 


Ingemar Persson, Senior Assessor, MPA, Sweden 

Pharmacovigilance and Risk Management plans – Do Advanced Therapies 

create specific challenges? Training and education of healthcare providers? 

The benefit/risk balance: is it manageable? Or should we be happy with risk 

control? This session will look at traceable requirements for ATMPs. 

What is different for ATMPs? 

Jan Petracek, Head of Risk Management, European Medicines Agency, EU 

Regulator’s View 

Ingemar Persson, Senior Assessor, MPA, Sweden 

Industry Experience with RMP for an Approved ATMP 



HEALTH TECHNOLOGY ASSESSMENTS - ARE THEY POSSIBLE FOR 

ADVANCED THERAPIES? 


Carolin Miltenburger, Director, HEOR, i3 Innovus, Germany 

EU institutions have agreed on regulation on advanced therapies designed to 

ensure access to products within Europe. How will HTA look like and what are 

the success factors for attaining reimbursement? Can the same methods and 

principles be used which are now established for other therapies in Europe? 

Added Value in ATMP and Devices – Strategies for market success 

Kathy Cargill, Vice President, Reimbursement and Health Economics, 

International, Medtronic, Switzerland 

Is There a Role for QALY? Assessing cost effectiveness of therapy in PD 

Ulf Persson, Professor, Swedish Institute for Health Economics (IHE), Sweden 

Managing and Monitoring the Appropriate Use of Advanced Therapies: The 

Anticancer Innovative Medicines Register of the Italian Medicines Agency 

Luca De Nigro, Project Manager, Italian Medicines Agency, Italy 

Theme 6 

Challenges for Switching from Prescription to Non- 

Prescription Status through the Centralised Procedure 


Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, 

Belgium 

Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU 

With Regulation (EC) Nï 726/2004, the centralised procedure became a new 

route for the change of legal status of medicines hence allowing their access as 

a non-prescription medicine across the EU at once. This is breaking new 

grounds for industry, the European Medicines Agency and national authorities, 

generating new opportunities but also challenges and question marks. Taking 

the views of regulators, industry, healthcare professionals and 

patients/consumers, the theme will reflect on both the experience accumulated 

so far and on future trends. The impact on national markets and national 

attitudes will also be an important and interesting question for debate. Ensuring 

that the patients/consumers get the right level of information is paramount in 

the self-care context and this may bring new questions and challenges when 

discussed at the EU level. Lastly, will the centralised procedure give a new 

chance to well established molecules and/or its combinations? Ultimately, will 

the centralised procedure, coupled with incentives and better regulation 

principles, contribute to boost the competitiveness of the European self-care 

sector? 


16:30 Session 0601/0901 

RISK MANAGEMENT FOR SWITCH PRODUCTS 

(JOINT SESSION WITH THEME 9) 


Andrew Rut, Vice President, Global Clinical Safety and Pharmacovigilance, 


This session will cover the challenges of taking prescription products to overthe-counter 

use at the European level and how these can be addressed with 

creative pharmacovigilance and risk management approaches. There is an 

increasing desire for making medicines available without a prescription and for 

patients to take greater responsibility for their health. The criteria that define a 

successful OTC switch will be discussed using data collected across key 

pharma/consumer companies, from a case study and from the perspectives of 

the European Regulatory Authorities. 

Current and Optimal Approaches, Including Industry Perspectives for 

Innovative Switches 

Chris Holmes, Director, World Class International, UK 

A Case Study of Risk Management Planning for a Novel Switch: Orlistat 



Regulatory Expectations of Risk Management Programmes for Innovative 

Switches 




ARE THE INCENTIVES PROVIDED IN LEGISLATION SUFFICIENT TO BOOST 

INNOVATION AT THE EU LEVEL? 


Hubertus Cranz, Director-General, AESGP, Belgium 

Significant studies backing the change of legal status may benefit from 

protection in the EU for one year. In the USA, they benefit from three years. 

Compared to the US situation, are EU incentives considered sufficient for 

companies to invest in research and to put on the market more innovative 

switches? In addition, initiatives aiming at decreasing red tape and regulatory 

burden may, by freeing up resources, contribute to boost innovation and 

growth. 

View of the Industry 


Theme 6 

Better Regulation in the UK: A governmental priority 

Chris Horsey, Head, Better Regulation, Department of Health, UK 

Incentives and Better Regulation in the US 

Andrew Fish, Senior Vice President, Legal and Government Affairs, General 

Counsel and Secretary CHPA, USA 

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28 




SWITCHING TRENDS: EVOLUTION OR REVOLUTION? 


Tomas Salmonson, Vice Chairman, CHMP, European Medicines Agency; MPA, 

Sweden 

Since the review, major changes have occurred in the self-care arena both in 

terms of new filing authorisation routes, new classes of molecules being 

switched (e.g., triptans in case of migraine, simvastatine in the UK), as well as 

the regulatory environment taking non-prescription medicines increasingly into 

account. A shift in self-care treatments from minor ailments to more chronic 

conditions can also be noted in some EU countries. Is this a phenomenon or 

simply the result of a slow evolution? Discussion will take place on the likelihood 

of the following therapeutic areas to become available in self-care and/or 

collaborative care: allergic conjunctivitis, urinary incontinence and insomnia. 

Challenging Switches: Experiences of a member state 

Shirley Norton, Deputy Director, Vigilance and Risk Management Division, 

MHRA, UK 

New Directions for Switching: Possible examples including: preventive health; 

insomnia; urinary tract and ophthalmic diseases 

Stephen Mann, Director, The Mann Consultancy, UK 

Is There Really a Trend behind Switch Decisions? 

Bernd Eberwein, Managing Director, BAH, Germany 


“CENTRAL SWITCHES” – WHERE ARE WE GOING? 


Hubertus Cranz, Director-General, AESGP, Belgium 

Since Regulation (EC) Nï 726/2004 opened the door of the centralised 

procedure to non-prescription medicines, a few applications have pioneered 

and succeeded in this new route for a change of legal status from Rx to non-Rx. 

This session will address key steps and fundamental notions of the procedure 

such as eligibility, legal basis, switch criteria, role of invented names, pack 

design, etc. Lessons learnt on the first experiences will be shared and insights 

provided as to appropriate regulatory strategies. Authorities and industry will 

give their views on this new route, how it can be optimised and what may come 

next in terms of applications and/or opportunities. 

The CHMP Viewpoint 

Eric Abadie, Chairman, CHMP, European Medicines Agency; General Directorate, 

Afssaps, France 

Industry View 

Etienne de la Rouillère, Vice President, Head of Global BU OTC, Nycomed 

International Management GmbH, Switzerland 


COULD THE UK MODEL BE REPRODUCED AT THE EU LEVEL? 


Anthony Humphreys, Head of Regulatory, Procedural and Committee Support, 


Similarly to the non-prescription legal status, the attitudes towards self-care are 

not harmonised across the EU. Beyond the switch criteria and the intrinsic 

properties of the medicine, many other factors indeed impact on the decision 

to switch. Medical culture, healthcare systems and notion of risks are some of 

them. Could discussions at the central level contribute to expand/harmonise 

such attitudes for the whole of Europe. Consumers, patients and authorities will 

provide their views. 

The Consumer’s Perspective 

Ilaria Passarani, Health Policy Officer, The European Consumers' Organisation 

(BEUC), Belgium 

The Health Services: A no-man’s land? Men’s Use of Health Services in Europe 

Ian Banks, President, Men’s Health Forum, UK 

Industry’s Point of View 




IMPACT OF THE EU DECISION ON NON-PRESCRIPTION STATUS AT THE 

NATIONAL LEVEL 


Bernd Eberwein, Managing Director, Science, BAH, Germany 

On 13 May 2009, DG Enterprise and Industry issued a note setting out its 

interpretation on a number of issues related to prescription and nonprescription 

medicines and the use of the centralised procedure, e.g., whether 

the same medicinal product can have a dual status of both prescription and 

non-prescription, under which circumstances central and national marketing 

authorisations can/cannot co-exist, possibly with different prescription status 

and how potential conflict between central and national marketing 

authorisations would be addressed. It derives, for example, that centrally 

approved medicines should be switched using the centralised route. Such note 

could bear important consequences on the market, including for generic 

medicines. In this session, the Commission, industry and a national competent 

authority will provide their perspective on the note and its potential 

consequences from a legal, regulatory or commercial angle. 

Impact of Community Decisions on Prescription Status at the National Level: 

The legal perspective 

Rocio Salvador Roldan, Policy Officer, European Commission, EU 

EGA View 

Beata Stepniewska, Director of Regulatory Affairs, EGA, Belgium 

Ministry View 

Anna Dwenger, German Ministry of Health (BMG), Germany 


INFORMATION TO PATIENTS/CONSUMERS: FIT FOR PURPOSE? 


Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU 

Ensuring that patients get the right information is critical. It is even more so in 

the context of non-prescription medicines as the patient/consumer is not 

necessarily under the supervision of the doctor. Package leaflet, website, 

pharmacists, invented name and pack design, all have a role to play in 

conveying the right information to the patient/consumer. As education tools, 

they also empower citizens to make their own decisions concerning their health. 

Is information adequate, sufficient and accessible? Is information adapted to 

the context of self-care? How does the current regulatory framework provide 

for that? Does it change the role of the pharmacist? 

Competent authority, industry and pharmacists will debate this critical topic. 

How to Meet the Patient's Needs with the Available Information Tools 

Isabelle Moulon, Head of Medical Information, European Medicines Agency, EU 

OTC Medicines Information Needs - What, where, when and how 

Helen Darracott, Director of Legal & Regulatory Affairs, PAGB, UK 

The Pharmacist’s Role in the Age of the “Informed Patient” 

John Chave, Secretary General, Pharmaceutical Group of the European Union, 

PGEU, Belgium



NEW CHANCE FOR WELL-KNOWN SUBSTANCES: CP OR MRP/DCP 


Truus Janse-de Hoog, Staff Member MEB, European Cluster, Chair CMD(h), 


Products which have been in well established medicinal use within the EU for at 

least 10 years are eligible for bibliographic applications where results of preclinical 

tests and clinical trials can be replaced by literature. Those medicines 

have a well-known safety profile. The session will review the challenges 

encountered in relation to acceptance of bibliographic applications for wellknown 

substances. To which extent can they represent interest to patients at 

community level (IPCL) and be eligible for the central route? What type of 

issues may arise in a DCP/MRP? What’s new for fixed combinations of wellknown 

substances? 

Increasing Regulatory Requirements Restrict the Growth of the OTC Market 

Annemarie Jasper, Business Development, Diapharm, Germany 

Herbal Medicinal Products on their Way from Mutual Recognition to a 

Centralised Procedure – One small step, or one giant leap? 

Emiel van Galen, Head of Section, Medicines Evaluation Board, The Netherlands 

Panel with Anthony Humphreys, Head of Regulatory, Procedural and Committee 

Support, European Medicines Agency, EU 

Theme 7 

Personalised Medicines 


Wills Hughes-Wilson, Director, Health Policy Europe, Genzyme, Belgium 

Marisa Papaluca Amati, Head of Scientific Support and Projects, European 


Personalised medicines is an increasingly “hot topic” – but whether it is seen as 

a threat, an opportunity or the very essence of the future (bio)pharmaceutical 

industry depends largely on who you are talking to. This theme will outline what 

personalised medicine and targeted therapies mean in reality and will explore 

how the field can be developed to its full potential. Several regulatory agencies 

have taken steps to address the emerging possibilities to target therapies either 

during or after development, to reduce side effects and increase effectiveness. 

Where we go from here and what happens next will largely determine if this 

field develops or remains a complicated niche. The theme will build on 

experience to date, learning from the existing diagnostic and therapy 

relationships. It will examine regulators’ points of view from different 

geographic locations and explore the attitudes of other stakeholders in the 

healthcare field, be they patients, industry, payers or physicians. It will explore 

what steps need to be taken to achieve a successful marketing authorisation for 

a diagnostic-and-drug combination and what needs to be done to support and 

encourage the fields that will be crucial to the success or otherwise of this field, 

including diagnostics and IT systems. And finally, participants will discuss how 

we will handle the data that is gathered: what intellectual property and privacy 

issues might be created and how can we address them? Representatives from 

all aspects of the growing and inter-disciplinary personalised medicines field 

will participate in this theme, with the objective of advancing the debate and 

bringing clarity in where we stand and where we need to go from here. 


16:30 Session 0701 

PERSONALISED MEDICINES: WHAT IS IT, WHERE DO WE STAND AND WHERE 

ARE WE GOING? 


Marisa Papaluca Amati, Head of Scientific Support and Projects, European 


What are we talking about? What are the successes to date? What are the 

Theme 7 

challenges to date? Why should we keep on moving forward? 

Genomics Approaches to Biomarker Development and Contribution to 

Personalised Cancer Therapeurics: A practical view from the field 

Charles Swanton, MRC/CRUK Group Leader, Translational Cancer Therapeutics 

Laboratory, Cancer Research, UK 

Driving Personalised Medicine: Financial metrics to ensure maximum NVP and 

optimal ROI 

Mollie Roth, Corporate Counsel, Vice President, Business Development, 

Diaceutics, USA 

What Is Needed for the Health Technology Assessor? 


Panel with James Creeden, Head of Medical Affairs, Roche Diagnostics Ltd, 

Switzerland 



IS EUROPE ADAPTED TO PERSONALISED MEDICINES? WHAT NEEDS TO 

CHANGE OVER THE NEXT 10 YEARS? 


Eric Abadie, Chair, CHMP, European Medicines Agency; General Directorate, 


As personalised medicines become a reality, they need to be supported in the 

European context, so that they can be used to their full potential. This session 

will explore whether Europe is ready for personalised medicines and whether 

changes are required to take advantage of the benefits they will provide. 

Speakers will also put forward solutions to the challenges faced, to be discussed 

with the audience. 

The Challenges for Industry 

Bob Clay, Vice President, Regulatory Affairs Oncology and Infection, 


Personalised Medicines and Clinical Practice: Challenges and opportunities 

Munir Pirmohamed, Professor, Department of Pharmacology, University of 

Liverpool, UK 

What is Required by Patients? 

Mary Baker, MBE, President of European Federation of Neurological 

Associations (EFNA), UK 


ONE MEDICINE DOES NOT FIT ALL. WHAT HAS WORKED AND WHAT CAN 

WE LEARN? 


Andrea Rappagliosi, Vice President European Government Affairs and Head of 

Brussels Office, GlaxoSmithKline, UK 

This session will bring together three companies with very different business 

models in the field of personalised medicines, with the objective of examining 

the elements of potential business strategies that have been successful in the 

field. 

Talking from Experience 

Bill Pignato, Head of Regulatory Affairs, Novartis Molecular Diagnostics, USA 

Vectibix: A new treatment paradigm? 

Alan Morrison, Vice President, International Regulatory Affairs and Safety, 

Amgen, UK 

IRESSA, the Last Piece of the Puzzle! 

Anne De Bock, Portfolio Leader Oncology & Anti-infectives, AstraZeneca, 

Belgium 

29

30 



BIOMARKER QUALIFICATION PROCESS - HOW DOES IT WORK AND WHERE 

DOES IT FIT? 



The European Medicines Agency’s new procedure on biomarker qualification is 

a crucial new element in supporting the development of personalised 

medicines. How does it work, when should we use it, what can we expect and 

where does it fit in with other systems? 

The New Biomarker Qualification Process – What to expect and how does it 

work? How does it fit together with Scientific Advice? 

Bruno Flamion, Chair Scientific Advice Working Party (SAWP), CHMP; Professor 

Clinical Pharmacology, University of Namur, Belgium 

Biomarker Qualification - When to use it and why. An Industry View 

Duncan McHale, Vice President, Translational Sciences, DECS, AstraZeneca, UK 

Strategic Pathways for Biomarker Qualification 

Lawrence J. Lesko, Director, Office of Clinical Pharmacology and 

Biopharmaceutics, OTS, CDER, FDA, USA 


EFFICACY: EVIDENCE AND STUDY DESIGNS IN PERSONALISED MEDICINES 




Developing a targeted therapy requires different elements and approaches from 

the traditional development programmes. What needs to be addressed in the 

clinical trials and development frameworks for a successful outcome? What can 

we learn from experience to date and what are the appropriate directions for 

the future? 

Individualisation of Medical Treatment: Design and Strength of Evidence 

Issues in Pharmacogenomics Clinical Trials 

Sue-Jane Wang, Associate Director, Adaptive Design & 

Pharmacogenomics/Pharmacogenetics, OB, OTS, CDER, FDA, USA 

Exploratory Pharmacogenetic Analysis of Efalizumab Responders 

Emmanuel Monnet, Head of Biomarkers - Neurology and Autoimmune Diseases, 

Merck Serono International S.A., Switzerland 

Back to the Basics: Capitalising on Novel Approaches for Establishing 

Prospective Diagnostics in Clinical Oncology Development 

Jennifer Weidman, Senior Director, Research and Development, Cancer 

Advances, Inc., USA 




SAFETY: EVIDENCE AND STUDY DESIGNS IN PERSONALISED MEDICINES 


Peter Arlett, Head of Pharmacovigilance and Risk Management, European 


A personalised medicine approach can be developed “upfront”, or it can be 

developed post-authorisation. This session will explore methodologies and case 

studies in the field of post-authorisation targeting of therapies. What are the 

hurdles and how can the increasing understanding of and information about the 

product be passed effectively to the people who need it? 

Principles of Clinical Study Design for Biomarkers and Co-Diagnostics 

Jeffrey Bojar, Vice President of Legal and Regulatory Affairs, Biodesix, Inc., USA 

Drug Plasma Levels and Adverse Drug Reactions: Usefulness of the TDMplus 

algorithm 

Jan Willem van der Velden, Director, Mesama Consulting, Switzerland 


DIAGNOSTICS – IF THIS IS SUCH A CRUCIAL ELEMENT OF THE WHOLE FIELD, 

WHAT ARE WE DOING TO SUPPORT, ENCOURAGE AND PROTECT THE 

DIAGNOSTICS FIELD? 


Georgette Lalis, Director ENTR/F, European Commission, EU 

This session will explore the balance between public health and the need to 

have a diagnostics industry with a meaningful business model. 

Diagnostics - Regulatory and legal incentives for development and what can 

be improved 

Peter Bogaert, Managing Partner, Covington and Burling LLP, Belgium 

The Value of Diagnostics 

James Creeden, Head of Medical Affairs, Roche Diagnostics Ltd., Switzerland 

A Practical View of Medicine-Diagnostics Co-Development – An SME 

perspective 

Tim Kievits, CEO, Pamgene, The Netherlands 

Panel with Mary Baker, MBE, President of European Federation of Neurological 



INTERNATIONAL REGULATORY FRAMEWORKS – CONVERGING OR 

DIVERGING? A PANEL DISCUSSION 


Emer Cooke, International Liaison Officer, European Medicines Agency, EU 

Regulatory representatives from three main regions will give an overview of the 

status in their regions, highlight issues and provide suggested potential 

solutions before moving to an open panel discussion with a leading industry 

representative. 

Marisa Papaluca-Amati, Head of Scientific Support and Projects, European 


Lawrence J. Lesko, Director, Office of Clinical Pharmacology and 

Biopharmaceutics, OTS, CDER 


Theme 8 

Taking the European Regulatory Infrastructure Forward 



Union, UK 

Thomas Kühler, Thomas Kühler, Regulatory Affairs Specialist, Sweden 

This theme will address many issues concerning the procedure of gaining 

regulatory approval and market access for medicinal products in Europe. The 

European Commission has set out both a communication and several legislative 

proposals on patient information, counterfeit medicines and pharmacovigilance. 

This is draft legislation that will go via the co-decision procedure through the 

Council and the European Parliament. 

The European Medicines Agency is changing to be able to handle the additional 

responsibilities of Advanced Therapies and the changing nature of the types of 

marketing applications that are being filed in the Centralised Procedure. As the 

CHMP plays a pivotal role at the European Medicines Agency, its role and 

objectives will be described and a survey of all applications in 2008 will provide 

key learning points for development of medicinal products. The European 

Medicines Agency sets out its strategic vision in the publication of Road Maps. 

The success of the Road Map to 2010 and the map for the next five years will 

give an understanding of the direction the Agency will follow. As a complement


to the Agency’s Road Maps, the Heads of Agencies released their Strategy 

Paper setting out the ambition for National Competent Authorities in the future. 

Stakeholders are interested in the resources that are available to support the 

Decentralised and Mutual Recognition Procedure and how they will be 

allocated. Industry sees much to gain in a dialogue with regulators. Ways that 

dialogue may be enhanced to the benefit of both industry and Agencies will be 

explored so that creative suggestions can be offered for further discussion. 

Recognising that the approval of a marketing application is the first step to the 

availability to patients of a medicine, the vital role and contribution of Health 

Technology Assessment bodies will be presented so that the interaction 

between the two organisations can be understood by stakeholders. 

Europe is one of the three major pharmaceutical markets in the world and 

cooperation between regulatory agencies in these countries and others are 

important for public health. 


16:30 Session 0801 

PHARMACEUTICAL PACKAGE - THE LATEST INFORMATION 


Truus Janse-de Hoog, Staff member MEB, European Cluster, Chair CMD(h), 


The European Commission adopted three legislative proposals in December 

2008: “The Pharmaceutical Package”. 

The aim of the package: 

• to tackle the growing issue of counterfeiting and illegal distribution of 

medicines 

• to better protect patients by strengthening the EU system for safety 

monitoring of medicines 

• to enable citizens to get high quality information on prescription-only 

medicines. 

The legal proposals are being discussed at the Council Working Party on 

Pharmaceuticals and Medical Devices and also in the European Parliament (EP). 

A representative from the European Commission and the Council Working Party 

will give an update on the current status. What are the main points for 

discussion and what is the expected timeframe for discussion? A representative 

from industry will present their view on the legislative proposals. 

European Commission Perspective 

Martin Terberger, Head of Pharmaceuticals Unit, DG Enterprise and Industry, 

European Commission, EU 

The Pharmaceutical Package: An update from discussions in the Council 

Working Party 

Johan Lindberg, Deputy Director, Ministry of Health and Social Affairs, Sweden 

The Pharmaceutical Package: A view from the industry 

Meni Styliadou, Head, European Public Affairs, Novartis, Belgium 



INTERNATIONAL COOPERATION AMONG REGULATORY AGENCIES 


Marie A. Dray, President, International Regulatory Affairs Group LLC, USA 

For the last few years, reports on privileged discussions among regulators on 

topics such as Regulatory Simplification under the auspices of the Transatlantic 

Dialogue, have been provided publicly at DIA Annual and EuroMeetings. 

This session will update the audience, to the extent not limited by 

confidentiality, on the current status of bilateral discussions between the EU/ 

European Medicines Agency and the US FDA on Regulatory Simplification and 

Theme 8 

other current topics. In addition, a spokesperson for the ICH (International 

Conference on Harmonisation) will be invited to report on the status of 

communications under the ICH umbrella and the future of ICH. Finally, each 

speaker will be invited to answer candid questions from the audience on topics 

presented, as well as on related regulatory topics which might have been 

reported, elsewhere. 

European Medicines Agency Perspectives on Regulatory Cooperation and 

Communications 

Thomas Lönngren, Executive Director, European Medicines Agency, EU 

FDA’s Views on Continued Cooperation among Regulatory Authorities, under 

the New US Administration 

Murray Lumpkin, Deputy Commissioner, International and Special Programs, 

OC, FDA, USA 

The Value and Benefit of the ICH to Regulators—The CTD, the Common 

Regulatory Language 

Justina A. Molzon, Associate Director for International Programs, CDER, FDA, 

USA 


HEADS OF MEDICINES AGENCIES 


Craig McCarthy, Managing Director, CAMPHARM, France 

This session will focus on the HMA strategy paper and some topical regulatory 

challenges and initiatives that the HMA are pursuing as part of their strategy. 

The speakers in this session, who are key leaders of their respective national 

regulatory agencies, will outline some of the challenges from this decade and 

initiatives for the next decade in the development of this strategy. 

HMA Strategy Paper 

Kent Woods, Chief Executive, MHRA, UK 

HMA Initiatives on Clinical Trials 

Jean Marimbert, Director General, Afssaps, France 

HMA Initiatives on Resourcing 

Jytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark 


CHANGES IN REGULATORY AGENCIES TO MEET FUTURE CHALLENGES 


Thomas Kühler, Regulatory Affairs Specialist, Sweden 

The regulatory landscape is under constant change as agency workload is ever 

increasing and new scientific committees are created. Additional pieces of 

legislation are put in place, the different marketing authorisation procedures are 

extensively used and new work-bits, funded or not, are emerging. This session 

will focus on the relationship between the different scientific committees, how 

the work content is transformed and measures taken by regulatory agencies to 

cope with these changes. The session will also explore what Industry’s 

expectations on the agencies in those resource-demanding times are. 

Architecture of European Medicines Agency Scientific Committees and their 

relationship with National Agencies – the Commission Perspective 

Martin Terberger, Head of Pharmaceuticals Unit, European Commission, EU 

Swissmedic’s Reorganisation: Mission Accomplished? 

Cordula Landgraf, Head of Networking, Swissmedic, Switzerland 

What Industry Wants from Regulatory Authorities 

Julian Thompson, Vice President, Worldwide Regulatory Strategy, Pfizer Ltd., 

UK 

31

32 



CHMP OVERVIEW 



Union, UK 

The Committee for Human Medicinal Products plays a vital role in the 

Centralised Procedure and in handling referrals from the Mutual Recognition 

and Decentralised Procedure. This session will describe the CHMP work 

programme for 2010 as well as the projects that were successfully concluded 

from last year. The analysis of all Marketing Authorisation applications that were 

completed in 2009 will be discussed and key learnings highlighted. The 

Scientific Advisory Groups contribute in a significant way to the work of CHMP 

and their input to the overall success of the Centralised Procedure will be 

shared. 

CHMP – Its Achievements and Future Direction 

Eric Abadie, Chairman, CHMP, European Medicines Agency; General Directorate, 


Developments in Interaction between CHMP and its Working Parties 

Xavier Luria, Head of Sector Safety and Efficacy of Medicines, European 


The Valuable Contribution of Scientific Advisory Groups 

Francisco Pignatti, Scientific Administrator, Safety and Efficacy of Medicines, 





DIALOGUE AND SCIENTIFIC ADVICE: ACHIEVING GOALS AND MAKING IT 

HAPPEN 


Chris Griffett, Vice President, Regulatory Affairs, Celgene, USA 

Effective dialogue between the regulators and the regulated in Europe has been 

shown to be a fundamental plank in designing programs for both the 

development of new medicines and enabling marketing approvals. This 

engagement with the Health Authorities enables them to reflect on specific 

requirements and on the other hand, provides the opportunity for companies to 

make the case for justifying any chosen path for development. Scientific Advice 

at the EU and/or national levels is fully encouraged. Dialogue has also driven 

strong debate in policy matters, impact assessment of new guidelines, 

proposed new rules, etc. In Europe we have an excellent track record. 

Many challenges remain. Health authorities strive for greater transparency. 

Globalisation looks to align development programmes which focus on efficiency 

and simultaneous submissions for clinical trials or marketing approvals in all 

regions. How then can we optimally ensure alignment around the globe? 

We have a great opportunity. The dialogue between health authority 

stakeholders around the world and Health Authorities aims at exposing 

divergence and driving alignment. How can this best be achieved? What 

opportunities can be exploited? At this session, we have invited speakers who 

have proven track records as opinion leaders in regulatory affairs. These will 

represent health Authority thinking as well as cutting edge industry know-how. 

We will explore options and evaluate ideas aimed at better strategic planning 

for dialogue and scientific advice in Europe, and in global context. 

View of the Health Authority at National and EU/CHMP Levels 

Gonzalo Calvo Rojas, Member of CHMP, Agency on Medicines Healthcare 

Products, Spain 

Presentation title to be confirmed 

Peter Lassoff, Vice President, Europe, PAREXEL Consulting, UK 

Panel with Spiros Vamvakas, Head of Scientific Advice, Technical Coordinator 

for ICH, European Medicines Agency, EU 

11:00 Session 0407/0807 

INFLUENCE OF HTA ON REGULATORY DECISION MAKING: REALITY? AN 

OPPORTUNITY? A THREAT? (JOINT SESSION WITH THEME 4) 





Getting to the Right Evidence for Licensing and HTA Authorities at the Point 

of Launch: An achievable endpoint? 

Franz Pichler, Portfolio Manager, CMR International Institute for Regulatory 

Science, UK 


SIMULTANEOUS GLOBAL DEVELOPMENT: PRESENT HURDLES, FUTURE 

CONSIDERATIONS AND OPPORTUNITIES 


Ian Laws, Vice President, Global Regulatory Affairs, Cardiovascular and 

Metabolic Diseases, GlaxoSmithKline, USA 

Given the current size and complexity of pharmaceutical development 

programmes, continued improvements to streamline the development of new 

and innovative medicines are critical. Despite significant operational challenges, 

the conduct of global studies which follow the same protocol across multiple 

regions, is considered by the innovative pharmaceutical industry as a very 

efficient approach to clinical development. This philosophy is in line with the 

drivers behind the creation of the International Conference for Harmonisation 

(ICH) guideline documents, including ICH E-5 (Ethnic Factors in the 

Acceptability of Foreign Clinical Data). However, despite very significant 

progress made with the implementation and acceptance of ICH guidelines, 

barriers to the conduct and acceptability of global development approaches 

still remain. This issue has been recognised as significant, not only by the 

pharmaceutical industry, but also by a number of governmental agencies, and 

efforts now exist to evaluate the challenges associated with the conduct of 

global studies. 

This session will review the current barriers, and with an emphasis on Asia, will 

look at practical steps being taken to facilitate both global development and 

acceptibility of these data in regional marketing applications. It will also review 

potential future issues and considerations. 

Henrietta Ukwu, Vice President, Global Regulatory Affairs, Wyeth 

Pharmaceuticals, USA 

Ulrich Taglieber, Chair, Simultaneous Global Development Committee, PhRMA, 

USA 

Ekopimo Ibia, Director, Global Medical and Regulatory Policy, Merck Research 

Laboratories, USA 

Theme 9 

Risk Management 


Trevor Gibbs, Executive Vice President, ii4sm, Switzerland 

Brigitte Keller-Stanislawski, Head, Pharmacovigilance, Paul-Ehrlich-Institut, 

Germany 

Risk Management remains a topic on everyone’s agenda. This year, we will 

reflect on the implementation of regulations by the European Medicines Agency 

and FDA over the last few years, describe some of the major research initiatives 

in the area and provide practical working examples from industry and 

regulators. 

Above all, the theme will reflect the multi-disciplinary approach that is required


to create a clear picture of what we know, what we don’t know and how to 

address harm minimisation and benefit maximisation for patients and 

customers. 


16:30 Session 0601/0901 

RISK MANAGEMENT FOR SWITCH PRODUCTS 

(JOINT SESSION WITH THEME 6) 




This session will cover the challenges of taking prescription products to overthe-counter 

use at the European level and how these can be addressed with 

creative pharmacovigilance and risk management approaches. There is an 

increasing desire for making medicines available without a prescription and for 

patients to take greater responsibility for their health. The criteria that define a 

successful OTC switch will be discussed using data collected across key 

pharma/consumer companies, from a case study and from the perspectives of 

the European Regulatory authorities. 

Current and Optimal Approaches, Including Industry Perspectives for 

Innovative Switches 

Chris Holmes, Director, World Class International, UK 

A Case Study of Risk Management Planning for a Novel Switch: Orlistat 



Regulatory Expectations of Risk Management Programmes for Innovative 

Switches 



09:00 Session 0902 

REGULATORY DEVELOPMENTS IN RISK MANAGEMENT IN THE EU AND US 


Brigitte Keller-Stanislawski, Head, Pharmacovigilance, Paul-Ehrlich-Institut, 

Germany 

The objective of this session will be to provide an update of the implementation 

of risk management regulations by the European Medicines Agency and FDA 

over the last few years. In the EU there will be feedback from a project 

completed on the quality and completeness of risk management plans 

submitted by companies during the first two years of the new EU risk 

management legislation. Deficiencies in RMPs will be outlined and proposals for 

improvement as well as changes to current guidelines will be described. More 

generally there will be a draft outline of new legislation being proposed in the 

EU for the future in the context of risk management planning. An FDA 

representative will describe the latest developments at FDA and 

implementation of the FDAAA and REMS. A pharmaceutical industry 

representative will provide their company’s experience in meeting the differing 

risk management regulations in the EU and US. The session will be completed 

with a roundtable panel discussion on global risk management. 

Regulatory Update from the EU 

Peter Arlett, Head of Pharmacovigilance and Risk Management, European 


Regulatory Update from the US 


Industry Update 

Jacques Mascaro, Senior Vice President, Global Regulatory Affairs, 

Pharmacovigilance and Quality, Elan Pharma International Ltd., Ireland 


Panel discussion: Global Approach to Risk Management with speakers and 

Panos Tsintis, Medical Director, Choice Pharma, UK 

11:00 Session 0903 

NON-CLINICAL SUPPORT TO AID RISK MANAGEMENT IN EARLY PHASE 

STUDIES 


Phil Wilcox, Vice President, Non-Clinical Safety Projects, Safety Assessment, 


This session looks at 3 different situations where non-clinical data are very 

important in managing safety risks in early clinical studies. The topics to be 

discussed include the selection of starting and stopping doses for Phase I 

studies (including exploratory clinical trials), managing compounds with an 

identified cardiovascular hazard, and how to progress compounds that have 

been shown to induce convulsions in non-clinical species. 

Use of Non-Clinical Data in Selecting Starting and Maximum Clinical Dose for 

Phase I Studies, and Dose Escalation Strategy 

David Jones, Expert Pharmacotoxicologist, MHRA, UK 

Integrated Non-clinical Cardiac Safety Assessment and Translational 

Biomarkers to Support the Design of Clinical Studies on Cardioactive 

Compounds 

Mark Holbrook, Executive Director, Global Safety Pharmacology, Pfizer, UK 

How to Manage Convulsion Risk Identified in Non-Clinical Species: Approach 

to early clinical studies 

Andrea Terron, Director of Neuroscience Projects, Safety Assessment, 

GlaxoSmithKline, Italy 


WHEN DO ADVERSE EFFECTS QUALIFY AS UNDESIRED EFFECTS? 


Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany 

This session will review the challenges of evaluating a causal association of 

adverse drug effects in different scenarios during a product lifecycle and 

provide recommendations for decision making. 

Decision Making in Drug Safety: Science or prejudice, public health or politics, 

medical or medico-legal? 

Glyn Belcher, Vice President, Drug Safety and Risk Management International, 

Biogen Idec Ltd., UK 

The Tamiflu Example – What complete analysis can mean 

Barbara Donner, Safety Science Leader, F. Hoffmann-La Roche AG, Switzerland 

Decisions – Are they evidence based? 




RESEARCH AND INTERNATIONAL INITIATIVES IN RISK MANAGEMENT 



The session will describe international research initiatives in the area of risk 

management. These will include the latest developments in methodologies for 

signal detection and data mining and feasibility of using electronic health 

records and large automated healthcare databases. Speakers will cover major 

initiatives undertaken by regulators (European Commission, European 

Medicines Agency, FDA), academia, CIOMS and public-private partnerships. 

Latest Developments in Signal Detection and Data Mining 



33

34 

Theme 10 


Public - Private Partnerships in Europe and ENCePP Initative 

Henry Fitt, Head of Coordination and Networking, European Medicines Agency, 

EU 

International Initiatives: CIOMS update on signal detection, eHR feasibility 

study 



09:00 Session 0906 

PERFORMANCE, QUALITY CONTROL AND AUDIT IN PHARMACOVIGLANCE 

AND RISK MANAGEMENT 


Trevor Gibbs, Executive Vice President, ii4sm, Switzerland 

There is a complete range of flavours of signal management depending on 

whether you are: 

• in a small or large organisation 

• in a vaccine, consumer or pharma environment 

• a data mining practitioner or not 

What can we learn from this range of flavours and what are the regulatory 

expectations independent of the attributes of the organisation? 

Regulators Expectation with Respect to Signal Management Activities and the 

Corresponding QC and Audit Aspects 

Magda Daudin, Head of Pharmacovigilance Inspection Unit, Afssaps, France 

Overall Performance of a Signal Management System - What Does the Data 

Tell Us 

Nassrin Payvandi, TA Head - Safety Evaluation & Risk Management, 


Using AE data to Identify Product Quality Issues 

John Ayres, Senior Director, Product Safety Assessment, Eli Lilly & Company, UK 


RISK MINIMISATION – HOW TO MEASURE? HOW TO EVALUATE? 


Elizabeth B. Andrews, Vice President Pharmacoepidemiology & Risk 

Management, RTI Health Solutions, USA 

The focus of this session will be on implementation of risk minimisation plans 

and their outcomes. The session will introduce some recent examples of 

measurement of effectiveness of implemented risk minimisation measures. 

Risk management guidance is available across several regulatory regions since 

2005. The evaluation of the effectiveness of risk minimisation actions is a critical 

component of risk management, but also one of the more complex areas to 

develop and implement. The goal of this session is to share experiences from 

the perspectives of a pharmaceutical company, regulatory agency and a 

research organisation. 

Integrated Benefit/Risk Management throughout the Lifecycle: Learnings 

from REMS/RMPs and recommendations 

Philippe Van der Auwera, Global Head of Safety Risk Management & EEA-QPPV, 


How to Evaluate Risk Minimisation - A perspective from the European 

Medicines Agency 

Stella Blackburn, Scientific Administrator, Pharmacovigilance and Risk 


Where the Rubber Meets the Road - What are we learning from the RMP/REMS 

experience? Perspective from a research organisation 

Elizabeth B. Andrews, Vice President Pharmacoepidemiology & Risk 

Management, RTI Health Solutions, USA 


PANDEMIC FLU 


John Purves, Head of Quality of Medicines, European Medicines Agency, EU 

H1N1 Pandemic flu has provided opportunities to prepare for and apply 

learnings from previous health related crises. It is timely to learn more about 

those preparations, both from the perspectives of European Regulators and the 

Pharmaceutical industry. What is the decision making framework for licencing 

medicines before they are available, how does that decision making framework 

accommodate the perception of a changing context. 

Crisis Management Planning—The Regulatory perspective 

John Purves, Head of Quality of Medicines, European Medicines Agency, EU 

Benefit Risk Evaluations- A migrating framework 


Theme 10 

The Informed Patient 


Nick Sykes, Director, Regulatory Policy & Intelligence, Pfizer Ltd., UK 



Involved and Informed Patients – Why? 

An overview and discussion on the use and provision of information on 

medicinal products to and by patients covering the following areas: 

1. The use of information by patients: Will having more information enable 

patients to provide an increasingly meaningful contribution to the 

management of their healthcare? What contribution to healthcare systems 

can knowledgeable patients make? 

2. An exploration of the information on medicines that is available to patients 

and information that is wanted by patients focussing on: 

• The impact to patients with the availability (or lack thereof) of information 

on medicinal products 

• An analysis of what information patients would like and in what form vs. the 

information 'holders'/producers are willing to give against the backdrop of 

what information can legally be provided to patients 

• Can patients fully understand the information currently available to meet 

their healthcare needs? 

3. A discussion on whether all access points for information are utilised to the 

best effect: 

• The internet is not the nirvana – ‘traditional’ methods for providing 

information are still important 

• The pros and cons of centralised access points and greatly dispersed access 

points 

• How can all stakeholders ensure consistent communication across states, 

languages and cultures to facilitate a common understanding?



16:30 Session 0401/1001 

PATIENT INFLUENCE ON REGULATORY DECISIONS: HOW MUCH DO THEY 

AND SHOULD THEY HAVE? (JOINT SESSION WITH THEME 4) 


Frits Lekkerkerker, Member NDA Advisory Board, NDA Regulatory Science Ltd., 

UK 

Patient organisations are increasingly involved in the activities of the European 

Medicines Agency, but how much influence do they (and should they) have? 

This session will consider the views of various stakeholders on the involvement 

of patients in the work of the European Medicines Agency and its scientific 

committees, as they make regulatory decisions in product assessment and on 

guideline development, etc. The inclusion of patients’ perspectives in decisions 

on benefit/risk assessments will be discussed, as will the balance that needs to 

be met between those decisions and patients’ subsequent treatment choices. 

How Much Influence Do and Should Patients Have on Regulatory Decisions? 

Alistair Kent, Director, Genetic Interest Group, UK 

Are Patients’ Perspectives Heard and How Can They Be Captured in 

Benefit/Risk Decisions? 

Jeremiah Mwangi, Senior Policy Officer, International Alliance of Patients’ 

Organisations (IAPO),UK 

How Can the Right Balance be Struck between Regulators’ Decisions and 

Patients’ Choices? 

Patrick Salmon, CHMP, European Medicines Agency, Senior Medical Assessor, 

Irish Medicines Board, Ireland 

Panel with Isabelle Moulon, Head of Medical Information, European Medicines 

Agency, EU 


09:00 Session 1002 

PHARMACEUTICAL PACKAGE: INFORMATION TO PATIENTS PROPOSALS – 

WHAT DIFFERENCE WILL THEY MAKE? 


Paul Woods, Global Compliance Policy Director, AstraZeneca, UK; Co-Chair 

EFPIA Information to Patients Task Force 

This session will take the form of a discussion panel on the Commission 

proposal that will permit industry to provide information directly to patients. 

The panel will represent stakeholders holding a variety of different points of 

view including industry, patients and the Commission. 

Update on the Information to Patients legislation proposal 

Martin Terberger, Head of Pharmaceuticals Unit, European Commission, EU 

A Patient’s View of the Legislation Proposal – Does it fulfil patients’ needs? 

Nicola Bedlington, Executive Director, European Patients Forum 

Industry Thoughts on the Information to Patients Proposal 

Paul Woods, Global Compliance Policy Director, AstraZeneca, UK; Co-Chair 

EFPIA Information to Patients Task Force 


11:00 Session 1003 

COMMUNICATION OF INFORMATION ON MEDICINAL PRODUCTS (1) – HOW 

CAN A BALANCE BE ACHIEVED BETWEEN LEGAL RESTRICTIONS AND 

PATIENT EXPECTATIONS? 



This session will look at the legal restrictions that are placed on the provision of 

information to patients (in particular, looking at differences between Member 

States), at inconsistencies between different types of products (Rx and non-RX) 

and how the rules differ depending on who provides the information. It will then 

look at what are the expectations of patients in terms of information and how 

much is restricted from a legal basis (and how much is already available or 

could be made available from different stakeholders). Finally reviewing whether 

the current proposals from the Commission get close to meeting the needs of 

patients (or providing anything of use). 

Outlining the Legal Restrictions that are Placed on the Provision of Information 

to Patients - In particular the differences between the Member States, 

inconsistencies between different types of products (Rx and non-RX), and the 

specific restrictions for particular providers. 

Defining the Information Expectations or Needs of Patients 

Jan Geissler, Executive Director and co-founder, European Cancer Patient 

Coalition (ECPC), Germany 

Outlining the Legal Restrictions that are Placed on the Provision of 

Information to Patients - In particular the differences between the Member 

States, inconsistencies between different types of products (Rx and non-RX), 

and the specific restrictions for particular providers 

Maximilian von Olenhusen, Policy Counsel, Novartis European Public Affairs, 

Belgium 

What Are the Legal Changes Necessary to Meet Patients’ Expectations or 

Needs and Are the Current Proposals from the Commission Suited to Bring 

those Changes? 



COMMUNICATION OF INFORMATION ON MEDICINAL PRODUCTS (2) – 

FACTORS TO CONSIDER TO ENSURE OPTIMUM ACCESSIBILITY AND 

UNDERSTANDING 


Nick Sykes, Director, Regulatory Policy & Intelligence, Pfizer Ltd., UK 

Europe is a union of many different cultures, languages, and social spectra. The 

differences between Member States can affect how patients can access and 

understand information that is available on medicinal products. This session will 

aim to explore some of the differences and look at what can be achieved to help 

ensure that as many patients as possible in Europe receive and understand 

information on their medicines. 

Opportunities for Greater use of Available Information to Maximize Patient 

Benefit 

Ruth Stone, Director, Comply-Services, UK 

Patients’ Understanding of the Benefit/Risk Decision Making and 

Determination 


Tools Currently Available to Make Information Available to Patients 

Martine Zimmerman-Laugel, Director, Pharmaceutical Affairs Europe, Alexion 

Europe 

35

36 

Theme 11 



ARE INFORMED PATIENTS COST-EFFECTIVE? HOW TO ENSURE THAT 

PATIENTS UNDERSTAND THE DECISIONS BEING MADE ON THEIR MEDICINES 


Jean Mossman, Consultant and Policy Advisor to European Federation of 

Neurological Associations (EFNA), UK 

The aim of the session is to look at how patients can understand decisions made 

on their medicines after the product has reached the market. One area to be 

considered is how patients can understand and contribute to the decisions 

being taken by the Heath Technology Assessment bodies on whether a 

medicine will be made available through a country's healthcare system. An 

additional area to look at is where patients can add to the knowledge gathered 

on the safety of a medicinal product and the analysis of that knowledge as the 

product is used in a population wider than that used for clinical evaluation. 

Can Regulatory Authorities Take Account of the patients’ Needs in their 

Decisions? How do Regulatory Authorities consider the Patient’s Need for 

Efficacy rather than the Consumer’s Need for Safety? 


Understanding How Decisions Are Made about Reimbursement: The role of 

patients in health technology assessment 

Guiseppe La Torre, Associate Professor Clinical Medicine and Public Health Unit, 

Sapienza University of Rome, Italy 

Supporting Individual Patients in Decisions about their Medicines: How can 

patients be more involved in decisions about which drugs are available? 

Anita Waldmann, President, Myeloma EuroNet, Germany 


09:00 Session 1006 

HOW INVOLVED CAN INFORMED PATIENTS BE IN THE DEVELOPMENT AND 

COMMERCIALISATION OF MEDICINES? 


Cecilia Potez, Director, EU and International Regulatory Policy & Intelligence, 


Citizens and society in the modern world take a more active interest in 

healthcare issues than was traditionally the case. They increasingly wish to be 

more involved in development decisions but how much input to the decisionmaking 

will industry relinquish, particular when making determinations on 

clinical endpoints and PROs. Is drug development really meeting the needs of 

patients and society? 

European Medicines Agency View 


Sylvia Lion, Director, Global Advocacy & Professional Relations, Endocrinology, 

Lilly, France 

Patient View 




PATIENT USE OF INFORMATION ON MEDICINAL PRODUCTS 


Anders Olauson, President, European Patients’ Forum, Sweden 

The overall aim of the session is to look at how patients use currently available 

information. In particular, looking at how patients use information that they get 

from healthcare professionals, fellow sufferers, providers of the treatment and 

other sources. This session will have a greater focus on diseases that affect the 

wider society (e.g. oncology, stroke, diabetes etc). 

Session under development 


WHAT INFORMATION DO PATIENTS WANT ON MEDICINAL PRODUCTS AND 

HOW FAR DO THE CURRENT PROVISIONS GO TO MEET THESE NEEDS? 




Different patients have different information needs depending on many factors 

including the condition itself, the stage of the condition and the patient 

themselves. This session will look to ask the question whether the information 

that a patient needs and wants is already available - they just need to know 

where to find it. 

Provision of Patient Information by the Pharmaceutical Industry – The Hamlet 

approach “To Trust or not to Trust” 

Alastair Benbow, Senior Vice President and Head of Global Clinical Safety and 

Pharmacovigilance, GlaxoSmithKline, UK 

Patient View 

Nikos Dedes, Chair, Policy WG, European AIDS Treatment Group, Greece 

Patient Information, The Case for Anarchy 

Richard Smith, Chairman of the Board of Directors, Patient Knows Best, UK 

Theme 11 

eHealth 


Valdo Arnera, General Manager, Europe, PHT Corporation, Switzerland 


Standards, sanofi-aventis, France 

The influence of technology on healthcare and clinical development has seen an 

unprecedented growth in recent years. This theme intends to cover the value 

brought by these new technologies, whether these have been used for a while, 

like EDC or ePRO, or whether they are emerging or still a vision of what they 

could bring to the way we will develop drugs and treat patients in the next 10 

years. 


16:30 Session 1101 

THE NEW IT ARCHITECTURE FOR MEETING THE CHALLENGES OF eHEALTH 




The acceleration of the adoption of Electronic Health Records (EHR) all over the 

globe has pushed the pharma R&D to start to look at ways of allowing patient 

eData to be used in clinical trials. Countries like the Scandinavian countries, the 

UK or Netherlands have been paving the way to adopt EHR in their respective 

countries, needing the implementation of national Heath IT infrastructures that 

will be presented. Also, in the US, the FDA has requested more and more data 

to be submitted in an electronic format, and the new FDA IT architecture wil 

also be presented. 

How to Use Pharma Architecture to Optimise R&D 

John Aggerholm, Project Director, HERAX A/S, Denmark 

The eSource Regulatory Point of View 

Fergus Sweeney, Head of Compliance and Inspections, European Medicines 

Agency, EU


The New NCI IT Architecture 

Charles Mead, Senior Director, Healthcare and Life Sciences Strategy, Booz Allen 

Hamilton, Chief Technology Officer, NCI, USA 



PATIENT AND CLINICIAN REPORTED OUTCOMES USE IN GLOBAL MEDICAL 

PRODUCT DEVELOPMENT: AN UPDATE ON INDUSTRY BEST PRACTICE AND 

REGULATORY ISSUES 


John Weiler, President, Compleware Corporation, USA 

Clinician rated or reported outcomes (ClinROs) have historically been the basis 

for labelling claims, but both the European Medicines Agency and the FDA have 

acknowledged the importance of patient reported outcomes (PROs) and, 

increasing, new medical products are being approved based on PROs as well. 

Regardless of the type of study endpoint used, outcomes need to be valid and 

reliable and collected with integrity. It is critical that clinical trial sponsors 

ensure the content validity of ClinROs and PROs. In addition, if the study 

endpoint is collected electronically, steps must be taken to ensure measurement 

equivalence. This session will detail the important content validity issues; 

discuss study endpoint validation study designs and case studies; and share the 

associated regulatory perspective. The audience will gain an understanding of 

today’s regulatory considerations and industry best practice for PROs and 

ClinROs. 

Regulatory Perspectives when PROs and ClinROs are Deployed 

Laurie Burke, Associate Director, Study Endpoints and Labeling Development, 

Office of New Drugs, CDER, FDA, USA 

Content Validity: Issues in the Development of Instruments 

Jane Scott, Research Director, MAPI Values, UK 

Leveraging Technology and Ensuring Measurement Equivalence for PROs and 

ClinROs 

Keith Wenzel, Senior Director, Product Management, Perceptive Informatics, 

USA 


EDC CASE STORIES 


Julianne Hull, Senior Director, Global Development Data Operations, Pfizer, UK 

If 2007 has been the year when, for the first time in clinical trials history, the use 

of eCRF has taken over the use of paper, there is still a lot of room for 

improvement in the use of Electronic Data Capture and associated etools. 

Development of new drugs implies more than ever before, the participation of 

multiple countries and sites around the globe which raises new challenges. This 

session will include case studies and various experiences presented from 

pharma as well as the Contract Research Organisation (CRO) industry. 

EDC - The Tool to Enable Speedy Decision Making 

Mireille Zerola, Data Management Specialist III, Boehringer Ingelheim, Ltd., UK 

Pros and Cons of Different EDC Tools in Different Scenarios with Focus on 

Enabling Speedy Decisions 

Thomas O’Leary, Vice President, Clinical Data Management, ICON plc, Ireland 

Accelerate Decision Making Through Real Time Dictionary Coding 

Douglas Burgener, Product Manager Data Management Solutions, Perceptive 

Informatics, USA 



EMERGING TECHNOLOGIES FOR OPTIMISATION OF PATIENT TREATMENT 


Valdo Arnera, General Manager, Europe, PHT Corporation, Switzerland 

If the use of "e" is increasing in the clinical trials arena, we can also start to see 

the benefits of using technology in "standard" patient care, including but not 

only in the EHR domain, allowing better follow-up and better treatments, as 

well as often reducing the cost of therapies. This is the real future of eHealth 

where telemedicine for example could translate into better and cheaper medical 

care for every patient. This session will present some case studies in western 

countries but also describe the efforts put in place to give access to EHR in 

emerging nations. 

An eHealth Project Providing Integrated Care and Risk Management for 

Coronary Disease with Direct Patient Communication through an EDC system 

Claus Lindenau, Head, Business Development, XClinical GmbH, Germany 

How to Prevent COPD Exacerbation Using an eDiary 

Gerard Criner, Pulmonologist, Professor, Temple University Medical School, USA 

Joint Effort for Providing eHealth Technologies to Emerging Nations 

Charles Jaffe, CEO, HL7, USA 


IMPROVING DRUG SAFETY THROUGH THE USE OF NEW TECHNOLOGIES 


Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk 


Drug safety monitoring can be considerably improved through the use of new 

technologies. This session provides insights into these new possibilities from 

different point of views 

Evaluating Drug Safety and Effectiveness through the Lens of eHealth Data 

Wayne Kubick, Vice President, Phase Forward Lincoln Safety Group, USA 

Integrated Web-Based Tools Supporting Regulatory Bodies: From clinical trial 

national registries to the postmarketing safety surveillance tools 

Marisa De Rosa, Head of Systems and Services for Health Department (SISS), 

CINECA Inter-University Consortium, Italy 

FDA View 

Stephen Wilson, Director, Division of Biometrics III, CDER, FDA, USA 



HEALTHCARE INTEROPERABILITY STANDARDS 


Wolfgang Summa, Executive Vice President, Business Development, 

OmniComm Systems, Germany 

With the involvement of Standards Development Organisations such as ISO, 

CEN, HL7, CDISC and IHTSDO, the development of international standards for 

the monitoring of drug safety has taken a new dimension. After a short 

introduction on how these standards are currently being developed and how 

they relate to each other, this session will provide an overview of the newly 

developed standards, followed by a panel discussion with European Medicines 

Agency and industry speakers. 

What’s New about Standards? A General Overview 



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Progress on the Creation of ICH Standards for Safety Reporting and 

Identification of Medicinal Products 

Andrew P. Marr, Director, Global eRegulatory Development, Global Regulatory 

Operations, GlaxoSmithKline, UK 

Emerging ICH Technical Standards for Safety & Identification of Medicinal 

Products 

Raun S. Kupiec, Senior Director, Regulatory Affairs, Genzyme Europe, The 

Netherlands 

Panel with Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk 



UTILISATION OF ELECTRONIC MEDICAL RECORDS IN CLINICAL 

DEVELOPMENT 




With the adoption of electronic Health Records throughout the world, their use 

for Clinical Research is increasingly attractive. Especially the areas of patient 

recruitment for clinical trials or the integration of electronic data capture within 

the hospital environment are being explored. This session contains several case 

studies exploring this new field. 

Utilisation of Electronic Medical Records in Clinical Development 

Joseph Kim, Director, Site Feasibility and Patient Recruitment, 

ePharmaSolutions, USA 

EHR Use for Recruiting Patients on Oncology Trials 

Marc Cuggia, Department of Medical Information, University Hospital of Rennes 

and INSERM, France 

Integration in a Hospital Environment 

Christel Daniel, Pathologist, Associate Professor, Hôpital Européen Georges 

Pompidou, INSERM, France 


CONNECTING HEALTHCARE AND CLINICAL RESEARCH 


Philippe Verplancke, Managing Director, XClinical GmbH, Germany 

Healthcare and clinical research are intimately linked; however different work 

processes and information standards, as well as different regulatory 

environments make their integration challenging. In this session we will explore 

how we can make integration possible. 

Connecting Healthcare and Clinical Research - EHRCR Link 

Miguel A. Valenzuela, Head of Enterprise Systems QRM, Roche Products Ltd., 

UK 

Integration of Electronic Health Records (EHR) and Electronic Data Capture 

(EDC) Systems – A case study 

Wolfgang Summa, Executive Vice President, Business Development, 

OmniComm Systems, Germany 

Theme 12 

Pharmaceutical Sciences in 2020 


Geoff Tucker, Emeritus Professor of Clinical Pharmacology, University of 

Sheffield and UK Chairman, Simcyp Ltd., UK 

Hubert Leufkens, Professor Division of Pharmacoepidemiology & 

Pharmacotherapy, Utrecht Institute for Pharmaceutical Studies, The 

Netherlands 

The pharmaceutical sciences are likely to look very different in 10 years time. 

These sessions will peer into the crystal ball with respect to changes in research 

emphasis, enabling technology, paradigms for drug development, evaluation 

and regulation and the education of the workforce. 



WHAT MAJOR RESEARCH ACTIVITIES WILL DRIVE DRUG DISCOVERY AND 

DEVELOPMENT? 




By 2020, developments in target identification, systems biology, bioengineering 

and bioinformatics are likely to have transformed the pharmaceutical sciences. 

Perspectives will be provided from academia, industry and business 

development. 

Looking into the Academic Tea Leaves 

Malcolm Rowland, Emeritus Professor of Pharmaceutical Sciences, University of 

Manchester, UK 

What Will Tomorrow's Innovation Ecosystem Be for Biomedical R&D? 




WHAT WILL THE ENABLING TECHNOLOGIES BE? 


Daan Crommelin, Scientific Director, Top Institute Pharma, The Netherlands 

Basic science provides us with a plethora of new insights that may be drivers for 

innovation in the pharmaceuticals sciences. One can think of: the impact on 

therapeutic handling of ultrafast computing, tissue engineering/stem cells, noninvasive 

imaging, on-demand delivery/miniaturisation of monitoring/delivery 

equipment, robotics, enhanced and pervasive information technology for 

sharing knowledge. In three presentations a selection of these drivers will be 

discussed. 

The Role of Computers in the Pharmaceutical Sciences 2020 


Nanotechnology - Will the hope turn out to be hype? 

Daan Crommelin, Scientific Director, Top Institute Pharma, The Netherlands 

Advanced Technologies in 2009: What will have happened to them by 2020? 

Egbert Flory, Head of Tissue Engineering and Somatic Cell Therapeutics, Paul- 

Ehrlich-Institut, Germany 

Panel with Christian Schneider, Chair CAT, European Medicines Agency, Head, 

Division EU Cooperation/Microbiology, Paul-Ehrlich-Institut, Germany 


WHAT PARADIGM/GEOGRAPHICAL SHIFTS WILL THERE BE IN DRUG 

DISCOVERY/DEVELOPMENT? 


Vinod Shah, Scientific Secretary, International Pharmaceutical Federation (FIP), 

USA 

By 2020 a number of balances are likely to undergo further change – small 

companies in favour of large companies for discovery, while clinical 

development and marketing development will remain the province of large 

companies; more biologicals relative to small molecules; an increasing 

component of metabolomics relative to genetics in the drive for personalised 

medicine; and eastward global drifts in the brain gain/drain ratio. Climate 

change is also likely to have a significant impact on the complexion of drug

discovery and development. 


Pharmaceutical Sciences 2020 – Medicines of the Future 

Vinod Shah, Scientific Secretary, International Pharmaceutical Federation (FIP), 

USA 

Pharmaceutical Sciences 2020 – Business Models of the Future 

Mario Rocci, Executive Vice President, Icon Development Solutions, USA 

The Prospective Contribution and the Global and Integrated Approach to 

Pharmaceutical Industry’s New Challenges 

Catherine Frade, Director, AxeLPharm, France 


HOW WILL REGULATORS AND THE HTA COMMUNITY RECONCILE THE NEED 

FOR RAPID MARKET ACCESS WITH THE ASSESSMENT OF BENEFIT/RISK? 


Hubert Leufkens, Chairman of the Medicines Evaluation Board, The Netherlands 



There is growing awareness that granting a marketing authorisation for a new 

medicinal product is rather the beginning than the end in pharmaceutical 

innovation. First, a decision of approval is virtually always made under 

conditions of great uncertainty with respect to the benefit/risk of the product 

in real life practice; rapid access scenarios need post-approval studies to bridge 

this gap. Moreover, a new medicinal product will be increasingly subject to 

health technology assessment (HTA) in order to fuel evidence-based formulary 

and/or reimbursement decision making. This session will highlight the current 

scientific, regulatory and economic challenges and will address the various 

opportunities for collaboration and synergy between the different stakeholders. 

Is the Industry Ready to Embark on Rapid Access to New Medicines Scenarios? 

Ulf Janzon, Director External Affairs, Merck Sharp & Dohme, Sweden 

Rapid Access to New Medicines Given Uncertain Benefit/Risk from the 

HTA/Payers Perspective 

Albert Wertheimer, Director of the Center for Pharmaceutical Health Services 

Research at the School of Pharmacy, Temple University, USA 

Benefit/Risk Management throughout the Product Lifecycle as a Key to 

Sustainable Access to Medicines 

Hubert Leufkens, Chairman of the Medicines Evaluation Board, The Netherlands 



HOW WILL CHANGES IN EDUCATION MEET THE DEMANDS OF INDUSTRY 

AND REGULATION? 


Lyle Bootman, Dean and Professor, College of Pharmacy, University of Arizona, 

USA 

An overview of the reform of healthcare delivery reform that is occurring in the 

USA and globally will be followed by an assessment of the how this will impact 

educational needs and demands of academia (science and practice), industry 

and regulation to meet this paradigm shift at undergraduate, graduate and 

professional levels. 

Impact of Health Reform on Pharmacy Education 

Lyle Bootman, Dean and Professor, College of Pharmacy, University of Arizona, 

USA 

Theme 13 

Changes in Pharmaceutical Sciences Education: Needs and demands from 

Academia and Industry 

Jonathan Cooke, Director of Research and Development, Clinical Director for 

Medicines Management and Pharmacy, University Hospital South Manchester, 

UK 

Training for the Future: A Regulatory Perspective on the Future of Professional 

Education 

Gro Wesenberg, Director Medical Department, Medicines Agency, Norway 

Theme 13 

Clinical Trials and e-Submissions 




Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, 

Pfizer AB, Sweden 

This theme differs from the other themes in that it does not take a multidisciplinary 

view of a certain area. When developing the programme, it was 

noticed that a number of aspects related to clinical trials as well as to esubmissions 

would be of interest to cover and would thus merit inclusion, 

however not falling within any of the defined themes. Theme 13 is hence a mix 

of topics related to clinical trials and to e-submissions. The aim has been to 

capture aspects that might benefit a broader audience. 



IS THE EUROPEAN APPROACH TO IMPLEMENTATION OF THE ICH-GCP 

STANDARD KILLING CLINICAL RESEARCH? 


Ingrid Klingmann, Managing Director, Pharmaplex bvba, Belgium 

ICH-GCP was introduced 13 years ago with the intention to protect patients in 

clinical trials and to ensure acceptable quality standards in the global 

development of new treatments. The resulting European legislative framework 

for clinical trials combined the implementation of the GCP principles with the 

introduction of a system to harmonise the clinical trial performance in the EU 

Member States and to increase transparency in clinical research. In addition, 

national legislation, ethics committees and commercial sponsors felt obliged to 

further strengthen the adherence to these principles – everyone with own ideas 

and own rules. As a result, investigators are confronted with a flood of 

administrative requirements, different systems and approaches, minimising 

their capacity to recruit and retain patients in clinical trials or to organise most 

needed, scientifically sound treatment optimisation studies that are of no 

interest to the pharmaceutical industry. But also ethics committees and 

(especially) smaller Pharma companies feel unable to work at their best 

capability in the patients’ interest. It is high time to streamline the current 

European clinical trial process, to reduce duplication of efforts and to clarify 

distribution of responsibilities. This session will highlight the most critical areas 

and present solutions. 

Is the Current European Ethical Review Process Really in the Patients’ Best 

Interest? 

Jan Geissler, Executive Director and co-founder, European Cancer Patient 

Coalition (ECPC), Germany 

Does the Current Safety Reporting System in Clinical Trials Reduce Patients’ 

Risks in Clinical Trials? 

Nathalie Dubois, Head of Pharmacovigilance Unit, EORTC, Belgium 

Reduction of Bureaucracy in Clinical Trials – A proposal to rescue clinical 

research in Europe 

Ingrid Klingmann, Managing Director, Pharmaplex, Belgium 

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SIMPLIFICATION OF EU CLINICAL TRIALS FRAMEWORK: A POSSIBILITY? 


Mats Ericson, Regulatory Policy Director, Amgen, France 

This session aims to explore ways to reduce administrative burden and to 

streamline the regulatory supervision of clinical trials in the EU, shorter- and 

longer term. A recent initiative is the so called voluntary harmonisation 

procedure (‘VHP’). Learnings from the first year will be presented from the point 

of view of the Clinical Trials Facilitation Group and of a commercial sponsor, 

respectively 

Voluntary Harmonisation Procedure 

Harmut Krafft, Head, Clinical Trials Unit, Paul-Ehrlich-Institut, Germany 

Presentation title 

Stefan Führing, DG Enterprise, European Commission, EU 

Industry View 

Georgios Amexis, Global Regulatory Oncology/Regulatory Oncology EU I, 

Merck Serono KGaA, Germany 


eCTD – CONTINUING IMPLEMENTATION – FACTORS AFFECTING 


Andrew Marr, Director, Global e-Regulatory Development, Global Regulatory 

Operations, GlaxoSmithKline, UK 

The use of the eCTD is becoming more routine but many factors are affecting 

how it will be used. It is never static. The Centralised Procedure is most 

advanced with implementation and European Medicines Agency are looking to 

increase efficiency of handling. A new set of guidances from Switzerland have 

been issued to support implement the eCTD from 2010 and the new Variations 

regulations has impacts upon the way that eCTD will be used. 

eCTD in the Centralised Procedure – Where to from here? 

Tim Buxton, Head of Sector, Project Management, European Medicines Agency, 

EU 

Swissmedic’s Implementation of the eCTD 

Stephan Järmann, SIMES Project Manager, SwissMedic, Switzerland 

The Use of e-Submissions within the Context of the New Variations 

Regulations 

Geoff Williams, e-Regulatory Liaison, Regulatory Operations, Roche Products, 

UK 


TRANSPARENCY FROM CLINICAL TRIALS - ARE WE PATIENT-FOCUSED? 


Fergus Sweeney, Head of Compliance and Inspections, European Medicines 

Agency, EU 


Theme 13 - Hot Topics/Stand-Alone Sessions 



e-SUBMISSIONS IN MRP/DCP AND NATIONAL PROCEDURES: WHEN WILL 

ALL EU AUTHORITIES AND THE INDUSTRY SWITCH TO ELECTRONIC-ONLY? A 

PANEL DISCUSSION 


Karin Gröndahl, Head of Registration and Information Management, MPA, 

Sweden 

Not all the EU authorities are ready for electronic only submissions despite the 

HMA agreement of 2005 in Reykjavik which stated 31 December 2009 as the 

deadline. Why could this goal not be fully met? What are the plans for further 

development in this direction? Will the eCTD one day be mandatory for 

MRP/DCP? Industry often points out the problems with meeting the different 

national requirements of each NCA and also that NeeS will still be needed in the 

future. Why is the NeeS format chosen so often? What are the obstacles to 

submitting eCTDs in MRP/DCP and how should they be overcome? 

A panel of stakeholders from industry and EU authorities will discuss different 

issues on e-Submission within MRP, DCP and National Procedures and questions 

from the audience will be encouraged. 

Aginus Kalis, Director General, Medicines Evaluation Board, The Netherlands 

Miguel Bley, Chair of TIGes, London Bureau Representative European Medicines 

Agency, Afssaps, France 

Remco Munnik, Regulatory Affairs Information Manager, Sandoz B.V., The 

Netherlands 

Geoff Williams, e-Regulatory Liaison, Roche Products Ltd, UK 


EXPLORATORY CLINICAL TRIALS IN THE EU 


David Laurie, Regulatory Policy Expert, DRA Management, Novartis Pharma AG, 

Switzerland 

Requirements for Exploratory Clinical trials According to ICH M3 


Use of Exploratory Clinical Trials in Industry: When and how to take decisions 


Exploratory Clinical Trials: Experience from Regulatory Agencies 

Walter Janssens, Senior Assessor Pre-Clinical Department Research & 

Development, Federal Agency for Medicines and Health Products, Belgium 


MANAGING THE END-OF-PATENT FOR A MEDICINAL PRODUCT 


Elizabeth L. Coulson, Vice President, Pfizer Ltd., UK 


Latest News: 

The DIA is delighted to announce the addition of four sessions which will cover quality/CMC issues and their interaction with other pharmaceutical areas. These 

sessions (sessions 1602-1605) will take place on Tuesday, March 9, 2010. 

Details will be available as soon as possible on the DIA website.


Hot Topics/Stand-Alone Sessions 


16:30 Session 1401 

CONSEQUENCES OF SECTOR INQUIRY - UNDERESTIMATED BY THE 

BUSINESS? 


Anne N. Nielsen, Vice President and Senior Counsel, Europe and Asia Pacific, 

Bristol-Meyers Squibb, USA 


Session 1501 

NEW REQUIREMENTS FOR MISSING DATA HANDLING - A PROBLEM THAT 

AFFECTS EVERY SUBMISSION 


David Wright, Senior Statistical Assessor, MHRA, UK 


NON-CLINICAL SAFETY 


Gerd Bode, Consultant, Lecturer, University of Göttingen, Germany 

Session 1601 

This session will inform participants about the newest guidelines or revisions of 

implemented guidelines for the safety evaluation of small molecules and 

biotechnology-derived products. These presentations will be given by ICH Topic 

Leaders. 

ICH S6 – Revision of the Guideline for Biotechs 

Jennifer Sims, Head of Preclinical Development, Novartis Pharma AG, 

Switzerland 

ICH S2 – New Concepts for Genotoxicity Testing 

Peter Kasper, Scientific Director, BfArM, Germany 

ICH S9 – Strategies for Anticancer Pharmaceutical 

Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, 

Germany 

ICH M3 – New Recommendations for Timing and Patient Populations 




REGULATORY PERSPECTIVES ON COMBINATION PRODUCTS IN THE EU AND 

THE US 


Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical 

Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The 

Netherlands 

Combination products of drugs and devices are regulated by a mix of elements 

from both the pharmaceutical and medical device legislation. The composition 

of the 'regulatory mixture' for combination products differs in EU and US. This 

session will explain and highlight the philosophy and background of the 

relevant provisions of combination products in EU and US from a regulatory 

point of view. 

Combination Products in the EU: "Lost in Legislation"? 

Jos Kraus, Senior Inspector, Health Care Inspectorate, The Netherlands 


Notified Body: Passport to EU for Combination Products? 

Gert Bos, Head of Regulatory and Clinical Affairs, Healthcare, BSI, UK 

Office of Combination Products: The US Experience. 


Session 1602 

IMPLEMENTATION OF Q8, Q9 AND Q10: POINTS FOR FURTHER EXPANSION, 

DISCUSSION AND CLARIFICATION 


Fritz Erni, Consultant, Switzerland 

QbD Analytical Methods 

Matthias Pohl, Novartis Pharma AG, Switzerland 

Control Strategy/Batch Release Strategy 

Jacques Morenas, Associate Director, Inspection and Companies Department, 

Chairman of PIC/S, Afssaps, France 

Knowlegde Management 

Georges France, Vice President, Quality & Compliance Europe, EFPIA Topic 

Leader ICH Quality IWG, Wyeth Europa Ltd., UK 


PRACTICAL EXPERIENCES WITH BORDERLINE COMBINATION PRODUCTS 


Barry Burnstead, Consultant, Select CRO, UK 

Bringing a combination product to market possesses the challenges existing 

within both the drug and device worlds. What is the reality confronted by 

sponsors and how explicit are the regulations in providing a framework in which 

to succeed. This session will relate the practicalities experienced in three key 

areas of development. 

Optimising Development to Meet Global Regulatory Requirements 

Ian Purdy, Vice President Scientific Affairs, Boston Scientific, Ireland 

Ensuring Compliance in Safety Reporting on Combination Products 

Helena Van den Dungen, Global Head Drug Safety and Epidemiology Quality 

Assurance, Novartis Pharma AG, Switzerland 

Designing Clinical Programmes for Drug Device Combinations 


DRUG SUBSTANCE 


Diana Van Riet, Coordinator, Regulatory Affairs, RIVM, the Netherlands 


Session 1603 


EUROPEAN MEDICINES AGENCY ROAD MAPS 


Rolf Bass, Professor for Pharmacology and Toxicology, University Berlin- 

Charite, Germany, and University of Basel, Switzerland 

Achievements of the 2010 Road Map 

Thomas Lönngren, Executive Director, European Medicines Agency, EU 

Road Map to 2015 

Noël Wathion, Head of Patient Health Protection, European Medicines Agency, 

EU 

Industry 

Susan Forda, Vice President, International Regulatory Affairs, Eli Lilly, UK 

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14:00-15:00 Session 1504 

STUDENT SESSION in partnership with European Pharmacy Students 

Association (EPSA) & International Federation of Medical Students' 

Associations (IFMSA) 

DIVERSE CAREER PATHS – LOOKING BEYOND THE HOSPITAL/PHARMACY: A 

PANEL DISCUSSION 

Co-Chairs: 

Fokion Sinis, Vice President European Affairs, EPSA 

IFMSA Representative TBC 

The DIA in partnership with the European Pharmacy Students Association 

(EPSA) and the International Federation of Medical Students Associations 

(IFMSA) are hosting a panel discussion with experienced professionals who 

studied medicine/pharmacy and subsequently forged a successful career in the 

pharmaceutical profession. Each panellist will outline their career path into the 

pharmaceutical world and will discuss their current roles and responsibilities as 

well as how they see the profession changing in the future. This session aims to 

present to students the diverse range of options that the pharmaceutical 

profession can offer medical and pharmacy students. 

Brigitte Franke-Bray, European Director, Drug Information Association, 

Switzerland 

Truus Janse-De Hoog, Staff Member European Cluster, Medicines Evaluation 

Board, The Netherlands 

June Raine, Director, Division of Risk Management of Medicines, MHRA, UK 

Dagmar Stara, Faculty of Pharmacy, Comenius University in Bratislava, Slovakia 

VARIATIONS 


Keith Pugh, Assessor, MHRA, UK 



Session 1604 


REGULATORY IT STRATEGIES & STANDARDS BODIES- IS THERE A 

COALESCENCE? WHAT SHOULD THE NEXT INNOVATION BE TO ENHANCE 

PATIENT SAFETY? 


John Balian, Senior Vice President, Head of Global Pharmacovigilance & 

Epidemiology, Bristol-Myers Squibb, USA 

"Drug safety is a foundation of drug regulation," stated CDER Director, Dr. Janet 

Woodcock. Recent FDA guidances, press releases, and public pronouncements 

have made a point of making public its commitment to drug safety. The 

European Medicines Agency and the FDA have a broader vision for safety 

standards and surveillance. From potential changes in coding to SnoMed to the 

adoption of the HL7 (RIM) Reference information model, to the imposition of 

steep fines when REMS not implemented, an innovative model is needed for the 

industry to meet the increasingly challenging environment. 

REMs and RMPs in the Current Environment 

Amrit Ray,Chief Safety Officer, Johnson and Johnson, USA 

Drug Safety and Personalised Medicine: The role of Interoperability and 

Enterprise Architecture 

Charles Mead, Senior Director, Healthcare and Life Sciences Strategy, Booz Allen 

Hamilton, Chief Technology Officer, NCI, USA 

Signal Prediction in Early Development, Integrated Signal Detection 

throughout the Lifecycle 

Philippe Van der Auwera, Global Head of Safety Risk Management & EEA-QPPV, 


Session 1605 

SUBMITTING A QUALITY DOSSIER (MODULE 2 & 3) / E-SUBMISSION 


Christa Wirthumer-Hoche, Head, Unit for Marketing Authorisation and Lifecycle 

Management of Medicinal Products, AGES PharmMed, Austria 

Submitting Quality data, especially for QbD, in CTD is discussed. Specific 

guidance on e-CTD, in order to avoid pitfalls is given, as well as a general 

overview on the current situation on e-submissions in Europe from a regulatory 

point of view is presented. 

Concepts of CMC-Document Structure – Where to put QbD data 


Avoiding Pitfalls When Choosing CMC Attributes for eCTD Submissions 

(Module 2 & 3) 

Phyllis Thomas, CMC Documentation Advisor, Pharmaceutical & Analytical R&D, 

Astra Zeneca, UK 

e-Submissions – Where do we stand? Regulatory point of view 

Christa Wirthumer-Hoche, Head, Unit for Marketing Authorisation and Lifecycle 

Management of Medicinal Products, AGES PharmMed, Austria 



META-ANALYSIS FOR EVALUATION OF RISKS IN NEW TREATMENTS 


Joachim Vollmar, Executive Consultant, International Clinical Development 

Consultants LLC, USA 

Recently, the FDA issued a Guidance for Industry on "Evaluating Cardiovascular 

Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". It is requested 

that sponsors perform a meta-analysis of cardiovascular events across phase 2 

and 3 controlled clinical trials and explore similarities and/or differences in 

subgroups. Before submission of the NDA/BLA the incidence of important 

cardiovascular events occurring with the investigational agent and with the 

control group are to be compared. This session will describe the basic statistical 

concepts and implications, present the FDA's and European Agency's view and 

have a panel discussion with clinicians, pharmacovigilance experts and 

statisticians. 

Industry Perspective 

Jürgen Kübler, Global Head Integrated Safety & Health Economics Biostatistics, 

Novartis, Switzerland 

Evaluating Risks in New Treatments 


STUDY ENDPOINTS 



Session 1606 


HOW DO YOU ENSURE THERAPEUTIC EQUIVALENCE WITH SUFFICIENT 

CONFIDENCE? 


Jan Müller-Berghaus, Division of Immunology, Paul-Ehrlich-Institut, Germany 

Session under development



JAPANESE REGULATORY SESSION: PMDA UPDATE - INITIATIVES AND 

CHALLENGES FOR PROMOTING GLOBAL DRUG DEVELOPMENT 


Kyoichi Tadano, Director, Division of Planning and Coordination, PMDA, Japan 

In this session, you will hear a detailed review of the past year at PMDA as well 

as an overview of initiatives, milestones and current trends for the next year. You 

will hear directly from senior-level PMDA representatives on issues that may 

significantly affect your organisation’s regulatory operations 

Future Directions and Challenges of PMDA 

Tatsuya Kondo, Chief Executive, PMDA, Japan 

Current Status of New Drug Reviews and Challenges to Promote Global Drug 

Development 

Satoshi Toyoshima, Executive Director and Director, Center for Product 

Evaluation, PMDA, Japan 

Current Projects for Promoting Global Drug Development including Japan 



PRODUCT INFORMATION MANAGEMENT – PROGRAMME TO MOVE ALL 

PRODUCT INFORMATION IN THE CENTRALISED PROCEDURE TO PIM 


Steve Hasler, Vice President, Global Regulatory Operations, GlaxoSmithKline, 

UK 

The European Medicines Agency has issued a Statement of Intent regarding the 

migration of all product information to PIM format by the end of 2011. The use 

of PIM is strongly recommended for new products from mid-2010 and for 

authorised products from when the product information is migrated. A 

programme of work to achieve these goals is underway. 

European Medicines Agency Plans to Transition PIM to the Standard Way of 

Working 

Olivier Simoen, Head of Programme and Project Management, European 


The Process for Migration to PIM 

Mo Gould, Project Manager, FIT Consortium at the European Medicines Agency, 

EU 

Practical Experience of Migrations 

Lynsey Flitton, Senior Regulatory Labelling Manager, Global Regulatory Affairs, 

Wyeth Europa, UK 


DRAWING THE BORDERLINE BETWEEN MEDICINES AND OTHER 

CATEGORIES OF SELF-CARE PRODUCTS: A NEVER-ENDING TASK FOR 

REGULATORS IN EUROPE? 


Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, 

Belgium 

The session will review the regulatory requirements which apply in order to 

clarify certain borderline issues between medicinal products and other product 

categories, namely medical devices used in self-care, food supplements and 

cosmetics. Despite the provisions introduced by Directive 2004/27/EC to bring 

clarification in the area, differences in assessment between EU Member States 

remain frequent, resulting in a regulatory framework potentially uncertain for 

both industry and consumers. 

Latest Developments in the Borderline between Medicines and Food 

Lucca Battistini, Manager, Food Related Issues, AESGP, Belgium 


Borderline Medical Devices - Medical Products 

Peter Lassoff, Vice President, Europe, PAREXEL Consulting, UK 

Borderline Medical Products vs. Cosmetics 



PHARMACEUTICAL MEDICINE (IN COLLABORATION WITH IFAPP) 


Jean-Paul Deslypere, Business Development Manager, Life Sciences - Asia 

Pacific, SGS Life Sciences Services, Singapore 

Pharmaceutical Medicine (PM) can be defined as the discipline of medicine that 

is devoted to the discovery, research, development and support of ethical 

promotion and safe use of pharmaceuticals, vaccines, medical devices and 

diagnostics. Thanks to its important role in overseeing the process of 

developing new therapeutics it will greatly contribute at improving the 

standards of health and the quality of life within society. Although PM already 

has existed for more than 30 years it is still not well known within the medical 

profession and even amongst the clinical research community. This session aims 

to familiarise DIA participants with the specialisation of PM, and its professional 

representative groups: IFAPP and CEPM. The past and future achievements of 

IFAPP and CEPM will be highlighted as well as the major targets of these 

organisations: recognition of PM as a separate medical specialty and training of 

all involved in PM. For this, courses need to be set up and accredited, while 

participants who successfully finish the courses need to be certified. The 

experience with PM in the different continents will be discussed with 

contributions not only from very experienced countries but also from countries 

were PM is just organising itself. Last but not least some important future 

projects co-sponsored by the European Union authorities will be presented. 

IMI 16 

Fritz Buehler, European Center of Pharmaceutical Medicine, ECPM Executive 

Office, University Hospital Basel, Switzerland 

Pharmaceutical Medicine in Japan 

Stewart Geary, Vice President, Eisai Co. Ltd., Japan 

Pharmaceutical Medicine in China 

Frank Fan, Medical Director, Wyeth Ltd., China 

Session 1608 

THE FUTURE OF TELEMATICS IN EUROPE 

Session chair: 

Raun Kupiec, Senior Director regulatory Affairs – Process Management, 

Genzyme, Netherlands 

The importance of electronic interchange between applicant and regulator and 

between regulators increases month by month but where is it heading overall. 

The direction of the European Medicines Agency is laid out in the Telematics 

Master Plan but this needs to be regularly redefined as new drivers are 

identified. Industry is a key stakeholder in this but what direction does it feel 

should be taken and does it align with those defined by the regulators? The 

eCTD specification is under redevelopment and in time this may have a major 

impact on all stakeholders. Progress will be reported and future directions 

defined. 

The European Medicines Agency Telematics Master Plan – Continuing Progress 

Tim Buxton, Head of Sector, Project Management, European Medicines Agency, 

EU 

The Industry Vision for Telematics support for European Regulatory 

Procedures 

Steve Hasler, Vice President, Global Regulatory Operations, GlaxoSmithKline, 

UK 

eCTD Next Major Version – The European perspective 

Stan van Belkum, Programme Manager, Medicines Evaluation Board, The 

Netherlands 

43

Other Sessions 

44 



09:00 - 10:30 Session 1500 

STUDENT AND YOUNG PROFESSIONAL SESSION 1 

TRAINING AND JOB OPPORTUNITIES IN THE WORLD OF THE 

PHARMACEUTICAL INDUSTRY 


Sonja Pumplün, Vice President, Head Global Drug Regulatory Affairs, Actelion 

Pharmaceuticals Ltd., Switzerland 

Annette Mollet, Head, Training and Education, ECPM European Center of 

Pharmaceutical Medicine, University Hospital Basel, Switzerland 

Meet and exchange views with different key players in the healthcare system. 

Learn about different job profiles, continuing education and training 

possibilities to find a job in the pharmaceutical industry. Please join us and take 

the opportunity to discuss with experts who are involved in the process. 

Finding the Right Job in the Pharmaceutical Industry 

Detlef Niese, Head of External Affairs, Novartis Pharma AG, Switzerland 

Job Opportunities at the Health Authority 


European Postgraduate Training Platform 



11:00-12:30 Session 1600 

STUDENT AND YOUNG PROFESSIONAL SESSION 2 

HOW TO PRESENT AND SELL YOUR SKILLS 




Sonja Pumplün, Vice President, Head Global Drug Regulatory Affairs, Actelion 

Pharmaceuticals Ltd., Switzerland 

Please join us to hear from top specialists on how to brand yourself and best sell 

your skills by careful preparation for a job interview. How to improve your style 

and language skills to adapt to an international environment. You will have the 

opportunity to interact with experts from the healthcare industry. 

Brand Yourself 

Alex Khatuntsev, Human Resources Director, Actelion Pharmaceuticals Ltd., 

Switzerland 

Presentation Skills in English for Job Interview 

Judy Churchill, Director, Language Consulting Services, Ltd., UK 

How to Sell Yourself in an Interview 

Stephanie Zechner, Clinical Research Scientist, CTC Clinical Trial Consulting AG, 

Switzerland 



18:00 Session 1700 

AGENCY SATELLITE SESSION 

FOCUS ON SMALL AGENCIES AND SMALL MARKETS 

Session Chair 

Sif Ormarsdóttir, CHMP, European Medicines Agency, Clinical Assessor, 

Medicines Control Agency, Iceland 

The particular position and the challenges of small agencies are highlighted in 

presentations that address the pros and cons of being small in the current 

European regulatory environment. In what ways has the legislation of the 

European regulatory system benefited small agencies and how can small 

agencies cope with challenges in balancing between constantly growing 

national and EU needs? On the other hand, the mandate to contribute to the 

network, in particular to the European Medicines Agency activities is another 

source of set of challenges. Different solutions to fulfill the functions of an EU 

regulatory agency in 2010 are presented. The pharmaceutical industries 

experience with small agencies is presented. Drug availability in small markets 

is an issue and the role of small agencies and the responsibility of industry to 

improve the access of drugs are discussed. 

The Pros of Small Agencies 

John-Joseph Borg, PDCO, CHMP, European Medicines Agency, Post-Licensing 

Director, Medicines Authority, Malta 

The Cons of Being Small 

Romaldas Maciulaitis, CHMP, European Medicines Agency, State Medicines 

Control Agency, Lithuania 

The Industry Perspective on Small Agencies and Small Markets 

Gudrun Dóra Gísladóttir, Director Regulatory Affairs, Actavis, Iceland 

DIA Upcoming Training Courses 

Clinical Research 

Essentials of Clinical Study Management 

May 5-7, 2010 | Vienna, AUSTRIA 

November 10-12, 2010 | Lisbon, 

PORTUGAL 

Clinical Project Management in Europe – 

Part I 

February 10-12, 2010 | Paris, FRANCE 

Clinical Project Management in Europe – 

Part II 

September 22-24, 2010 | Basel, 

SWITZERLAND 

Practical GCP Compliance Auditing of 

Trials & Systems 

October 6-8, 2010 | London, 

UNITED KINGDOM 

Clinical Statistics for Non-Statisticians 

September 13-14, 2010 | Paris, FRANCE 

Regulatory Affairs 

Comprehensive Training on European 

Regulatory Affairs: Expert Overview 

January 24-26, 2010 | Dubai, 

UNITED ARAB EMIRATES 

CTD Dossier Requirements: Focus on EU 

Module 1 and Quality Module 3 

April 26-28, 2010 | Vienna, AUSTRIA 

December 5-7, 2010 | Dubai, 

UNITED ARAB EMIRATES 

European Regulatory Affairs: Review of 

Current Registration Procedures in the EU 

February 15-16, 2010 | Lisbon, PORTUGAL 

June 3-4, 2010 | Prague, CZECH REPUBLIC 

November 18-19, 2010 | Paris, FRANCE 

US Regulatory Affairs 

October 18-21, 2010 | Prague, 

CZECH REPUBLIC 

Good Management of Medical Devices 

April 26-28, 2010 | Paris, FRANCE 

October 27-29, 2010 | Geneva, 

SWITZERLAND 

Building the eCTD 


September 23-24, 2010 | Basel, 

SWITZERLAND 

An Introduction to Product Information 

Management (PIM) 

April 26-27, 2010 | Vienna, AUSTRIA 

October 28-29, 2010 | Geneva, 

SWITZERLAND 

Safety and Pharmacovigilance 

Excellence in Pharmacovigilance: Clinical 

Trials and Post Marketing 


October 25-29, 2010 | Vienna, AUSTRIA 

Practical Guide for Pharmacovigilance: 

Clinical Trials and Post Marketing 

June 2-4, 2010 | Prague, 

CZECH REPUBLIC 

December 1-3, 2010 | Paris, FRANCE 

Medical Approach in Diagnosis and 

Management of ADRs 

September 13-14, 2010 | Paris, FRANCE 

Introduction to Signal Detection and 

Data Mining in Pharmacovigilance 

April 26, 2010 | Paris, FRANCE 

October 7, 2010 | London, 


How to prepare for Pharmacovigilance 

Audits and Inspections 

April 27, 2010 | Paris, FRANCE 

October 8, 2010 | London, 


EudraVigilance Information Day 

June 22, 2010 | European Medicines 

Agency, London, 


October 19, 2010 | European Medicines 

Agency, London, UNITED KINGDOM 

Non-Clinical Sciences 

Non-Clinical Safety Sciences and Their 

Regulatory Aspects 

June 7-10, 2010 | Location to be confirmed 

November 22-25, 2010 | Location to be 

confirmed 

For more information and a complete listing of all training courses, please visit www.diahome.org 

and click on Conferences/Meetings or Training.

Exhibit at the 

EuroMeeting 2010 

46 

Exhibiting Companies as of 

December 11, 2009 

ACM Global Central Laboratory, United Kingdom 

Advanced Regulatory, United Kingdom 

Air Sea Containers Ltd., United Kingdom 

Akos Ltd., United Kingdom 

Almac, United States 

APC Pharmaceutical & Chemicals, United 

Kingdom 

Applied Clinical Trials, United States 

Aris Global Ltd., United Kingdom 

Averion International Corp., United States 

Axess Ltd.United Kingdom 

Barrington James, United Kingdom 

BaseCon A/S, Denmark 

Berzelius Clinical Research Center, Sweden 

BioKinetic, United Kingdom 

Biomedical Systems, Belgium 

BioStorage Technologies, United States 

C3i, Inc., Bulgaria 

Cambridge Regulatory Services, United Kingdom 

Cardiocore, United States 

Carefusion, Germany 

Catalent Pharma Solutions, United Kingdom 

CCBR-Synarc, France 

CCRA, United Kingdom 

CEMO S.A., France 

Chiltern, United Kingdom 

Choice Pharma, United Kingdom 

CIRION Clinical Trial Services, Inc., Canada 

Citysprint Medical Express, United Kingdom 

Clinical Professionals, United Kingdom 

Clinical Reference Laboratory, United States 

ClinIT AG, Germany 

ClinSource, Belgium 

CLS Communication AG, Switzerland 

CMIC Co., Ltd., Japan 

Comply Services, Belgium 

Covance, United Kingdom 

CRF Health, USA 

CROM Srl, Italy 

CROS NT, Italy 

Crown CRO OY, Finland 

CTC Clinical Trial Consulting, Switzerland 

DATAFARM, Inc., United Kingdom 

DATATRAK, United States 

DIA Fellowship, Switzerland 

Diapharm GmbH, Germany 

DOCS International, France 

Dora Wirth (Languages) Ltd., United Kingdom 

Showcase your company’s product or service to over 3,000 drug development professionals 

at the EuroMeeting 2010 in Monaco. 

Join over 200 exhibitors to interact with professionals from the pharmaceutical, biotechnology, 

devices, government, academia, healthcare delivery and related industries, from over 50 countries. 

For further information, please contact Natacha Scholl at the Drug Information Association in Europe: 

exhibition@diaeurope.org or call +41 61 225 5159 

DouleBridge Technologies, United States 

Drug Safety Research Unit, United Kingdom 

ECLINSO AG, Switzerland 

ENNOV-CLINSIGHT, France 

entimo AG, Germany 

Equateq, United Kingdom 

ERT, United States 

European Medicines Agency, United Kingdom 

Eurotrials, Portugal 

EXTEDO GmbH, Germany 

Glemser Technologies, United States 

Globex Courier GmbH, Germany 

Harlan Laboratories Ltd., Switzerland 

Harrison Clinical Research, Germany 

Hays Pharma, United States 

Imperial Clinical Research Services, Inc., USA 

INC Research, United States 

ISI Europe, Germany 

Kinapse Ltd., United Kingdom 

Lambda-Plus, Belgium 

LCG BioScience, United Kingdom 

Levy Associates Limited, United Kingdom 

Lionbridge Life Sciences, USA 

Liquent, USA 

Logica, Germany 

LORENZ Life Sciences Group, Germany 

MakroCare, India 

MedDRA MSSO, United States 

MedFiles Ltd., Finland 

Medicademy, Denmark 

Medicines Evaluation Unit, United Kingdom 

Medidata Solutions Worldwide, United States 

Medifacts International, Inc., United States 

NDA Group, Sweden 

NextDocs, United States 

NNIT, Denmark 

NOCRI, United Kingdom 

Nova Language Services, United Kingdom 

OCASA logistics Solutions, United States 

OmniComm Europe GmbH, Germany 

Online Business Applications, United States 

Oracle, United States 

Outcome, United States 

Oxford Outcomes, United Kingdom 

Paragon Biomedical, United States 

PAREXEL International & Perceptive Informatics, 

United States 

PFC Pharma Focus, Switzerland 

Pharmaceutical Development Services, United 

Kingdom 

Pharmaceuticals and Medical Devices Agency 

(PMDA), Japan 

PharmaForms, Germany 

PharmaNet Development Group, United Kingdom 

Pharmatching GmbH, Germany 

PharmaVigilant, USA 

Phase Forward, United Kingdom 

Phastar, United Kingdom 

PHT, United States 

Piramal Healthcare, United Kingdom 

Premier Research, United Kingdom 

Quality and Compliance Consulting, Inc., 

United States 

Quick STAT, United States 

Quintiles, United Kingdom 

Qumas, Ireland 

Real Pharma, Germany 

Regulatory Pharma Net, Italy 

Regulatory Resources Group, United Kingdom 

Richmond Pharmacology, United Kingdom 

RPS, Inc., United States 

Schema GmbH, Germany 

S-Clinica, Belgium 

SDL, United Kingdom 

SGS Life Science Services, France 

Small Planet Meetings, United Kingdom 

Sofus Stockholm Consulting AB, Sweden 

Stamford Consultants AG, Switzerland 

Sticares InterACT, The Netherlands 

Surrey Clinical Research Centre, United Kingdom 

Tarius, Denmark 

Tech Observer, United States 

The Catenion Academy, Germany 

The Clinical Trial Company, United Kingdom 

the Uppsala Monitoring Centre, Sweden 

Thomson Reuters, United States 

TOPRA, United Kingdom 

TransPerfect Translations, United States 

United BioSource Corporation, United States 

Vitalograph, United Kingdom 

WCI Consulting Limited, United Kingdom 

Wiley-Blackwell, United Kingdom 

Woodley Equipment Company Ltd., United 

Kingdom 

XClinical, Germany

About 

Monaco 

The Principality of Monaco may be one of the smallest countries in the world but 

it has an incredible amount to offer. Accessible, glamourous, and with DIA’s 

specially negotiated hotel rates, very affordable, Monaco is one of the world’s 

most attractive destinations. For three days in March 2010, Monaco’s 33,000 

inhabitants will be joined by 3,000 EuroMeeting participants. As all hotels are 

within walking distance of the Convention Centre, the 2010 EuroMeeting will have 

an intimate feel that maximises networking opportunities. With picturesque places 

to discover, sites to visit, museums, leisure facilities, shops and boutiques, and over 

150 restaurants, you may be very tempted to extend your trip. 

An international hub, easily accessible by air, road and rail, the Nice-Côte d’Azur 

International Airport is a 30-minute drive away, providing flights to more than 80 destinations 

throughout the world, and the new TGV railway centre is completely underground and links the 

town centre to the whole European rail network. 

Quick facts: 

Area: Approximately 2 square km (1 square mile) 

Location: Between the French and Italian Rivieras 

Climate: Sunny weather all-year round 

Languages: The official language of Monaco is French but English, Italian, as well as Monégasque (local language) are also spoken. 

Currency: The Euro 

Government: Constitutional monarchy. The Grimaldi family has ruled over Monaco since 1297. 

Discovering Monaco 

La Condamine is the port area. Monte Carlo is the main centre for business and entertainment where the famous 

Monte Carlo Casino is located. Monaco-Ville, the old city built on a rocky promontory extending into the 

Mediterranean, known as the Rock of Monaco, or simply Le Rocher (the Rock) is where the palace is located. For 

more information, please go to www.visitmonaco.com 

The Convention Centre 

The EuroMeeting will take place at the state-of-the-art Grimaldi Forum on the waterfront. This daylight-filled building 

with its stunning glass entrance is built on land reclaimed from the sea. It opened for conferences in September 

2000. 

Getting to Monaco 

By road 

The European motorway network which passes only 8km from the centre of town links the Principality to 

France, Spain, Italy, Switzerland, Germany, the Benelux countries, Austria and the UK. On leaving Nice airport, 

this network enables you to reach the Principality of Monaco, 22km away in less than 30 minutes, thanks to its 

own junction on one of the departmental coastal roads. 

Between Nice and Monaco, you can also take three highly attractive roads, the “Basse Corniche” (N98), along 

the coast, the “Moyenne Corniche” (N7), passing through Eze Village and the “Grande Corniche”, passing 

through La Turbie and Col d’Eze at an altitude of 512m. 

By rail 

All trains stop at the Monaco/Monte Carlo station. The TGVs to and from Paris (journey time 5.5 hours). Trains to Milan, Genoa or Basel during the day. 

Overnight trains to Strasbourg, Paris, Toulouse, Irun, Port-Bou, Milan, Venice, Pisa and Rome. Regional Express Trains which connect the towns on the Côte 

d’Azur. 

By plane 

The Nice Côte d’Azur International Airport links the Principality of Monaco to more than 86 worldwide destinations. The highlight of the Côte d’Azur, the 

Principality of Monaco, via Nice airport (30 minutes by road, or 7 minutes by helicopter transfer) is linked daily to major European capitals and beyond to all 

continents. Save Up to 20% on Airfare with the Star Alliance Network! See page 49 for details. 

Bus from Nice Côte d’Azur International Airport to Monaco 

DIA will provide a complimentary direct shuttle between Nice Côte d’Azur International Airport and DIA’s conference hotels in Monaco. To find out this and 

other discounted/complimentary transport offerings, please see page 49. 

47

Monaco - Surprisingly Affordable Hotel Rates! 

Monaco hotels are ranked as some of the best in the world. DIA has negotiated special conference rates which are very competitive in comparison to many 

other major cities in Europe. All rates include breakfast, service and all taxes. Double and single room rates are the same. 

Complimentary Shuttle Buses will run between Nice Côte d'Azur Airport and DIA’s conference hotels. Schedule details will be provided 

closer to the EuroMeeting. 

Please be advised that DIA has only one contracted and exclusive hotel agent for the EuroMeeting 2010: K.I.T. Group. 

DIA works with one agent to ensure that: 

• Your hotel reservations are officially part of the EuroMeeting. 

• The hotels rates have been individually negotiated for the EuroMeeting and are exclusive to EuroMeeting participants. 

• Your hotel reservations, privacy and personal data are completely secure. 

Hotel Name 

4 Star Palace 

Room Rate incl. breakfast 

and complimentary DIA airport 

shuttle to hotel 

Distance from hotel to Convention Centre 

Hôtel de Paris 265.00 € Walking distance 

Hôtel Metropole Monte-Carlo 270.00 € Walking distance 

4 Star Deluxe 

Hôtel Hermitage 209.00 € Walking distance 

Fairmont Monte-Carlo 203.00 € Walking distance 

Port Palace 213.00 € Walking distance 

Le Méridien Beach Plaza 203.00 € Walking distance 

Monte-Carlo Beach Hotel 199.00 € Walking distance 

Monte-Carlo Bay Hotel 199.00 € Walking distance 

3 Star Deluxe 

Columbus Monaco 203.00 € 10 minutes by bus (complimentary hotel shuttle to 

the Convention Centre in the morning and evening) 

3 Star 

Hotel Ambassador 170.00 € 5-10 minutes by bus 

Novotel Monte-Carlo 185.00 € Walking distance 

48 

Book your hotel room by 

December 4, 2009 

and get the chance to win two VIP 

tickets for the Monaco Formula One Grand Prix 

(Sunday, May 16, 2010) 

Book your hotel room through the EuroMeeting website and you 

may have a good reason to come back in May! The Grimaldi 

Forum Convention Centre, in partnership with the Monaco 

Convention Bureau, is offering you the chance to win the fantastic 

and exclusive prize of two tickets in their Monaco Grand Prix VIP 

private stand, including a welcome cocktail and lunch, if you book 

your hotel room through the EuroMeeting website by December 

4, 2009 (17:00 CET). All conference participants who have 

booked their room by that date will be automatically entered into 

the draw.

Monaco 

Tours 

Tour One: Royal Monaco 

Monday, March 8, 2010, 9am-1pm, EUR 63 per person including admittance to the Oceanographic Museum 

Enjoy a walk through the narrow streets of the old town discovering how this small land became a Principality. 

You will visit the Oceanographic Museum, which was built in 1910 by Albert, 1st Prince of Monaco and a great 

scientist of his time. This museum was for a long time directed by Jacques Cousteau. Strolling towards the 

cathedral, the Saint Martin gardens planted in 1830s offer a panoramic view over the Principality. The cathedral 

is a neo Romanesque construction built in 1875, surrounded by the court house and the national council 

bordering the square overlooking the sea. The Cathedral is where many of the Grimaldi Family are buried, 

including Princess Grace and more recently, Prince Rainer III. Our steps lead us in front of the palace where the 

changing of the guards takes place every day. On both sides of the palace, there are spectacular views over the 

port, Fontvieille and the Mediterranean coast. 

This tour includes an opening panoramic bus tour and admittance to the Oceanographic Museum. 

Make the most of your stay in Monaco and meet other 

EuroMeeting participants by reserving a place on one of our 

Monaco tours which are exclusive to EuroMeeting attendees and 

their partners/companions. 

Tour Two: Glamorous Monte Carlo Walking Tour 

Tuesday, March 9, 2010, 2pm-6pm, EUR 38 per person including admittance to the Monte Carlo Casino and Car 

Museum 

Enjoy a walk through the narrow streets of the old town discovering how this small land became a Principality. You 

will visit the Oceanographic Museum, which was built in 1910 by Albert, 1st Prince of Monaco and a great scientist 

of his time. This museum was for a long time directed by Jacques Cousteau. Strolling towards the cathedral, the 

Saint Martin gardens planted in 1830s offer a panoramic view over the Principality. The cathedral is a neo 

Romanesque construction built in 1875, surrounded by the court house and the national council bordering the 

square overlooking the sea. The Cathedral is where many of the Grimaldi Family are buried, including Princess 

Grace and more recently, Prince Rainer III. Our steps lead us in front of the palace where the changing of the guards 

takes place every day. On both sides of the palace, there are spectacular views over the port, Fontvieille and the 

Mediterranean coast. 

This tour includes an opening panoramic bus tour and admittance to the Oceanographic Museum. 

How to Book: 

Book online on the EuroMeeting 2010 website. Go to www.diahome.org and click on the EuroMeeting icon. Please contact 

Stephanie Kiewitz (K.I.T. Group) at dia2010-tours@kit-group.org with any questions. 

49

50 

Networking 

Opportunities 

Networking is an integral part of the EuroMeeting. Attendees tell us that the networking 

opportunities presented by the EuroMeeting are one of the key reasons for attending. 

Each year, the EuroMeeting offers numerous opportunities to catch up with existing 

contacts and to make new ones in a relaxing setting. All networking events at the 

EuroMeeting are included in the registration fee. 

The Mediterranean Reception 

Monday, March 8, 2010, 18:30-20:00 at the Fairmont Hotel 

Held at our headquarters hotel, the Fairmont, the Mediterranean Networking Reception is an 

excellent opportunity to renew your existing contacts and to make new ones. Beer, wine and soft 

drinks will be served with a wide range of delicious canapés. Enjoy the spectacular sea view. A restaurant 

booking desk will be available to assist with making post-reception dinner reservations. Partner tickets are 

available at the registration desk at the Grimaldi Forum for € 35 including VAT. 

Student and Young Professional Networking Lunch 

Monday, March 8, 2010, 12:45-13:45 

An opportunity for student and young professionals to network with their peers in a relaxed environment. 

DIA Special Interest Area Communities (SIACs) – Meet and Eat 

Tuesday, March 9, 2010, 12:30-13:15 

An opportunity for all SIAC members – and those interested in joining one – to get together for a networking lunch. DIA Europe’s Volunteer Service 

Coordinator will be on hand to answer any questions. 

Speed Networking Session 

Tuesday, March 9, 2010, 13:30-14:00 

All participants in the EuroMeeting try to use it as an opportunity to network. It is not easy to walk right up to someone, introduce yourself and have a 

conversation. The EuroMeeting Speed Networking session aims to make this process a lot easier. 

Speed networking, which is actually based on the original concept of speed dating, brings together individuals who are attending a conference. It will help 

you to make new contacts and intensify your networking experiences. The goal is to ensure that each participant will make at least six new professional 

contacts during the speed networking sessions. 

Tuesday Reception 

Tuesday, March 9, 2010, 17:30-18:30 

You won’t have to go far to enjoy the Tuesday Reception held on the Exhibition Floors at the Grimaldi Forum. A restaurant booking desk will be available to 

assist with making post-reception dinner reservations. Partner tickets are available at the registration desk at the Grimaldi Forum for € 15 including VAT. 

Network on the Exhibition Floor 

In response to attendee feedback, the Exhibition Floor is open even longer for the EuroMeeting 2010 in Monaco. Attendees now have the opportunity to visit 

the Exhibition Floor before sessions start with the doors opening at 8am on Tuesday and Wednesday. All refreshments will be served on the Exhibition Floor 

making it the ideal place to meet the people you want to meet. 

Specially Targeted Networking Activities 

DIA Europe has developed a programme of activities to facilitate networking for patients representatives, students and young professionals. 

Making your Meeting Affordable 

Discounted and Complimentary Services 

• All networking events are included in the registration fee 

• Heavily discounted hotel rooms offered. See page 46 and 49 for further details 

• Complimentary DIA airport shuttles

Discounted 

and Complimentary 

Transportation 

Offers 

Booking office information can be found at www.staralliance.com/conventionsplus. 

Discounted Airfares 

The Star Alliance member airlines are the official airline network for the 22nd Annual 

EuroMeeting. 

Simply call the reservation office of any participating Star Alliance member airline and 

quote the event code SK02A10. Registered participants plus one accompanying person 

travelling to the event are automatically granted a discount of up to 20%, depending on the 

class of travel. 

Participating airlines include: 

• ANA • Adria Airways 

• Austrian Airlines • Blue1 

• bmi • Croatia Airlines 

• EgyptAir • LOT Polish Airlines 

• Lufthansa • SWISS International Air Lines 

• Scandinavian Airlines • Spanair 

• TAP Portugal • Turkish Airlines 

• United Airlines 

Discounts are offered on published business and economy class fares, excluding website/internet fares, senior and youth fares, group fares and Round the 

World fares. 

NOTE: For travel from Japan and New Zealand, special fares or discounts are offered by the participating airlines on their own network. 

Complimentary DIA airport transfer shuttle service 

DIA will operate complimentary shuttle bus services between Nice Côte d'Azur Airport and the conference hotels in Monaco from Sunday to Wednesday. The 

shuttles will run every 30 minutes from Sunday to Tuesday and every 15 minutes on Wednesday. There will be a welcome desk at each terminal to offer advice 

and help. More details, including a schedule of services, will be made available closer to the EuroMeeting. 

Discounted Airport Transfer Services 

We hope you will choose the greenest option and make use of our complimentary shuttle service. However, we understand 

that our participants may want to make use of other types of transportation. DIA has negotiated special rates (over 10% 

discount) with Nizza Travel. Click here for information on booking a discounted private car transfer between Nice Côte d’Azur 

Airport and Monaco. Travel time is approximately 40 minutes. 

If you want to arrive in style, opt for a helicopter transfer. DIA has negotiated discounts with HeliAir Monaco who provide 

regular airlinks between Monaco and Nice Airport. Flying time is 7 minutes. A private shuttle will bring you comfortably to 

any place of your choice in Monaco in only 5 minutes. 

Special EuroMeeting Rates 

• Nice to Monaco € 100 

• Monaco to Nice € 85 

• Round trip ticket € 175 

To enjoy these special rates, please contact Fabien Garavagno at +377 92 050 033 / Fax +377 92 050 036 or fabien@heliairmonaco.com 

You can also visit www.heliairmonaco.com for more information. 

Complimentary local bus service in Monaco 

DIA’s conference hotels are within walking distance of the Grimaldi Forum. However, if you want to move around in Monaco, you can use local buses services 

for free just by showing your EuroMeeting badge. 

51


Session 1 

16:30 - 18:00 

Reception 18:30-20:00 


Session 2 

09:00 - 10:30 

Coffee Break 

Session 3 

11:00 - 12:30 

Lunch 

Session 4 

14:00 - 15:30 

Coffee Break 

Session 5 

16:00 - 17:30 


Session 6 

09:00 - 10:30 

Coffee Break 

Session 7 

11:00 - 12:30 

Lunch 

Session 8 

14:00 - 15:30 

52 

DIA 22nd Annual EuroMeeting 2010 at a Glance 

Theme 1 Theme 2 Theme 3 Theme 4 Theme 5 

Innovation 

Session 0101 

The Innovative Medicines 

Initiative 

Session 0102 

Is an Open Innovation Paradigm 

the Way Forward for Pharma? 

Session 0103 

The Importance of Pre- 

Competitive Data Sharing to 

Accelerate Drug Development 

Session 0104 

What is an Innovative Medicine? 

Session 0105 

Innovation in Early and Late 

Phase Clinical Trials I 

Session 0106 

Innovation in Early and Late 

Phase Clinical Trials II 

Session 0107 

Have the Benefits of 

Translational Medicine Been 

Realised? 

Session 0108 

Innovation to Reduce Attrition 

Staying in Business: How to 

make sure you comply with all 

rules and regulations, quality, 

compliance and external 

challenges 

Session 0201 

Transparency: A Pandora’s Box 

or a Panacea? 

Session 0202 

The Price of Globalisation: 

Bringing modern therapies to 

developing countries or only 

including patients in trials? 

Session 0203 

The Price of Globalisation: The 

costs, benefits, risks and pitfalls 

when moving development and 

manufacturing to Latin America 

Session 0204 

Counterfeiting: Who owns the 

problem? Who is in control? 

Session 0205 

Misuse of Medicines and Doping: 

What is the problem, how big is 

the problem? 

Session 0206 

Quality Risk Management: Myth, 

promise or a solution to the 

operational challenges of clinical 

development and regulatory 

compliance? 

Session 0207 

CTTI (Clinical Trial 

Transformation Initiative): What 

has been achieved, has it already 

delivered on the expectations 

raised? 

Session 0208 

Governance Challenges When 

Managing Partners Such as CROs 

and Licensing Partners 

Paediatric Medicines on their 

Way to Patients 

Session 0301 

Regulatory Challenges and 

Experience with New Paediatric 

Requirements 

Session 0302 

Design and Conduct of Ethical 

Paediatric Clinical Programs 

Session 0303 

Focusing on Pharmacovigilance 

and Safety Aspects of Paediatric 

Trials 

Session 0304 

Paediatric Development - Is a 

global strategy achievable? 

Session 0305 

Paediatric Formulations- Will 

they reach the market? 

Session 0306 

Harmonised Regulatory 

Expectations for Juvenile Animal 

Testing? 

Session 0307 

Challenges under the Paediatric 

Regulation to Obtaining the SPC 

Extension 

Session 0308 

Initial Impact of the Paediatric 

Regulation after 3 years 

Decision Making: The key to 

efficient and effective drug 

development, approval and 

access 

Session 0401/1001 

Patient Influence on Regulatory 

Decisions: How much do they 

and should they have? 

Session 0402 

Transparency and Related 

Safeguards 

Session 0403 

Conditional Approvals: How to 

Strike the Right Balance between 

Early Access, Patient Safety and 

Commercial Reality 

Session 0404 

Clinical Trials: The Demise of 

Traditional Surrogate Markers? 

How to Create New Markers? 

Paving the Way for 

Therapies- Foster 

generations of biote 

derived medic 

Session 05 

CAT Experience in th 

Session 05 

ATMP Border 

Session 05 

ATMPs and Biother 

Do they require ch 

established qua 

manufacturing co 

Session 050 

Impact of New The 

Pre-Clinical Res 

Session 0405 

The True Value of Risk 

Session 05 

Management for Decision Making Clinical Resea 

and for Post-Approval New Therapies - New 

Commitments 

Session 0406 

The Benefit/Risk Assessment of 

Medicines in the Approval 

Process: Developing a Structured 

Approach to Decision Making? 

Session 0407/0807 

Influence of HTA on Regulatory 

Decision Making: Reality? An 

Opportunity? A Threat? 

Session 0408 

Company Decision Making 

during Drug Development 

Session 050 

Biosimilars- F 

Developments and 

Challenge 

Session 05 

Advanced Therapies 

Devices – Living with 

Management re 

Session 05 

Health Technology A 

- Are they possible fo 

therapies?

Advanced 

ing new 

chnologyines 

01 

e First Year 

2 

lines 

3 

apeutics – 

anges to 

ity and 

ncepts? 

4 

rapies on 

earch 

5 

rch: 

Challenges 

6 

ture 

egulatory 

s 

7 

and Medical 

a new Risk 

ality? 

8 

ssessments 

r advanced 

Theme 6 Theme 7 Theme 8 Theme 9 Theme 10 T 

Challenges for Switching from 

Prescription to Non-Prescription 

Status through the Centralised 

Procedure 

Session 0601/0901 

Risk Management for Switch 

Products 

Session 0602 

Are the Incentives Provided in 

Legislation Sufficient to Boost 

Innovation at the EU level? 

Session 0603 

Switching Trends: 

Evolution or revolution? 

Session 0604 

‘Central Switches’ – Where are 

we going ? 

Session 0605 

Could the UK Model Be 

Reproduced at the EU level ? 

Session 0606 

Impact of the EU Decision on 

Non-Prescription Status at the 

National Level 

Session 0607 

Information to 

Patients/Consumers: Fit for 

Purpose? 

Session 0608 

New Chance for Well-known 

Substances: CP or MRP/DCP 

PLENARY 13:30-16:00 

Personalised Medicines 

Session 0701 

Personalised Medicines: What is 

it, where do we stand and where 

are we going? 

Session 0702 

Is Europe Adapted to 

Personalised Medicines? What 

Needs to Change over the Next 

10 Years? 

Session 0703 

One Medicine Does Not Fit All. 

What Has Worked and What Can 

We Learn? 

Session 0704 

Biomarker Qualification Process - 

How does it work and where 

does it fit? 

Session 0705 

Efficacy: Evidence & study 

designs in Personalised 

Medicines 

Session 0706 

Safety: Evidence & study designs 

in Personalised Medicines 

Session 0707 

Diagnostics – If this is such a 

crucial element of the whole 

field, what are we doing to 

support, encourage and protect 

the diagnostics field? 

Session 0708 

International Regulatory 

Frameworks – Converging or 

diverging? 

Taking the European Regulatory 

Infrastructure Forward 

Session 0801 

Pharmaceutical Package- The 

Latest Information 

Session 0802 

International Co-operation 

between Regulatory Agencies 

Session 0803 

Heads of Medicines 

Agencies 

Session 0804 

Simultaneous Global 

Development: Present hurdles, 

future considerations and 

opportunities 

Session 0805 

CHMP Overview 

Session 0806 

Dialogue and Scientific Advice: 

Achieving Goals and Making it 

Happen 

Session 0407/0807 

Influence of HTA on Regulatory 

Decision Making: Reality? An 

Opportunity? A Threat? 

Session 0808 

Changes in Regulatory Agencies 

Meet Future Challenges 

Risk Management The Informed Patient e 

Session 0601/0901 

Risk Management for Switch 

Products 

Session 0902 

Regulatory Developments in Risk 

Management in the EU and US 


Non-Clinical Support to Aid Risk 

Management in Early Phase 

Studies 


When Do Adverse Events Qualify 

as Undesired Effects? 


Research and International 

Initiatives in Risk Management 


Performance, Quality Control and 

Audit in Pharmacoviglance and 

Risk Management 


Risk Minimisation- Is it Worth the 

Pain? 


Pandemic Vaccines 

Session 0401/1001 

Patient Influence on Regulatory 

Decisions: How much do they 

and should they have? 

Session 1002 

Pharmaceutical Package: 

Information to Patients Proposals 

– What difference will they 

make? 


Communication of Information 

on Medicinal Products (1) – How 

can a balance be achieved 

between legal restrictions and 

patient expectations? 


Communication of Information 

on Medicinal Products (2) – 

Factors to consider to ensure 

optimum accessibility and 

understanding 


Are Informed Patients Cost- 

Effective? How to ensure that 

patients understand the 

decisions being made on their 

medicines 


How Involved Can Informed 

Patients Be in the Development 

and Commercialisation of 

Medicines? 


Patient Use of Information on 

Medicinal Products 


What Information Do Patients 

Want on Medicinal Products and 

How Far Do the Current 

Provisions Go To Meet These 

Needs? 

Se 

The New IT 

Meeting t 

e 

Ses 

Patient and 

Outcomes Us 

Product Deve 

on industry 

regul 

53 

Ses 

EDC C 

Ses 

Emerging 

Optimisa 

Tr 

Ses 

Improving D 

the Use of 

Ses 

Healthcare 

St 

Ses 

Utilisation of 

Records in C 

Ses 

Connectin 

Clinic

heme 11 Theme 12 Theme 13 

Health 

sion 1101 

Architecture for 

e Challenges of 

Health 

sion 1102 

Clinician Reported 

e in Global Medical 

lopment: An update 

best practice and 

atory issues 

sion 1103 

ase Studies 

sion 1104 

Technologies for 

tion of Patient 

eatment 

sion 1105 

rug Safety through 

ew Technologies 

sion 1106 

Interoperability 

andards 

sion 1107 

Electronic Medical 

linical Development 

sion 1108 

g Healthcare and 

al Research 

Pharmaceutical Sciences in 

2020 

Session 1202 

What Major Research Activities 

Will Drive Drug Discovery and 

Development? 

Session 1203 

What Will the Enabling 

Technologies Be? 

Session 1204 

What Paradigm/Geographical 

Shifts Will There Be in Drug 

Discovery/Development? 

Session 1205 

How Will Regulators and the HTA 

Community Reconcile the Need 

for Rapid Market Access with the 

Assessment of Benefit/Risk? 

Session 1206 

How Will Changes in Education 

Meet the Demands of Industry 

and Regulation? 

Clinical Trials and eSubmission Hot Topics 

Stand Alone Sessions 

Session 1302 

Is the European Approach to 

Implementation of the ICH-GCP 

Standard Killing Clinical 

Research? 

Session 1401 

Consequences of Sector Inquiry - 

Underestimated by the Business? 

Session 1402 

Regulatory Perspectives on 

Combination Products in the EU 

and US 

Session 1303 

Session 1403 

Simplification of EU Clinical Trials Practical Experiences with 

Framework: A Possibility? Borderline Combination Products 

Session 1304 

eCTD – Continuing 

Implementation – Factors 

affecting 

Session 1305 

Transparency from Clinical Trials- 

Are we patient focused? 

Session 1306 

e-Submissions in MRP/DCP and 

National Procedures 

Session 1307 

Exploratory Clinical Trials in the 

EU 

Session 1308 

Managing the End-of-Patent for 

a Medicinal Product 

Session 1404 

European Medicines Agency 

Road Maps 

Session 1405 

Regulatory IT Strategies & 

Standards Bodies- is there a 

coalescence? What should we 

read between the lines? 

Session 1406 

Meta-analysis for Safety 

Assessment - Current trends and 

guidances 

Session 1407 

How to Ensure Therapeutic 

Equivalence with Sufficient 

Confidence? 

Session 1408 

Drawing the Borderline between 

Medicines and Other Categories 

of Self-Care Products: A neverending 

task for regulators in 

Europe? 

Session 1501 

New requirements for missing 

data handling - a problem that 

affects every submission 

Session 1503 

Patient Skills Working Lunch 

12:45 -13:45 

Session 1504 

Student Special Session 

Session 1505 

Agency Satellite Session 

18:00-19:30 

Session 1507 

Japanese Regulatory Session 

Session 1508 

Pharmaceutical Medicine 

Session 1601 

Non-Clinical Safety 

Session 1602 

CMC/Quality Session 

under development 

Session 1603 



Session 1604 



Session 1605 



Session 1606 

Study Endpoints 

Session 1607 

PIM 

Session 1608 

The Future of Telematics in 

Europe 

54

55 


EuroMeeting Key Contacts 

Go to the EuroMeeting website (www.diahome.org and click on the EuroMeeting icon) for up-to-the-minute information, to register for 

the EuroMeeting or for a pre-conference tutorial, to download the programme and to book hotel rooms and tours. 

Accounting Queries 

For accounting inquiries please contact Suzanne de Zilva at suzanne.dezilva@diaeurope.org or +41 61 225 51 50 

Advertising Opportunites 

Enquiries should be directed to Frank Vivian at fvivian@ki-lipton.com or +1 267 893 56 75 

Exhibitors 

Enquiries from exhibiting companies or enquiries regarding the product locator, company summary book, exhibitor mailings, exhibitor 

kiosk and/or hospitality suites should be directed to Natacha Scholl at exhibition@diaeurope.org or +41 61 225 51 59 

Press Passes/Press List/Press Release Programme 

All enquiries regarding press passes and/or press lists should be directed to Talana Bertschi at talana.bertschi@diaeurope.org or 

+41 61 225 51 49 

Registration Queries 

For attendees with last names A-M please contact Roxann Schumacher at roxann.schumacher@diaeurope.org or +41 61 225 51 38 

For attendees with last names N-Z please contact Simona Ponzer at simona.ponzer@diaeurope.org or +41 61 225 51 69 

Speakers/Session Chairs 

Enquiries from speakers should be directed to Sharon Evans Schuler at sharon.evans@diaeurope.org or +41 61 225 51 44 or Maureen 

McGahan at maureen.mcgahan@diaeurope.org or +41 61 225 51 60 

Poster Presenters and DIA EuroMeeting Fellowships 

Further information is available from Maureen McGahan at maureen.mcgahan@diaeurope.org or +41 61 225 51 60 

General Queries 

For all other queries or for unresolved issues, please contact Dermot Ryan, Senior Event Manager (EuroMeeting) 

at dermot.ryan@diaeurope.org or +41 61 225 51 32 

DIA is committed to the active participation of students in the EuroMeeting and offer a special EUR 100 (+VAT) student rate. Please 

contact DIA Customer Services on +41 61 225 5151 to register for this rate. 

Latest News: 

The DIA is delighted to announce the addition of four sessions which will cover quality/CMC issues and their interaction with other pharmaceutical areas. 

These sessions (sessions 1602-1605) will take place on Tuesday, March 9, 2010 and are currently being developed by Jean-Louis Robert, Head, 

Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg, Christa-Wirthumer-Hoche, Head of Institute, Deputy Head of 

PharmMed, AGES PharmMed, Austria, Fritz Erni, former Head Technical Liaison, Group Quality Operations at Novartis, Pharma AG, Switzerland, Dr. 

Georges L France, Vice President, Quality & Compliance Europe, EFPIA Topic Leader ICH Quality IWG, Wyeth Europa Limited, UK 

Details will be available as soon as possible on the DIA website.

REGISTRATION FORM ID# 10101 

22nd Annual EuroMeeting Monaco 2010 

March 8-10, 2010 - Grimaldi Forum, Monaco 

If DIA cannot verify your membership upon receipt of registration form, you will be charged the non-member fee. 

Early-Bird rates available for Members: 

Deadline on or before January 18, 2010 

Join DIA now to qualify for the early-bird member fee! To qualify for the early-bird 

discount, registration form and accompanying payment must be received by the date 

above. Does not apply to government/academia/non-profit members 

Early-Bird Fee 

(on or before January 18, 2010) FEE VAT 19.6% TOTAL 

Join DIA now to qualify for the Early-Bird Rate € 115.00 n/a € 115.00 � 

Early-Bird Industry € 1’625.00 € 318.50 € 1’943.50 � 

CATEGORY MEMBER (after January 18, 2010) NON-MEMBER (with optional membership) NON-MEMBER (without optional membership) 

FEE VAT 19.6% TOTAL FEE VAT 19.6% Membership TOTAL FEE VAT 19.6% TOTAL 

Industry € 1’780.00 € 348.88 € 2’128.88 � € 1’780.00 € 348.88 € 115.00 € 2’243.88 � € 1’895.00 € 371.42 € 2’266.42 � 

Charitable/Non-profit/Academia (Full-Time) € 1’335.00 € 261.66 € 1’596.66 � € 1’335.00 € 261.66 € 115.00 € 1’711.66 � € 1’450.00 € 284.20 € 1’734.20 � 

Government (Full-Time) € 890.00 € 174.44 € 1’064.44 � € 890.00 € 174.44 € 115.00 € 1’179.44 � € 1’005.00 € 196.98 € 1’201.98 � 

Monday, March 8, 2010 Please indicate the tutorial number you wish to attend _____________ 

Tutorial Fee € 370.00 € 72.52 € 442.52 � (see page 11-16 for full description of the tutorials) 

TOTAL AMOUNT DUE: € __________________________ NOTE: Payment due 30 days after registration and must be paid in full by commencement of the event 

STUDENT AND GROUP DISCOUNTS RATES ARE AVAILABLE! PLEASE CONTACT DIA FOR MORE INFORMATION 

REGISTRANT 

PLEASE COMPLETE IN BLOCK CAPITAL LETTERS OR MAKE REGISTRATION EVEN 

SIMPLER BY ATTACHING THE REGISTRANT’S BUSINESS CARD HERE 

� Prof. � Dr. � Ms. � Mr. 

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TO MAKE REGISTRATION EVEN 

SIMPLER, PLEASE ATTACH THE 

REGISTRANT’S BUSINESS CARD HERE 

IMPORTANT: Hotel and travel reservations should be made ONLY after receipt of written registration confirmation from DIA. 

If you have not received your confirmation within five working days, please contact the DIA in Europe. 

HOW TO REGISTER 

Online www.diahome.org Fax +41 61 225 51 52 

Email diaeurope@diaeurope.org 

DIA European Office, Elisabethenanlage 25 

Postfach, 4002 Basel, Switzerland 

All registrations received at the DIA European Office by 18:00 CET on February 2, 2010, will be included in the Attendee List. 

Mail 

10101DIAWEB 

PAYMENT METHODS - CREDIT CARD PAYMENT IS PREFERRED 

� Please charge my credit card - credit card payments by VISA, Mastercard or AMEX can be 

made by completing the relevant details below. Please note that other types of credit card 

cannot be accepted. 

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� Cheques should be made payable to: D.I.A. and mailed together with a copy of the 

registration form to facilitate identification to: 

D.I.A., Elisabethenanlage 25, Postfach, 4002 Basel, Switzerland 

� Bank transfers: When DIA completes your registration, an email will be sent to the address on 

the registration form with instructions on how to complete the bank transfer. Payments in 

EURO should be addressed to “Account Holder: DIA.” including your name, company, Meeting 

ID# 10101 as well as the invoice number to ensure correct allocation of your payment. 

Payments must be net of all charges and bank charges must be borne by the payer. 

Bank transfers will not be accepted after February 5, 2010. 

Persons under 18 are not allowed to attend DIA meetings. 

CANCELLATION POLICY 

All cancellations must be in writing and received at the DIA office by 17:00 CET on February 26, 2010 

Cancellations received by the date above are subject to an administrative fee: 

Full Meeting Cancellation: Industry (Member/Non-member) = € 200.00 Government/Academia/Non-profit (Member/Non-member) = € 100.00. Tutorial cancellation: € 50.00. Registrants who do not 

cancel by the date above and do not attend, will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel reservations. DIA reserves the right to alter the 

venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registrants. 

Transfer Policy 

You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if 

applicable. Please notify the DIA office of any such substitutions as soon as possible. 

The DIA Customer Services Team will be pleased to assist you with your registration. 

Please call us on +41 61 225 51 51 from Monday to Friday between 08:00 and 17:00 CET. 

© DIA 2009

Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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