EuroMEEting - Genetic Alliance UK

EuroMEEting 

gEnEva 2011 

28-30 March 2011 

Palexpo 

Geneva, Switzerland 

23rd a nnual 

• Neutral, global forum for more than 3,000 professionals 

involved in the development of medicines from over 50 

countries 

• Speakers from the European Medicines Agency, the European 

Commission, the FDA and other regulatory agencies from 

European countries and other regions of the world 

• More than 200 exhibitors on one of the largest exhibition 

floors in Europe 

• Unparalleled multidisciplinary networking opportunities 

• Student and professional poster sessions 

• Active involvement of patient organisations 

• Pre-conference tutorials led by expert instructors 

• Hot topic sessions 

Advance 

Programme

2 

Table of Contents 

Programme Advisors 2 

EuroMeeting 2011 Co-Chairs' message 3 

EuroMeeting 2011 Theme Leaders 4 

Plan your EuroMeeting Experience 5 

Opening Plenary 6 

Special Sessions 7-8 

Student and Professional Posters 8 

DIA Fellowships 9 

Hot Topics and Stand Alone Sessions 42-43 

Exhibition 44 

About Geneva 45 

Networking Events 46 

Accommodation and Transport 47 

EuroMeeting at a Glance 50-52 

Key Contacts 53 

Registration Form 54 

Pre-Conference Tutorials 9-14 

Greening the EuroMeeting 15 

Sessions: Theme 1 - 15 16-42 

Programme Advisors 

Christer Backman, EU Coordinator Scientific and Regulatory Strategy, Medical 

Products Agency, Sweden 

Melek Bostanci Onol, DRA Manager, Boehringer Ingelheim Ilac Ticaret A.S., 

Turkey 

Laurie Burke, Director, Study Endpoints and Labeling, Office of New Drugs, 

CDER, FDA, USA 

Bengt Jönsson, Associate Professor, Stockholm School of Economics, Sweden 

Susanne Keitel, Director, EDQM (European Directorate for the Quality of 

Medicines and Healthcare), EU 

Armin Koch, Head of Institute of Biometry, Hannover Medical School, Germany 

Suzette Kox, Senior Director, Scientific Affairs, EGA, Belgium 

Stephane Callewaert, Senior Manager, Regulatory Policy, Worldwide Vaccine 

Registration, GlaxoSmithKline Biologicals, Belgium 

Daan Crommelin, Scientific Director, Top Institute Pharma, The Netherlands 

Fritz Erni, Consultant, Switzerland 

Amanda Maxwell, Manager, SFL Regulatory Affairs Consulting, UK 

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

Estelle Michael, Senior Manager, Regulatory Policy, GlaxoSmithKline 

Biologicals, Belgium 

Michael Drummond, Professor of Health Economics, University of York, UK 

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

Bruno Flamion, Chair Scientific Advice Working Party (SAWP), CHMP; 

Professor Clinical Pharmacology, University of Namur, Belgium 

Aiden Flynn, Director, Biomarkers and Analytics, GlaxoSmithKline, UK 

Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, 

Pfizer AB, Sweden 

David Haerry, EATG Representative, European AIDS Treatment Group, Belgium 

Katarina Halling, Senior Scientist, PRO Consulting, Sweden 

Marisa Papaluca-Amati, Head of Scientific Support and Projects, European 

Medicines Agency, EU 

Mira Pavlovic, Deputy Director, DEMESP, HAS Haute Autorité de Santé, France 

Munir Pirmohamed, NHS Chair of Pharmacogenetics, The University of 

Liverpool, UK 

Andrea Rappagliosi, Vice President European Government Affairs & Head of 

Brussels Office, GlaxoSmithKline, UK 

Ingela Wiklund, Senior Research Leader, United Biosource Corporation, UK 

John Wise, Executive Director, The Pistoia Alliance, UK 

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

Pharmaceutical Affairs and Medical Technology, Ministry of Health, 

Welfare and Sport, The Netherlands

EUROMEETING 2011 CO-CHAIRS’ MESSAGE 

3 

Dear Colleague, 

The landscape of drug development is changing. At the DIA’s 23rd Annual EuroMeeting in Geneva, taking place from 28-30 March 2011, we are introducing important 

new themes such as Global Drug Development in the Real World. These will highlight new perspectives on current systems and stimulate discussion on new ways of 

working and opportunities for new partnerships. Discovering new synergies will be an important focus and will be particularly appropriate in the truly international 

setting of Geneva. 

Innovation is always centre stage at the DIA – this EuroMeeting will ask whether we are really delivering the benefits of new science and technology. Are the products of 

pharmacogenomics coming on stream? Is patient safety improving as a result of pharmacogenetic knowledge and will the drug-device boundary disappear? Hand-inhand 

with this debate will be a discussion on better and early access to innovative treatments. Risk management throughout the product lifecycle is now embedded in 

practice both in industry and the regulatory world. Is it time to move on to benefit/risk management in practice and to align regulatory process and health technology 

assessment? 

By 2011, regulation will have reached another significant milestone with the package of measures on pharmacovigilance and counterfeit medicines. The challenges 

will be in implementing these new measures to achieve the aimed-for benefits in public health protection without compromising the better regulation principles of 

proportionality and targeting. 

Better risk communication remains perhaps the biggest challenge of all. No medicine or healthcare product is completely risk-free. Tools and methodologies for 

detecting and managing risk have advanced significantly but arguably industry and regulators have yet to benefit from the science of risk communication. Can we 

embrace the best practices from other fields and disciplines? 

With so many new topics to debate, you may ask what will you not see on the Geneva EuroMeeting 2011 scientific programme! At this meeting the patient perspective 

will no longer be addressed in a separate theme. This does not mean that the patient perspective is being ignored. On the contrary, it will be evident in every theme 

and throughout the whole meeting. We feel strongly that patients’ contributions should no longer be an add-on or an after-thought but integrated in every aspect. 

We wish to ensure that the DIA’s 23rd Annual EuroMeeting in Geneva will be a milestone in drug development science, regulatory evolution, stakeholder involvement 

and partnership working. Join us there, contribute your views and participate in debate – we will all benefit. 

June Raine and Valdo Arnera 

June Raine 

Director, Division of Vigilance Risk Management of Medicines, MHRA, UK 

Dr. June Raine trained in general medicine in Oxford after completing a Master's degree by research in Pharmacology. Her interest in drug 

safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development 

within the UK national authority. Appointed in 1999 to head Pharmacovigilance in the Medicines Control Agency (now Medicines and 

Healthcare products Regulatory Agency), she was elected in 2005 to chair the CHMP’s Pharmacovigilance Working Party. She is also 

a member of the WHO Advisory Committee on Safety of Medicinal Products. Her special interests are in monitoring the outcomes of 

regulatory action, risk communication and patient involvement in the regulatory process. 

Valdo Arnera 

General Manager, PHT Corporation, Switzerland 

A medical doctor by training, Dr. Valdo Arnera has over 25 years of experience in the pharmaceutical industry. After having practiced 

medicine in various positions, he started his career in the industry as a clinical pharmacologist in a Ciba-Geigy subsidiary. In 1992, he 

founded the first European Central Clinical Laboratory dedicated to clinical trials, SciCor (now Covance Central Laboratory). He joined PHT, 

an electronic diary technology provider in 2000, and founded its European affiliate in Geneva in January 2001. Skilled in both science and 

management, Dr. Arnera currently serves as the General Manager of PHT’s European operations. He has also been an active Co-chair of the 

DIA’s Special Interest Area Communities (SIAC) eClinical and Standards and previously served on the Advisory Council of Europe for several 

years. 

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 DIA. 

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.

4 

EUROMEETING 2011 THEME LEADERS 

Christelle Anquez-Traxler 

Regulatory and Scientific Affairs 

Manager, AESGP, Belgium 

Robert Hemmings 

Statistics Unit Manager, MHRA, UK 

Michael Pfleiderer 

Head of Section, Viral Vaccines, 

Paul-Erhlich-Institut (PEI), Germany 

Timothy Buxton 

Head of Sector, ICT Development, 

European Medicines Agency, EU 

Michael Hotze 

Director, Head of Clinical Research, 

Institut Straumann AG, Switzerland 

Ineke Rijnhout 

Consultant, Kenko International, 

The Netherlands 

Vincenzo Cannizzaro 

Regulatory Affairs Specialist, Spain 

Wills Hughes-Wilson 

Senior Director, Health Policy Europe, 

Genzyme, Belgium 

Jean-Louis Robert 

Head, Department of Medicines Control 

Laboratory, National Health Laboratory, 

Luxembourg 

Chris Chamberlain 

Medical Director, Personalised Medicines, 

AstraZeneca Pharmaceuticals LP, UK 

David Iberson-Hurst 

Vice President, Technical Strategy, 

CDISC, UK 

Tomas Salmonson 

Vice Chairman, CHMP, Director Scientific 

and Regulatory Strategies, MPA, Sweden 

Olivier Chassany 

Medical Head, Clinical Research & 

Development Department, Assistance 

Publique - Hôpitaux de Paris, France 

Angelika Joos 

Director, Regulatory Policy, Europe, 

Merck Sharp & Dohme (Europe) Inc., 

Belgium 

Urszula Scieszko-Fic 

Registration Director, Temapharm Sp. 

z.o.o., Poland 

Nancy Claude 

Director of Drug Safety, IRIS, France 

Jürgen Kübler 

Global Head, Statistical Safety Sciences, 

Novartis Pharma AG, Switzerland 

Philippa Smit-Marshall 

Vice President Medical and Scientific 

Affairs, PharmaNet B.V., The Netherlands 

Philippe Close 

Chief Safety Officer, Novartis Pharma 

AG, Switzerland 

Pierre-Yves Lastic 

Senior Director, Data Privacy & 

Healthcare Interoperability Standards, 

sanofi-aventis, France 

Per Spindler 

Director, Biopeople, University of 

Copenhagen, Denmark 

Bruno Flamion 

Chair Scientific Advice Working Party 

(SAWP), CHMP; Professor Clinical 

Pharmacology, University of Namur, 

Belgium 

Georges France 

Vice President, Quality Strategy, Global 

Quality Operation, Pfizer, UK 

Birka Lehmann 

Director and Professor, Head of Licensing 

Division 3, BfArM, Germany 

Andrew P. Marr 

Director, Global eRegulatory 

Development, Global Regulatory 

Operations, GlaxoSmithKline, UK 

Sabine Straus 

Head of Pharmacovigilance, Medicines 

Evaluation Board (MEB), The 

Netherlands 

Thomas Verstraeten 

Head Biologicals Clinical Safety & 

Pharmacovigilance, GlaxoSmithKline 

Biologicals, Belgium 

Shayesteh Fuerst-Ladani 

Director, SFL Regulatory Affairs and 

Scientific Communication, Switzerland 

Henrik Kim Nielsen 

Corporate Vice President, Novo Nordisk 

A/S, Denmark 

Christa Wirthumer-Hoche 

Deputy Head, AGES PharmMed, Austria 

About the DIA EuroMeeting 

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 as well as 

delegates from patient organisations. This convergence affords participants 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. The DIA is committed to the broad dissemination of information on the development of new medicines or 

generics, biosimilars, medical devices and combination products with continuously improved professional practice as the goal. The DIA is an independent non-profit 

organisation. 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. 

DIA Europe's 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.

PLAN YOUR EUROMEETING EXPERIENCE 

5 

► Knowledge ► Networking ► EuroMeeting Information 

Sunday, 27 March 2011 

15:00-18:00 Conference Registration/Information Open at Palexpo. 

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, 28 March 2011 

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

09:00-12:30 Pre-Conference Tutorials – See page 9-14 

09:00-10:30 Student Workshops 

11:00-12:30 Student Session – See page 7-8 

11:00-12:30 Young Professionals Session – See page 7 

Wednesday, 30 March 2011 


08:00-16:00 Exhibition Open 

08:00-09:00 Welcome Coffee 

09:00-10:30 Session 5 - Choose from 15 parallel sessions! 

10:30-11:00 Coffee Break 


11:00-12:30 Town Hall Meeting - See page 7-8 

12:30-14:00 Lunch 




CONFERENCE CLOSES 

CONFERENCE OPENS 

12:30-14:00 Lunch 


14:00-17:15 Opening Plenary Session – See page 6 

17:30-19:30 La Grande Reception: 

Networking Reception at the Ramada Park Hotel 

Tuesday, 29 March 2011 


08:00-09:00 Welcome Coffee 





12:45-13:45 Patients’ Working Lunch 

12:30-14:00 Lunch 

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

Meet and Eat 

13:30-14:00 Speed Networking 




16:00-17:30 Japanese Regulatory Session – See page 7 

Special Session 

GCP Forum 

Session 1605/1606 | Wednesday, 30 March 2010 | 09:00-12:30 

THE CHALLENGES FOR REGULATORS AND SPONSORS WHEN DEALING 

WITH CLINICAL TRIALS IN A GLOBAL SETTING 

Session Co-Chairs: 

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

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


FDA's International Collaborative Activities to Exchange Scientific, 

Regulatory and Ethical Information in the Conduct of Clinical Trials 

Cynthia Kleppinger, Medical Officer, Division of Scientific Investigations, Office 

of Compliance, CDER FDA, USA 

International Cooperation on GCP and Ethical rRquirements for Clinical Trials 

- Current EMA activities 

Fergus Sweeney, Head of Sector, Compliance and Inspection, European 


International Clinical Trials – Current Afssaps activities 

Pierre-Henri Bertoye, Inspectorate and Companies Associate Director, Afssaps, 

France 

Risk-Based Quality Management in Clinical Trials- A European Regulator’s 

View 


Industry / CRO delegates invited 

See page 43 for details. 

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

18:30-20:00 Joint Swissmedic and WHO Satellite Session – See page 7

6 OPENING PLENARY 

O P E N I N G P L E N A R Y 

GENEVA 2011 

Monday, 28 March 2011 | 14:00 - 17:15 

The 23rd Annual DIA EuroMeeting 2011 opens at a time of unprecedented 

change and challenge for the pharmaceutical industry, academia and regulators 

– in a climate of great expectations for groundbreaking scientific innovation, 

efficient cost-effective delivery, high standards of patient protection, excellent 

communication and transparency and best value for payers as well as patients 

and professionals. 

In the international city of Geneva it is right that we should be thinking beyond 

the boundaries of Europe. We should be building bridges, removing old 

boundaries: there is no doubt that the time has truly come for all stakeholders 

to work together in the best interests of public health. 

It is time for clearly defined goals, commonality of purpose and above all for visionary leadership. Where should our priorities be, and how can these 

enormous challenges become opportunities? 

It is therefore fitting that the EuroMeeting 2011 should begin with a Keynote Address from Commissioner John Dalli of DG SANCO. Commissioner Dalli will 

share his vision for optimising the health of the 500 million citizens of Europe and the part to be played by pharmaceuticals in achieving this. Following the 

move of the responsibility for pharmaceuticals from DG Enterprise to DG SANCO it is a unique opportunity to look ahead. This vision will be a framework 

for the themes and sessions of the Euromeeting to follow, and a context for the detailed discussions over the following days. 

In these exciting times, discussion must be challenging as well as reflective, stimulating and informative. So what better time than now to get down to 

reality, and listen to leaders in their fields debate. 

Come and join us in the plenary, participate in the debate and cast your vote! 

Keynote Address 

John Dalli 

European Commissioner responsible for Health 

and Consumer Policy 

John Dalli started to serve as a Cabinet Minister in the Maltese Government 

in 1987 having been first elected to the House of Representatives of Malta on 

behalf of the Nationalist Party in 1987. He served as Parliamentary Secretary 

for Industry (1987-1990), Minister of Economic Affairs (1990-92), Minister of 

Finance (1992-1996, 1998-2003), Minister of Finance and Economic Affairs and 

Minister of Foreign Affairs and Investment Promotion (2004). Between March 

2008 and February 2010, John Dalli served as Minister for Social Policy which 

includes the health, housing, employment and industrial relations portfolio. 

Oxford Debate 

There will also be an “Oxford Debate” following the University of Oxford’s 

eminent tradition. The working title for the debate is: "The current regulatory 

system does not support timely patient access to beneficial medicines". 

Moderator 


Debaters 

Andrew Dillon, Chief Executive, NICE, UK 

Peter Bonne Eriksen, Senior Vice President, Global Regulatory Affairs, 

Novo Nordisk, Denmark 

Greetje Goossens, Counseler, European Myeloma Platform, The Netherlands 

Jean Marimbert, Director-General, AFSSAPS, France 

As a qualified accountant, Dalli also worked in the private sector in Malta and 

abroad, both in industry and as an independent consultant. 

In February 2010 John Dalli was appointed European Commissioner responsible 

for Health and Consumer Policy.

SPECIAL SESSIONS 

7 

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

Student Sessions 

Session 1701 | Monday, 28 March 2011 | 09:00-09:40 

PRESENT WITH CONFIDENCE WORKSHOP 

Instructor: Judy Churchill, Communication Skills Specialist, France 


CURRICULUM VITAE WORKSHOP 

Instructor: To be confirmed 

Students attending this workshop will receive tips and advice on creating a 

winning CV. 


DIA STUDENT CHAPTER SESSION 

2015 Roadmap Session 

Session 1603 | Tuesday, 29 March 2011 | 14:00-15:30 

Session Chair: 

Noel Wathion, Head of Public Health Protection, European Medicines Agency, 

EU 

On 26 January 2010, the European Medicines Agency published a draft paper 

setting out its vision for the strategic development of the Agency for the five 

years to 2015. Building on the progress of its previous five-year strategy, the Road 

Map to 2015 charts the way forward for the Agency amid rapid developments 

in medical science and pharmaceutical research, as well as the continuing 

evolution of the European and international regulatory environments. With this 

strategy paper to guide it, the Agency will seek to consolidate its achievements 

to date and further strengthen its role as a guardian of human and animal health 

in the European Union. 

Emer Cooke, International Liaison Officer, European Medicines Agency, EU 

in partnership with the European Pharmaceutical Students’ 

Association (EPSA) and the International Federation of 

Medical Students’ Associations (IFMSA). 

All student participants are invited to join an informal networking and 

information session in which they can learn more about a range of professional 

disciplines in the pharmaceutical world: What do they involve? What is the best 

way in? What are the challenges and the opportunities? 

Taking the innovative form of an interactive attendee-led “unconference”, which 

does not have any agenda, speakers or presentations, participants begin by 

discussing what they would like to get out of the session and what topics of 

interest they would like to see covered. A group of experienced professionals 

from a range of pharmaceutical backgrounds will lead small groups of students 

in discussion around the room. There will be an open format and students may 

move from one group to another. 

Young Professionals Session 



Estelle Michael, Senior Manager Regulatory Policy and Intelligence, 

GlaxoSmithKline, Biologicals, Belgium 

Currently under development. 

Heads of Medicines Agencies Session 



Kent Woods, Chief Executive, MHRA, UK 

Jean Marimbert, General Director, Afssaps, France 

Jytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark 

Session under development 

Town Hall Meeting 

Session 0206 | Wednesday, 30 March 2011 | 11:00-12:30 

MEET THE REGULATORS 

Moderator: 

Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria 

The Town Hall Meeting is an open interactive session where participants can 

ask key decision makers in the European Regulatory system burning questions. 

The panel will include representatives from the European Medicines Agency, 

National Competent Authorities and a patient organisation. 

The topics/questions discussed are decided by the attendees and should be 

related to: 

• Responsibility of the Agencies in the EU network 

• Authorisation and Maintenance of Medicinal Products; Benefit/Risk 

Methodologies 

• Pharmacovigilance 

• International Cooperation and Inspection-Related Issues 

• Electronic Submission 

• The Role of Patient Organisations 

Responsibilities of the Agencies in the EU Network 


EU 

Aginus Kalis, Chair HMA-MG, Executive Director, Medicines Evaluation Board 

(MEB), The Netherlands 

Authorisation and Maintenance of Medicinal Products; Benefit/Risk 

Methodologies 


Eric Abadie, Chair CHMP, Chair Pharmacogenomics Working Party, General 

Director, Afssaps, France 

Truus Janse-de Hoog , Chair CMD(h), Staff member MEB, European cluster, 

Medicines Evaluation Board, The Netherlands 

Aginus Kalis, Executive Director, Medicines Evaluation Board (MEB), The 

Netherlands 

Marcus Muellner, Director, AGES PharmMed, Austria

8 

SPECIAL SESSIONS | STUDENT AND PROFESSIONAL POSTERS 


Pharmacovigilance 

June Raine, Director, Chair PhVWP, Director, Division of Vigilance Risk 

Management of Medicines, MHRA, UK 

Peter Arlett, Head of Pharmacovigilance and Risk Management, European 


International Cooperation and Inspection-Related Issues 


Electronic Submission 

Timothy Buxton, Head of Sector, ICT Development, European Medicines 

Agency, EU 

Abstract Guidelines: 

• All professional poster abstracts must be received by Friday, 14 January 2011. 

Submit your abstract online by going to www.diahome.org and clicking on 

the EuroMeeting icon 

• Abstracts are limited to 100 words 

• Abstracts may not refer to specific brand names 

• Abstracts should follow a structured format including objectives, methods, 

results, and conclusions 

• Submissions must include complete contact information 

If you require further information on Student or Professional Posters please 

contact Maureen McGahan at DIA Europe: maureen.mcgahan@diaeurope.org 

The Role of Patient Organisations 

Albert Van der Zeijden, Board Member, International Alliance of Patients 

Organisations, UK 

Joint Swissmedic and 

WHO Satellite Session 


CO-OPERATION BETWEEN SWISSMEDIC AND WHO 


To be confirmed 

Establishing and maintaining a well-functioning network between international 

armonization like the WHO and Regulatory Authorities is key to address public 

health issues in a globalised world. It also elaborates on the potential impact 

of cooperation between WHO and regulators to the industry. This Satellite 

Symposium looks at how WHO works with Regulators in general and in 

particular with the Swiss Agency for Therapeutic Products, Swissmedic. We 

will look at how the cooperation works, what challenges had to be addressed 

and what the outcome finally was by presenting two practical examples taken 

from the field of pharmacovigilance and counterfeit drugs. 

Introduction: How the WHO works with regulators 

Speaker to be confirmed 

Overview of Cooperation between Swissmedic and the WHO 


Real-time Pharmacovigilance: The development of Paniflow 


Counterfeit Drugs: The way forward 


Call for Professional Poster Abstracts 

Deadline: 14 January 2011 

A maximum of 40 abstracts from full-time professionals will be selected for 

the professional poster presentation to be held on Wednesday, 30 March 2011. 

Selected professional poster presenters will be required to pay the applicable 

meeting registration fee and will be responsible for all other meeting expenses. 

One professional poster will be selected at the EuroMeeting 2011 Geneva as the 

winner of the EuroMeeting 2011 Professional Poster Award. 

Call for Student Poster Abstracts 

Deadline: 1 December 2010 

Full-time university students, residents and fellows are invited to submit 

abstracts for the Student Poster Session which will take place on Tuesday, 29 

March 2011 at the EuroMeeting in Geneva. 

Prizes will be awarded to student winners based on the following criteria: 

• Bona fide research project 

• Specific objectives and hypothesis 

• Clear methods 

• Analysis of actual data and results 

• Conclusion 

A maximum of 20 abstracts will be selected for the student poster presentation. 

Eligibility: 

Full-time students, residents or fellows at the time of the EuroMeeting 2011. 

One author must attend the EuroMeeting. Past DIA EuroMeeting or Annual US 

meeting Student Poster Presenters will not be eligible. 

Benefits for Accepted Abstracts: 

• One fully supported registration for the EuroMeeting to include: return 

flight to Geneva, three nights' hotel accommodation and complimentary 

registration for the EuroMeeting 

• Abstracts will be published in an early 2011 issue of the Drug Information 

Journal 

• Prizes for three winning posters 

Abstract Guidelines: 

• All poster abstracts must be received by Wednesday, 1 December 2010. 

Submit your abstract online by going to www.diahome.org and clicking on 

the EuroMeeting icon. 

• Abstracts are limited to 100 words 

• A student may submit only one abstract 

• Abstracts may not refer to specific brand names 

• Abstracts should follow a structured format including objectives, methods, 

results and conclusions 

• Submissions must include complete contact information 

• Abstracts will be reviewed and authors notified of results by Wednesday, 15 

December 2010 

If you require further information on Student or Professional Posters please 

contact Maureen McGahan at DIA Europe: maureen.mcgahan@diaeurope.org 

To submit a poster, please visit 

www.diaeurope.org/euromeeting2011

DIA FELLOWSHIPS 

9 


DIA Patient Fellowship 

Application Deadline: 22 November 2010 

The DIA Patient Fellowship, now in its sixth successful year, is a programme to promote the participation of patient organisation representatives at the EuroMeeting. 

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

complimentary registration only to the EuroMeeting. 

• Complimentary admission to conference and pre-conference tutorial of choice 

• Specific DIA Patient Fellowship Booth to act as a focus point to network and to distribute information 

• Travel costs and up to 3 nights' hotel accommodation covered for 22 representatives 

• Patient Fellowship Reception on Sunday evening and daily briefings to encourage information and skills sharing 

DIA Young Professional Fellowship 

Application Deadline: 28 January 2011 

DIA Europe welcomes the involvement of young professionals in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 young 

professionals in full-time employment under the age of 30 at the time of the EuroMeeting 2011. 

DIA Student Fellowship 

Application Deadline: 28 January 2011 

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

education at the time of the EuroMeeting 2011. 

To apply for a Fellowship, please visit www.diaeurope.org/euromeeting2011 

Maureen McGahan is the Special Programmes Coordinator in the EuroMeeting team: Email: maureen.mcgahan@diaeurope.org or telephone +41 61 225 51 60. 

Pre-Conference Tutorials | Monday, 28 March 2011 | 09:00 - 12:30 

Tutorial 01 - Roundtable Discussion 

GCP INSPECTION AND AUDIT FINDINGS 

(Special €150 + VAT rate) 

Beat Widler, Global Head of Clinical Quality Assurance, 

F. Hoffmann-La Roche Ltd., Switzerland 

Fergus Sweeney, Head of Sector, Inspections, 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 prior to the EuroMeeting. 

Discussion Objectives 

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

discussion of key GCP issues arising from inspection and from 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 

Tutorial 02 

THE ‘NEW’ VARIATION REGULATION IN PRACTICE – ADVANTAGES 

AND PITFALLS 

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

Member of the CMD(h), BfArM, Germany 

The ‘new’ EU variation regulation (Commission Regulation (EC) 1234/2008) 

applicable since 1 January 2010 is aimed on one hand to simplify the submission of 

variations and on the other hand to give more strategic options to the applicant. 

Has this goal already been achieved? As usual, the practical implication of 

legislation has raised on both sides – the industry and the competent agencies. 

a number of questions. After one year of practical experience with the variation 

regulation a first resumé concerning the real advantages and so far identified 

pitfalls has been given. This takes into account the provided Best Practice 

Guides and Q&A documents and the practical experience gained thus far. 

The aim of this tutorial is to identify challenges and how they are solved by 

common and agreed solutions and interpretations. The area covered will 

concentrate on the new elements of the variation legislation (e.g. grouping) 

including annual report, work sharing and experiences with classification of 

change (Article 5, upgrading during validation), implementation, etc.

10 

TUTORIALS 



Learning Objectives 

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

• Identify the crucial definitions and interpretations of the Variation Guidelines 

and Best Practice Guides and to recognise their practical relevance 

• Identify advantages and avoid pitfalls in the regulatory framework 

• Identify safe resources with strategic decisions 


Regulatory affairs professionals from industry involved in the compilation, 

organisation and management of variations in the decentralised (MRP/DCP) or 

centralised procedure. 

Tutorial 03 

ORPHAN DRUGS IN THE EU: FROM DESIGNATION TO MARKETING 

AUTHORISATION 

Katrin Rupalla, Associate Director, Regulatory Affairs Europe, Celgene 

International SARL, Switzerland 

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


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

and what are the latest updates. In addition, the 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. This will in general be 

professionals from Drug Regulatory Affairs, Clinical Science and Public Affairs. 

Tutorial 04 

DEVELOPMENT OF PAEDIATRIC MEDICINAL PRODUCTS FROM A 

REGULATORY POINT OF VIEW 

Thomas Dobmeyer, Managing Director, YES Pharmaceutical Development 

Services GmbH, Germany 

Following an introduction to the medical, legal and regulatory background 

of the development of medicinal products for paediatric use, representative 

case studies of paediatric investigation plans will be presented. Participants 

will then learn to apply their knowledge. In small groups they will prepare an 

outline of the clinical part of a fictitious PIP for a medicinal product with a well 

known active substance which should be further developed for use in paediatric 

patients. 



• Define the legal and regulatory requirements for the development of 

medicinal products for paediatric use in the EU 

• Explain the content of Paediatric Investigation Plans (PIPs) as well as the 

processes required to prepare, submit and implement PIPs 

• Apply knowledge to briefly outline the clinical part of a PIP for a well known 

active substance 


• This tutorial is designed for people working in regulatory affairs who wish to 

have a more in-depth understanding of paediatric medicinal products. 

Tutorial 05 

AFTER THE PIP DECISION: MODIFICATION OF THE AGREED PIP, 

VALIDATION AND COMPLIANCE CHECK 

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

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

Agency’s 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 or not 

• 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 06 

SUCCESSFUL OUTSOURCING OF NON‐CLINICAL DEVELOPMENT 

PROGRAMMES – EXPERIENCES, RECOMMENDATIONS, VALUABLE 

TIPS 

Rüdiger Häcker, Global Business Development, Medicons GmbH, Switzerland 

Kai Blumbach, Manager, Safety Assessment Toxicology, Harlan Laboratories 

Ltd., Switzerland 

This tutorial will summarise the experiences of a contract research organisation 

which offers services for the conduct of non-clinical development programmes 

and the corresponding experiences from the view of a consultant which is 

managing the outsourcing for companies. It will illustrate how to manage the 

inherent key conflict of interest: The client is interested in getting better service 

in less time at lower costs whereas the CRO is interested in generating revenues 

- at a sufficiently high level of quality and satisfaction for the clients and the 

regulatory authorities.

TUTORIALS 

11 





• Design an appropriate non-clinical development strategy in partnership with 

a CRO and to establish a consolidated project 

• Manage and solve unexpected technical problems and study results in 

cooperation with a CRO 

• Perform fair negotiations about offers and contracts 


• Colleagues responsible for drug discovery programs and non-clinical 

development of drugs especially from start-up companies or small/midsize 

enterprises; also, colleagues from larger companies which are outsourcing 

non-clinical studies on a regular basis especially in the later stages of a 

successful drug development. 

Tutorial 07 

INTRODUCTION TO MEDICAL DEVICE REGULATION 

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

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


Erik Vollebregt, Attorney, Greenberg Traurig, 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 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 in the system and it will give 

insight in the legal requirements for clinical evaluation and clinical investigation. 

Furthermore the tutorial will provide insight in the EU regulation of in vitro 

diagnostics (IVDs). 



• Understand the definition of a medical device 

• 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) 

• Understand the system of conformity assessment by Notified Bodies 

• Understand the principles of risk classification 

• Understand the legal requirements for clinical evaluation and clinical 

investigation 

• Understand the main characteristics of the EU In Vitro Diagnostic Directive 


• 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 

• EuroMeeting participants who plan to attend the theme “The Drug/Device 

Boundary: Is it about to Disappear? 

Tutorial 08 

DATA PRIVACY IN CLINICAL TRIALS AND PHARMACOVIGILANCE 

Pierre-Yves Lastic, Senior Director, Data Privacy and 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 of 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 09 

HOW TO PREPARE FOR THE IMPLEMENTATION OF THE NEW ISO/ 

ICH INDIVIDUAL CASE SAFETY REPORT (ICSR) STANDARD IN THE 

FRAME OF THE ICH GUIDELINE E2B (R3) 

Anja van Haren, EudraVigilance Coordinator, Medicines Evaluation Board, 


Gaby Danan, Expert in Pharmacovigilance, Senior Director, Global 

Pharmacovigilance and Epidemiology, sanofi-aventis, France 

The international standardisation for the new Individual Case Safety Report 

(ICSR) is rapidly progressing. This standard will provide the format for the 

electronic transmission of ICSRs by marketing authorisation holders to the 

European Medicines Agency in accordance with the new provisions resulting 

from the amendment of Regulation 726/2004 and Directive 2001/83/EC, which 

was initiated by the European Commission in December 2008 with the goal of 

strengthening and rationalising the European Community pharmacovigilance 

system for medicinal products for human use. 

This tutorial will provide participants with the opportunity to familiarise 

themselves the concepts defined in the ISO ICSR standard, to learn how the ISO 

message exchange standards will be applied and to obtain an understanding on 

how the standards will be implemented at ICH level in the frame of the guideline 

E2B (R3).

12 

TUTORIALS 





• Recognise the new ISO/ICH ICSR content and message 

• Compare the current E2B R2 ICSR with the new standard ISO/ICH E2B (R3) 

• Interpret correctly the new requirements and data elements of the new ISO/ 

ICH E2B(R3) ICSR 


Qualified Persons responsible for Pharmacovigilance (QPPVs) and individuals 

involved in: 


• Clinical Data Management 

• Clinical Development 

• Information Management 

• Safety Databases 

Tutorial 10 

HOW TO PREPARE FOR THE IMPLEMENTATION OF THE ISO/ 

HL7/ICH IDENTIFICATION OF MEDICINAL PRODUCT (IDMP) 

STANDARDS 

Sabine Brosch, Business Lead EudraVigilance and International Standardisation 

in Pharmacovigilance and Risk Management Sector, European Medicines 

Agency, EU 

Vada Perkins, Regulatory Program Management Officer, FDA, USA 

The international standardisation in the area of the new Identification of 

Medicinal Products (IDMP) is rapidly progressing. This standard will provide 

the format for the electronic submission of medicinal product information 

by marketing authorisation holders to the European Medicines Agency in 

accordance with the new EU pharmacovigilance legislation. 

The ISO IDMP Draft International Standards were released on 23 September 

2010 for a five-month ballot and the ICH has initiated testing. 

This tutorial will provide participants with the opportunity to familiarise 

themselves with the concepts defined in the five ISO IDMP standards, to learn 

how the HL7 message exchange standards will be applied and to obtain an 

understanding on how the standards will be implemented in the EU and the US. 

The technical and business process related aspects that need to be taken into 

account in preparing for a coordinated, well-organised approach in putting the 

new standards in operation will be also addressed. This also includes the use of 

the IDMP standards in the context of the new ISO Individual Case Safety Reports 

(ICSR) standard. 



• Update on the ongoing international IDMP standardisation work 

• Recognise the main new features of the five IDMP standards 

• Recognise the interface of the IDMP and ICSR standards with the new 

pharmacovigilance legislation in the EU 

• Prepare for the implementation of the new IDMP standards in the EU and the 

US focusing on potential adaptations to regulatory product management and 

pharmacovigilance systems 


• Representatives of IT departments of medicines regulatory authorities, 

pharmaceutical companies and service providers 

• Regulatory affairs staff of pharmaceutical companies 

• EU Qualified Persons responsible for Pharmacovigilance (EU QPPVs) 

• Pharmacovigilance staff of pharmaceutical companies and medicines 

regulatory authorities 

• Medicinal product management software vendors 

• Sponsors of clinical trials 

Tutorial 11 

TAILORING SERVICE AGREEMENTS IN PRE-CLINICAL R&D TO 

YOUR NEEDS 

Claudia Luetzeler, Attorney, Luetzeler und Partner Rechtsanwaelte, Germany 

Pre-clinical research and development often rely on external service providers 

for the provision of various activities (e.g. performance of toxicity studies, 

development of companion diagnostics). Any non-legal personnel involved in the 

negotiation of service agreements with the respective service providers needs 

a basic understanding of the relevant contractual issues such as identification 

of regulatory requirements, allocation of arising intellectual property, and scope 

of warranties and limitation of liability. It is the aim of the tutorial to discuss 

different and potentially conflicting interests of the parties, mechanisms for 

their resolution and examples for contractual clauses, also including general 

aspects that need to be covered in service agreements. 



• Identify critical legal issues in agreements with service providers in the field 

of pre-clinical R&D 

• Interpret and evaluate typical contractual clauses 

• Propose and negotiate practical solutions for conflicting interests of the 

parties 


• Any non-legal personnel involved in the negotiation of service agreements 

with service providers in the field of pre-clinical R&D 

Tutorial 12 

UKRAINE, BELARUS, KAZAKHSTAN: FURTHER HARMONISATION 

OF CLINICAL TRIALS REGULATION - HOW TO BENEFIT? 

Andrei Kravchenko, Head of Representative Ukraine Office, Harrison Clinical 

Research, GmbH, Germany 

Ukraine, Belarus and Kazakhstan are countries with different clinical trials 

markets and environments. Originating from common system of the Soviet 

Union, each of these countries had their own development including reformation 

of healthcare systems and set up of local legislations for clinical trials. This 

tutorial has been designed to describe current status of clinical trials market 

in each country and demonstrate ways of usage advantages in each of them in 

the most efficient way. 



• Describe the status of clinical trial legislation and its impact on the clinical 

trials environment in Ukraine, Belarus and Kazakhstan 

• List the benefits and how to avoid the typical mistakes made, when running

TUTORIALS 

13 



clinical trials in Ukraine, Belarus and Kazakhstan. 

• Demonstrate key factors of success in Ukraine, Belarus and Kazakhstan 

• Distinguish between clinical trials environments in selected CIS countries 

• Recognise the strengths of each country and plan operations in or expansion 

to Ukraine, Belarus and Kazakhstan using presented experience 

• Apply knowledge of key success factors of current or planned clinical trials in 

Ukraine, Belarus and Kazakhstan 


• Clinical Operation Managers 

• Project Managers 

• Directors of Strategic Development 

• Managing Directors of CROs and pharma companies planning or expanding 

operations to Ukraine, Belarus and Kazakhstan 

• Other clinical research professionals investigating clinical trials environments 

in CIS countries 

Tutorial 13 

QUALITY RISK MANAGEMENT (QRM): A PRACTICAL GUIDE TO 

BRINGING A DATA-DRIVEN DECISION METHODOLOGY IN GCP QA 

AND PHARMACOVIGILANCE ACTIVITIES 

Mike Britt, Global Head Systems Validation, Roche Products Ltd, UK 

Volker Rönicke, Principal, Booz & Company, Germany 

Quality Risk Management (QRM) is an innovative solution that extends the 

use of common risk management methodologies and couples with existing 

company data sources to deliver a true risk-based approach to GCP QA and 

pharmacovigilance, with potential for a 100% scope of coverage and oversight. 

QRM applies prospective management of potential quality, compliance, 

performance issues before issue manifestation by providing the right quality/ 

compliance fact base to make crucial resource deployment decisions as well as 

planning and implementing focused mitigating actions. 



• State the basic principles of QRM with a view to translating them back into 

operational practice within their own companies 

• Recognise and interpret the benefits of QRM within their own companies 

(and potentially beyond) 

• Propose the formulation and computation of quality metrics (Key Risk 

Indicators) within a QRM model which will differentiate between different 

entities with regards to Quality 

• Identify the steps and the approach that must be taken to implement QRM 

in their organisations 


• GCP and PV Auditors 

• CQA Managers 

• GCP and PV Compliance Managers 

• GCP and PV Trainers 

• Study Managers 

• Monitors/CRAs 

Tutorial 14 

NON-CLINICAL SAFETY ASSESSMENT OF PHARMACEUTICALS 

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

Germany 

This tutorial has been prepared to provide participants with an overview of 

the importance of toxicology studies and where they fit in the pharmaceutical 

development. Participants will be offered the opportunity to discuss the 

relevant ICH guidelines concerning toxicological disciplines. In addition the 

problem of impurities in pharmaceuticals and the regulatory requirement will be 

discussed. Good understanding of the implications of non-clinical data is crucial 

when designing or preparing a submission dossier including the non-clinical 

section in the Summary of Product Characterisation (SmPC) for the competent 

authorities. 


At the conclusion of this tutorial participants will be able to: 

• Understand the basic principles of non-clinical safety assessment 

• Recognise the importance of non-clinical studies in the phases of drug 

development 

• Describe the requirements for safety by agencies 

• Understand the non-clinical section in the SmPC 


• Non‐toxicologists or beginners in toxicology 

• Regulatory affairs personnel, clinical research 

• Project team leaders 

• Regulators with interest in non-clinical safety assessment 

Tutorial 15 

RISK SHARING AND PATIENT ACCESS SCHEMES – THEIR VALUE 

IN REDUCING UNCERTAINTY OF THE REAL WORLD BENEFITS OF 

MEDICINES 

François Lucas, Principal Consultant, Pope Woodhead and Associates, UK 

Risk-sharing schemes aim to allow access to innovative drugs while reducing 

financial burden and uncertainty for the healthcare system. Such schemes 

emerged in response to negative HTA evaluations of expensive drugs with an 

uncertain clinical and economic evidence basis at launch. In some schemes, 

payment of the drug is based on its real-world performance; others are 

financed-based, setting caps on payments or offering free initial treatment. A 

further dimension is whether the scheme is associated with an observational 

study or operates at the patient level. This tutorial has an interactive, ‘hands 

on’ format, and is focused on: understanding the ‘theory’ and range of possible 

‘risk sharing’ schemes, evaluating scheme options, managing stakeholder 

relationships, and implementing feasible and cost-effective schemes. 



• Describe the theory behind risk sharing and the link to HTA and payer 

evaluation 

• Decide when such an approach is valuable to the healthcare system and 

patients 

• Consider the practical challenges in implementing the schemes

14 

TUTORIALS 




• Hospital pharmacists 

• Physicians, in particular oncologists, where this approach is common 

• Pharmaceutical company executives with responsibility for pricing, 

reimbursement and market access 

Tutorial 16 

INTRODUCTION TO CRISIS MANAGEMENT 

Jan-Willem van der Velden, CEO, Founding Director, Mesama Consulting, 

Switzerland 

Michael Forstner, Integrated Safety Risk Manager, F. Hoffmann-La Roche Ltd., 

Switzerland 

In this introductory tutorial the participant will be made familiar with the 

definition of a crisis and understand which processes in their own working 

environment could be vulnerable for possible crises. Examples are given and 

participants are invited to join in exercises and learn which parties are all 

involved within and outside their organisation. The participant will be provided 

with the tools with which to plan for a potential crisis and how to build a 

preventive strategy. The roles of the Crisis Management Team members are 

shown and examples are given of right and wrong actions, including attitude 

towards the media. 



• Distinguish between an issue, a risk and a crisis and recognize the flow of 

events that lead from an issue to a crisis 

• Recognise a potential crisis on time and approach a crisis appropriately when 

it happens 

• Set up a crisis team that should be able to deal with the crisis in all its stages 


• Regulatory authorities 

• PV experts 

• Pharmaceutical industry 

• Medical affairs 

• Drug safety department 

• Marketing department 

• Legal department 

• Corporate communications department 

Tutorial 17 

INCENTIVES TO DRUG DEVELOPMENT: EXPAND YOUR 

REGULATORY INTUITION 

Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU 

Christelle Bouygues, Regulatory Affairs Advisor, European Medicines Agency, 

EU 

This tutorial will present, in the light of an ever-changing EU legislative 

environment, the recent incentives to drug development which are of scientific, 

financial and regulatory procedural nature or a combination of those. The 

tutorial will cover in detail the various data exclusivity provisions, the orphans, 

paediatrics and ATMPs incentives as well as provide an insight into the 

experience with the operation of “early access tools” such as the accelerated 

review, the conditional and exceptional circumstances MAs by EMA/CHMP. 

Each aspect will be applied in practice through interactive case studies. 



Having a detailed knowledge and early consideration of these incentives and 

tools should enable the participants to expand their regulatory intuition; as a 

result: 

• Anticipate, plan and streamline the milestones for their drug development 

and registrations 

• Develop a sound regulatory strategy optimizing the use of the various 

incentives and tools provided for. 

• Discuss advantages and disadvantages of different regulatory strategies for 

their business pipeline with concerned regulatory authorities 


• All persons involved in business intelligence, regulatory affairs, business 

pipeline and regulatory authorities. 

Continuing Education 

DIA Europe has applied for credits from the Faculty of Pharmaceutical Medicine (FPM) of 

the Royal College of Physicians (RCP) of the UK. 

DIA Europe's meetings are accredited by the SwAPP (Swiss Association of Pharmaceutical 

Professionals) Commission for Professional Development and SGPM (Swiss Society of 

Pharmaceutical Medicine). 

Always Stay One Move AheadWith DIA Training Courses 

The Best Value Training Available Anywhere. 

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 safety sciences and pharmacovigilance. Benefits 

include: 

• Expert instructors actively practicing in their particular discipline 

• Continuing education credits 

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

• Networking opportunities 

• Consistent course materials from one offering to another 

• 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 Training.

GREENING THE EUROMEETING 

15 

GREENING THE EUROMEETING 

TOWARDS AN ENVIRONMENTALLY FRIENDLY CONFERENCE 

Geneva is a city which takes its responsibility for the environment seriously, from 

renewable energy production to its efficient public transport system. This commitment 

to the environment extends to the Palexpo Convention Centre who share the DIA’s 

commitment to an environmentally-friendly EuroMeeting. Waste recycling for some 

events at Palexpo has now reached levels of nearly 80%. Other measures include the 

provision of all of Palexpo’s energy needs by hydro-electric power and/or solar panels 

on the roof of one of the halls and an electrical charge port for two-wheel vehicles in the 

parking area which may be used free of charge. 

Using practical, innovative, and often very simple measures, the EuroMeeting’s carbon 

footprint has been successfully reduced. We will be practicing the 3Rs in Geneva: Reduce, 

Recycle and Reuse. 

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 will be placed throughout the building. 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 exhibitors is an important part of the EuroMeeting, and we look forward to a successful partnership in 2011. The Greenest Exhibitor Award, 

now in its third year, aims to raise the awareness of exhibitors of this growing movement in the conference and exhibitions industry. We make it easy 

for exhibitors to recycle. Additionally, we ensure that stand carpets, for example, are recycled for use in other products such as pots and containers, and 

untreated wood is compacted, to be reused as medium-density fibreboard panels used by furniture manufacturers. 

The European office members will travel to the 2011 EuroMeeting by train. DIA will offset the air miles of other staff travelling to the EuroMeeting 

with a Swiss non-profit foundation, "myclimate" – The Climate Protection Partnership (www.myclimate.org), and we encourage all our participants and 

exhibitors to support our greening initiative by considering offsetting their miles. All participants will receive a free Geneva public transport card when 

checking in at their hotels. This promotion of public transportation helps to reduce congestion as well as pollution. 

We commit to not using disposable 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 able to eat healthily as low down the food chain as possible, with vegetarian 

options 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.

16 

THEME 1 


Theme 1 | Innovation, Future of Treatment and 

Personalised Medicine 

Chris Chamberlain, Medical Director, Personalised Medicines, AstraZeneca 

Pharmaceuticals LP, UK 



This theme will reflect on the operational and clinical problems that must 

be solved to make personalised healthcare a reality for patients. The goal 

is to signpost the route from the discovery to the clinical utility of novel 

biomarkers for the enlightenment of all stakeholders in the drug development 

process. Personalised Medicine represents the systematic attempt better 

to characterise patients though the application of emerging diagnostic 

technologies. It is a profoundly patient-centred discipline that applies 

experimental medicine and biomarker-based analyses to provide new 

diagnostics and helps deliver meaningful care improvements in real-world 

practice. The sessions will focus on the challenges of delivering and handling 

complex data sets in terms of operation and analytical parameters and will 

look at the emergence of new diagnostic platforms that can provide insights 

into disease pathology and help define drug response. 


09:00-10:30 Session 0101/0701 

TRIAL DESIGN AND INTERPRETATION FOR PERSONALISED HEALTHCARE – 

DELIVERING C21 DRUG DEVELOPMENT (JOINT WITH THEME 7) 



The emergence of new complex diagnostic technologies challenges traditional 

ways of interpreting the output from clinical trials. Successful Personalised 

Medicine relies on our being able to understand exactly what biomarker data 

is telling us and apply this to clinical development decisions. 

Statistic Approaches to Data Analysis for PHC- What does the data tell us? 

FDA speaker invited 

High Dimensional Data – What do we mean? 

Bryn Williams-Jones, Associate Research Fellow, Head of e-Biology, Pfizer 

Global Research & Development, UK 

Bio Informatic Tools for Complex Data 

Tom Freeman, Group Leader, The Roslin Institute, R(D)SVS, Division of Genetics 

and Genomics , University of Edinburgh, UK 

11:00-12:30 Session 0102 

THE ROLE OF PERSONALISED MEDICINE IN SAFETY 


Ann Daly, Professor of Pharmacogenetics, Institute of Cellular Medicine, 

Newcastle University, UK 

Personalised Medicine implies better informed prescription through a fuller 

understanding of risk benefit relationship at the individual level. This calls for a 

systematic appreciation of the predictability of adverse responses to therapy. 

Significant progress with the operational issues around collating safety signals 

for investigation is currently being made through large scale collaborative 

approaches. 

Assuring Safety: The role of the non-efficacy biomarkers in PHC 

Ann Daly, Professor of Pharmacogenetics, Institute of Cellular Medicine, 

Newcastle University, UK 

Innovation through Consortia: IMI Project PROTECT 

Elizabeth Swain, Director, Pharmacovigilance Advocacy and Policy, 

GlaxoSmithKline, UK 

SAFE T: A Collaborative Venture towards New Safety BMs 

Ina Schuppe Koistinen, Scientific Coordinator of SAFE-T, AstraZeneca, Sweden 

14:00-15:30 Session 0103 

DEVELOPING PERSONALISED MEDICINES – DELIVERING THE DIAGNOSTICS 


Nigel Spurr, PHC Portfolio Expert, Roche Products, UK 

The emergence of Personalised Medicine requires new insights into the covalidation 

of diagnostic and pharmacological products. Planning the codevelopment 

of diagnostic products is a growing part of clinical development 

and requires the entry of new skill sets into development processes. 

A Roadmap for PHC: Looking to where drugs and diagnostics meet 

Nigel Spurr, PHC Portfolio Expert, Roche Products, UK 

Why is the New Procedure for Qualification of Novel Methodologies for 

Drug Development at the European Medicines Agency Important for the 

Development of Personalised Medicine? 

EMA speaker invited 

Managing the PHC Lifecycles – The IRESSA experience 

Rose McCormack, Clinical Research Scientist, AstraZeneca, UK 

16:00-17:30 Session 0104/1104 

IN VITRO DIAGNOSTIC (JOINT WITH THEME 11) 


Mark Hope, Head of Program Management, F. Hoffmann-La Roche AG, 

Switzerland 

Case Study: Development of an IVD 

Stephen Little, Vice President, Personalised Healthcare, Qiagen, UK 

Point of Care Testing in Clinical Trials 

Michael Wickham, Managing Director, Woodley Equipment Company Ltd., UK 

Case Study of Regulatory Process of Registration of In Vitro Diagnostic with 

a Medicinal Product 


Switzerland 


09:00-10:30 Session 0105 

HOW TO PAY FOR PERSONALISED MEDICINE? THE VALUE OF 

STRATIFICATION 


Adrian Towse, Director, Office of Health Economics, UK 

Ultimately the sustainable delivery of medical innovation is dependent on 

the provision of sufficient incentives to warrant the considerable operational 

requirements of medical research and development. The successful prosecution 

of Personalised Medicine will be reliant on the provision of sufficient value to 

merit the underlying investment of time and effort required.

THEME 1 | THEME 2 

17 


Improving Drug Development – Stratification and Drug Rescue 

Adrian Towse, Director, Office of Health Economics, UK 

Drug Diagnostic Combinations – Incentives for Stratification 

Speaker invited 

Aligning Drug Diagnostic Development – Impact on Value 


11:00-12:30 Session 0106 

QUALIFY, VALIDATE, APPLY – ASSURING ASSAY QUALITY THROUGH THE 

BIOMARKER LIFECYCLE 


Glen Hughes, Associate Director, DECS Translational Sciences, AstraZeneca, 

UK 

Successful application of our newly acquired insight into the aetiological 

pathways at play in complex disease is largely predicated on the quantitative 

assay of a variety of novel biomarkers. Such biomarkers require qualification 

for this purpose and the qualification cycle needs extend throughout the drug 

lifecycle. 

Moving from Biomarker to ‘Fit for Purpose’ Assay 

Caroline Dive, Clinical and Experimental Pharmacology Group Leader, Paterson 

Institute for Cancer Research, UK 

The Development of Robust Validated Assays 

Henrik Winther, Director R&D, DAKO, Denmark 

Assay Deployment from Early Development to Proof of Concept 


14:00-15:30 Session 0107 

CLINICAL UTILITY AND IMPLEMENTATION - THE GATEKEEPER FOR 

SUCCESSFUL PERSONALISED MEDICINE 




Despite the technical sophistication of modern biomarker analyses, the 

rationale for personalised medicine depends entirely on the ability of predictive 

information to change care pathways. As such assessment of clinical utility 

remains the primary filter for recognising the value of personalised healthcare 

projects and should inform consideration of biomarker applications even in the 

earliest stages of drug development. 

Barriers to Uptake for Personalised Medicine: Understanding the value of 

stratifications in practice 




16:00-17:30 Session 0108 

PERSONALISED MEDICINES FOR THE REAL WORLD 


Ron Zimmern, Chairman, PHG Foundation, UK 

impact it has on medical practice in a global setting prepare us for the changes 

engagement with predictive data at the individual level will bring. 

Personalised Medicine: An introduction to real-world perspectives and needs 

Ron Zimmern, Chairman, PHG Foundation, UK 


Theme 2 | Securing Approvals in a Changing 

Environment 

Henrik Kim Nielsen, Corporate Vice President, Novo Nordisk A/S, Denmark 

Tomas Salmonson, Vice Chairman, CHMP, Director Scientific and Regulatory 

Strategies, MPA, Sweden 

This theme will address the changes in the European regulatory environment, 

discuss the appropriateness of the current level of regulations and suggest 

some of the strategies the pharmaceutical industry can take to secure 

competitive approvals. Special aspects of approvals will be addressed in 

separate sessions: Benefit/risk assessment from a regulatory point of view, 

advanced therapies, and a review of the recent new approaches to maintaining 

the approvals (variations). Finally, two sessions will deal with how the 

regulatory environment is able to meet the needs of the patient both in terms 

of strategies for making the product available to all patients and how the 

information need of the patient is met. 


09:00-10:30 Session 0201 

THE FUTURE OF THE EU REGULATORY LANDSCAPE 


Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, 

Pfizer AB, Sweden 

The regulatory environment is highly dynamic with new challenges appearing 

constantly, which demands that the regulatory framework is able to adapt to 

changes within reasonable time. The impact on the European regulatory system 

will be discussed in a panel session by representatives from the Commission, 

EMA, a NCA and industry. Examples of topics that may be discussed are, the 

proportionality of the framework, the many aspects of the globalisation of 

pharmaceutical operations, what consequences might be expected long-term 

from the switch to DG SANCO, the appropriateness of the framework for medicinal 

product + companion diagnostic, etc. 

Noel Wathion, Head of Patient Health Protection, European Medicines Agency, EU 

Susan Forda, Vice President, International Regulatory Affairs, Eli Lilly, UK 

Rolf Bass, Professor of Pharmacology and Toxicology, University Berlin - Charité, 

Germany 

Tomas Salmonson, Director Scientific and Regulatory Strategy, Vice-chair CHMP, 

Medical Products Agency (MPA), Sweden 

European Commission speaker invited 

The emergence of scientific information as to methodologies for patient 

stratification is just the beginning of the changes that Personalised Medicine 

will bring to medical practice. Real-world examples of stratification and the

18 

THEME 2 


11:00-12:30 Session 0202/0302 

DECISION-MAKING PROCESS OF BENEFIT/RISK ASSESSMENT – A 

COLLABORATIVE FRAMEWORK APPROACH (JOINT WITH THEME 3) 


Iman Barilero, Vice President, Regulatory Development Strategy & Policy, H. 

Lundbeck A/S, Denmark 

The session will provide an opportunity to discuss the CHMP work on 

methodologies for B/R assessment and address the views from industry and 

patients. 

The use of a consistent and transparent B/R assessment framework for 

decision making would facilitate communication of the rationale for decisions, 

but it should retain sufficient flexibility. An area of potential research is the 

further development of quantitative tools, which should not lead to a B/R ratio 

expressed as one single figure. 

Another area that requires deep reflection is how the B/R assessment will be 

applied in the so-called ‘staggered’ approval and how this approach will be 

integrated in the newly proposed B/R management plan. The implications of 

such an approach on the R&D investment should be assessed. 

CHMP Progress with the Methodologies and Decision-Making of B/R 

Assessment during the Product Lifecycle 

Eric Abadie, Chair, CHMP, Chair Pharmacogenomics Working Party, European 

Medicines Agency; General Directorate, Afssaps, France 

Industry Views on the Way Forward to Support Effective Decision Making of 

Benefit/Risk Assessment in Context of Global Development Programmes 

Iman Barilero, Vice President, Regulatory Development Strategy & Policy, 

H. Lundbeck A/S, Denmark 

Contribution of Patient’s organisation in the Decision-Making of B/R 

Assessment 

Patient representative invited 

14:00-15:30 Session 0203 

STRATEGIES TO OBTAIN COMPETITIVE APPROVALS IN A CHANGING 

ENVIRONMENT 


Henrik Kim Nielsen, Corporate Vice President, Novo Nordisk A/S, Denmark 

Six presenters will give their input on how to navigate in the current 

regulatory environments in order to achieve competitive approvals. After a 

brief presentation by the speakers, they will be available in break-out groups 

for in-depth discussion of their topic. 

A Good Start is Half the Battle: Exploiting the regulatory potential of known 

active substances by proactive and intelligent strategic planning 

Sabine Ingrid Hauk, Managing Director, Pharmalex GmbH, Germany 

Strategies for Navigating the European Regulatory Landscape 

Victoria English. Editor, Med Nous, UK 

Orphan Designation of Nimorazole as a Hypoxic Radio Sensitiser in the 

Treatment of HNSCC Patients Undergoing Radiotherapy 

Hanne Damgaard Jensen, CEO, Regunic, Denmark 

Simultaneous Submission in US, EU and Japan 

Mrs. Lene Thrane, Regulatory Project Director, Novo Nordisk A/S, Denmark 

The Timing of CPP Use and the Impact on Regulatory Approvals and Patient 

Access to Medicines in the Emerging Markets 

Lawrence E Liberti, Executive Director, CMR International Institute for 

Regulatory Science, USA 

Charting a Course through Shifting Global Regulatory Tides – How Sponsors 

Can Plan Today for the Changes of Tomorrow 

Geoff Fatzinger, Executive Director Regulatory Affairs Europe & Asia Pacific, 

INC Research, UK 

16:00-17:30 Session 0204 

DEVELOPING ADVANCED THERAPY MEDICINAL PRODUCTS – CHALLENGES 

AND OPPORTUNITIES 


Catarina Edfjäll, Senior Director, Regulatory Affairs Europe, Celgene 

International SARL, Switzerland 

This session will cover the functioning and experience to date of the work 

of the EMA Committee on Advanced Medicines on scientific advice and 

marketing authorisations as well as industry experience with developing 

ATMPs and interaction with the CAT. 

CAT Procedural Updates and Experiences 

Patrick Celis, Scientific Administrator, Scientific Committee Support, European 


Practical Steps towards a Marketing Authorisation for a Gene-Therapy 

Product 

Maureen Graham, Managing Director, Diamond BioPharm Ltd., UK 

CAT View 

CAT speaker invited 


09:00-10:30 Session 0205/1405 

IMPLEMENTATION OF THE REVISED VARIATIONS REGULATION – ARE THE 

OBJECTIVES BEING MET? (JOINT WITH THEME 14) 


Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global 

Regulatory Affairs, GlaxoSmithKline, UK 

The revised Variations Regulation (EC No. 1234/2008) applied from 1st January 

2010 to marketed authorisations granted through a mutual recognition process, 

decentralised procedure or centralised procedure. The overall objectives of 

this revision were to provide a simpler, clearer and more flexible legislative 

framework governing variations. 

Based on 15 months' experience, industry and regulatory experts will 

provide a perspective on whether these objectives are being met. Specific 

considerations will be given to experience on procedural aspects, managing 

CMC changes, and implications for e-Submissions. 

The Revised Variations Regulation - Are the new ideas at life? 

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

Germany 

Implementation of the Updated EU Variation Regulation – Simpler, clearer 

and more flexible? 

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

Denmark

THEME 2 

19 


Challenges and Opportunities for E-submissions 

Remco Munnik, Regulatory Affairs Information Manager, Sandoz, B.V., The 

Netherlands 

11:00-12:30 Session 0206 

TOWN HALL MEETING – MEET THE REGULATORS 

Moderator: 


The Town Hall Meeting is an open interactive session where participants can 

ask key decision makers in the European Regulatory system burning questions. 

The panel will include representatives from the European Medicines Agency, 

National Competent Authorities and a patient organisation. The topics/ 

questions discussed are decided by the attendees and should be related to: 

• Responsibility of the Agencies in the EU network 

• Authorisation and Maintenance of Medicinal Products; Benefit/Risk 

Methodologies 


• International Cooperation and Inspection-Related Issues 

• Electronic Submission 

• The Role of Patient Organisations 

Responsibilities of the Agencies in the EU Network 


EU 

Aginus Kalis, Chair HMA-MG, Executive Director, Medicines Evaluation Board 


Authorisation and Maintenance of Medicinal Products; Benefit/Risk 

Methodologies 


Eric Abadie, Chair CHMP, Chair Pharmacogenomics Working Party, General 

Director, Afssaps, France 

Truus Janse-de Hoog , Chair CMD(h), Staff member MEB, European cluster, 



June Raine, Director, Chair PhVWP, Director, Division of Vigilance Risk 

Management of Medicines, MHRA, UK 



International Cooperation and Inspection-Related Issues 


Electronic Submission 


Agency, EU 

The Role of Patient Organisations 

Albert Van der Zeijden, Board Member, International Alliance of Patients 

Organisations, UK 

14:00-15:30 Session 0207 

MEETING THE INFORMATION NEEDS OF THE PATIENT 


Trine Moulvad, Manager, Novo Nordisk A/S, Denmark 

guideline while Agencies and Health Care professionals work on improving 

the communication on benefit-risk assessments and information to patients 

to improve treatment adherence. The session will discuss what information 

patients really need and how involved patients are in making decisions about 

their medicines. 

How to Comply with the Readability Guideline 

Dominique Westphal, European Expert, Paul-Ehrlich-Institut (PEI), Germany 

Communicating Benefit-Risk Assessments and Information from Agencies 

and HCPs to Patients 

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

Patients: How involved are they in the decision about their medicines? 

Lawrence Berry, CEO, Datapharm, UK 

16:00-17:30 Session 0208 

HOW TO MAKE THE PRODUCT AVAILABLE TO THE PATIENT 


Katie Harrison, Associate Director Regulatory Intelligence and Policy, Baxter 

Healthcare LTD., UK 

The key need for many patients is to have access to the product. How can 

this be achieved e.g. through compassionate use programs or early approval 

options? 

Practical Aspects of Managing Compassionate Use Programs – Industry's 

Perspective 

Mats Ericson, Regulatory Affairs Director, Amgen Ltd., France 

New Regulatory Background on Compassionate Use 

Thomas Sudhop, Head of Clinical Trials and Clinical Inspections Unit, BfArM, 

Germany 

What the Patient Needs 


Panel with Anthony Humphreys, Head of Regulatory, Procedural and 

Committee Support, European Medicines Agency, EU 

11th Conference and 

Exhibition on European 

Electronic Document 

Management - 

The New Frontiers 

1-3 December 2010 

Nice, France 

How do we secure approvals in a changing environment while meeting the 

information needs of the patient? 

The MAH has to comply with the requirements of the EU readability

20 

THEME 3 


Theme 3 | Patient Safety: From Data Collection 

and Integration to Benefit/Risk Analysis and Risk 

Minimisation 

Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), 


Philippe Close, Chief Safety Officer, Novartis Pharma AG, Switzerland 

In the words of the Institute of Medicine (IOM) report, patient safety is best 

achieved by adopting a culture of safety across all involved stakeholders. 

In the past, this culture has been limited to organisational commitments to 

continually improve safety and to professionals from various disciplines of the 

health care sector. A mounting challenge faced by all professionals in the field 

of medicinal products is an ever expanding field that requires gathering and 

assessing safety data (e.g. globalisation, web media, new databases literature) 

and organising them into comprehensive safety knowledge that can then turn 

into actions in the form of risk management with appropriate minimisation 

activities. Important initiatives are underway to facilitate safety data collection 

and interpretation including new technologies, safety data sources, legislative 

changes and scientific developments that aim at improving the benefit/risk 

balance of drugs. New concepts about benefit/risk assessment are emerging 

that involve complex and multidisciplinary decision-making processes that rely 

on iterative interactions between all stakeholders, not just professionals. There 

is a growing need to integrate both the benefits and the risks during the entire 

market life of a drug and to communicate the results of such integration to 

the public as a whole. This includes facilitating the reporting of adverse events 

on a global basis through as many sources as possible, then managing risks, 

minimising them effectively (i.e. documented positive outcome) in order to 

prevent incidents that may cause undue harm, and also communicating safety 

risks in the context of expected benefits. In providing all these deliverables, 

pharmacovigilance should now establish stronger connections with patients 

and their wishes, for instance in terms of communication. The objectives of this 

theme are to provide the professionals working in this area with the newest 

insights on gathering the necessary data, to interpret them into the context of 

benefit, manage them effectively (i.e. with documented positive outcome) and 

communicate them to a broader public audience including patients. 


09:00-10:30 Session 0301 

GLOBALISATION OF SAFETY: PHARMACEUTICAL AND DRUG SAFETY IN 

EMERGING ASIA 


Stewart Geary, Vice President, Eisai Co. Ltd., Japan 

This session will present the most recent developments in drug safety management, 

especially post-marketing pharmacovigilance and risk management, in Asia with 

special attention to the emerging countries of China and India. The question of 

gaps in approaches to drug safety internationally will be taken up including how to 

bridge those gaps to maintain compliance with requirements in Europe and other 

ICH territories. Special characteristics of safety issues in the Asian region will also 

be discussed along with their potential impact on drug safety globally. 

Bridging the Gaps between the EU and Asia including Japan in 

Phamacovigilance Requirements 

Shinya Yamauchi, Operating Officer, Otsuka Pharmaceutical Co. Ltd., Japan 

Pharmacovigilance in China 

Conny Mo, Head, US Clinical Trial SAE Case Processing Department, Safety 

Evaluation and Reporting WSRO, Pfizer R&D CO. Ltd. China 

11:00-12:30 Session 0202/0302 

DECISION-MAKING PROCESS OF BENEFIT/RISK ASSESSMENT – A 

COLLABORATIVE FRAMEWORK APPROACH (JOINT WITH THEME 2) 


Iman Barilero, Divisional Director, Regulatory Development Strategy and 

Policy, H. Lundbeck A/S, Denmark 

The session will provide an opportunity to discuss the CHMP work on 

methodologies for B/R assessment and address the views from industry and 

patients. 

The use of a consistent and transparent B/R assessment framework for 

decision-making would facilitate communication of the rationale for decisions, 

but it should retain sufficient flexibility. An area of potential research is the 

further development of quantitative tools, which should not lead to a B/R ratio 

expressed as one single figure. 

Another area that requires deep reflection is how the B/R assessment will be 

applied in the so-called ‘staggered’ approval and how this approach will be 

integrated in the newly proposed B/R management plan. The implications of 

such an approach on the R&D investment should be assessed. 

CHMP Progress with the Methodologies and Decision-Making of B/R 

Assessment during the Product Lifecycle 



Industry Views on the Way Forward to Support Effective Decision Making 

of Benefit/Risk Assessment in Context of Global Development Programmes 

Iman Barilero, Vice President, Regulatory Development Strategy & Policy, H. 

Lundbeck A/S, Denmark 

Contribution of Patient’s Organisation in the Decision-Making of B/R 

Assessment 


14:00-15:30 Session 0303 

FROM RMP TO REMS: IS A GLOBAL APPROACH TO RISK MANAGEMENT 

ACHIEVABLE? 


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

Company Ltd., UK 

The requirement for effective risk management systems has now been in place 

for several years since the publication of ICH E2E and other guidelines in the 

EU, US and other countries. Whilst all stakeholders intuitively agree that risk 

management principles are the right way forward for optimising benefit risk 

for patients, the challenge remains for how companies operating in a global 

environment will ensure consistent standards across multiple countries and 

regions. In other words how to reconcile EU – RMPs and REMs. This session 

will examine how globalised risk management planning can be achieved in 

practice, taking into account transatlantic and new CIOMS initiatives. 

Transatlantic Simplification Initiative 


Global Approaches to Risk Management Planning 

Steven. F. Hobbiger, VP Neuroscience and EU QPPV, Global Clinical Safety and 

Pharmacovigilance, GSK, UK

THEME 3 

21 


Global Consensus on Risk Management - CIOMS IX 

Panos Tsintis, Medical Advisor, NDA Regulatory Sciences Ltd, UK 

16:00-17:30 Session 0304 

NEW PHARMACOVIGILANCE LEGISLATION: FACILITATION AND 

TRANSPARENCY 


Dolores Montero, Head of the Division of Pharmacoepidemiology and 

Pharmacovigilance, Spanish 

Medicines Agency, Spain 

The new Directive and Regulation on Pharmacovigilance certainly implies 

major changes in the way that both regulatory authorities and pharmaceutical 

companies currently run their activities. This session aims to introduce the 

main changes of the new legislation on pharmacovigilance to the audience, 

giving particular emphasis to the changes made for achieving an improvement 

to the efficiency to the system and the transparency of the decision-taken 

process. 

New Procedures Included in the Legislation 



Views of the European Parliament 

Linda McAvan, Labour Spokesperson, Member European Parliament, EU 

Perception of the Regulatory Process by Patients 

Greetje Goossens, European Myloma Platform, Belgium 


09:00-10:30 Session 0305 

RISK MINIMISATION 


Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, CDER, FDA, 

USA 


drugs (Acomplia, Viracept) and vaccines (MMR, Hepatitis B and HPV) suggests 

that well-prepared regulators manage emergency situation significantly better 

than unprepared ones. Is it possible to avoid the pitfalls of knee-jerk reaction? 

Is precaution always the right answer? What are the “do” and “dont's” when 

confronted to a safety event? This session will address these questions in a 

meaningful way. It will convey key lessons from state-of-the-art research 

in the field. A panel of three discussants from the regulatory, medical and 

patient perspectives will reflect on these key lessons and present best practice 

illustrations from their own experience of concrete situations. The session will 

also spell out successful approaches that may be followed when confronted 

to the more direct involvement of patients. The prevent or mitigation of future 

crises urgently requires us to deal with safety events more effectively. 

The Do’s and Don’ts of Incident Management 

Frederic Bouder, Assistant Professor, Technology and Society Studies, 

Maastricht University, the Netherlands 

Panel with: 

Pat O’Mahony, Chief Executive Officer, Irish Medicines Board, Ireland 

Herve Le Louet, Head of Pharmacovigilance Department, University Hospital 

Henri Mondor, France 

David Haerry, Representative, European AIDS Treatment Group (EATG), 

Belgium 

16:00-17:30 Session 0308 

RISK COMMUNICATION AND TRANSPARENCY IN THE 21ST CENTURY: 

LESSONS FOR PHARMA 


Ragnar Lofstedt, Director, The King’s Centre for Risk Management, The 

International Policy Institute 

King’s College London, UK 


Geoffrey Podger, Chief Executive, Health and Safety, UK 

Deborah Szafir, Head of Safety Risk Management Strategy, Roche, France 

11:00-12:30 Session 0306 

DATA SOURCES FOR PHARMACOVIGILANCE ASSESSMENT 


Stephen Evans, Professor of Pharmacoepidemiology, The London School of 

Hygiene & Tropical Medicine, UK 


14:00-15:30 Session 0307 

HOW BETTER INCIDENT MANAGEMENT PREVENTS CRISIS 


Frederic Bouder, Assistant Professor, Technology and Society Studies, 

Maastricht University, the Netherlands 

9th Middle East 

Regulatory Conference 

(MERC) 2011 

1-2 February 2011 

Amman, Jordan 

The scientific basis for balancing risks and benefits is increasingly challenged 

in an environment characterised by declining trust in regulators, a more 

demanding public and a more critical media. If not properly managed, safety 

events may escalate into full-fudged public controversies. Decisions taken 

under strain may lead to unbalanced choices that undermine rather than 

improve patients’ health. The analysis of recent public controversies affecting

22 

THEME 4 


Theme 4 | Clinical Study Endpoints and HTA/Cost 

Effectiveness 

Olivier Chassany, Medical Head, Clinical Research & Development Department, 

Assistance Publique - Hôpitaux de Paris, France 

Wills Hughes-Wilson, Senior Director, Health Policy Europe, Genzyme, Belgium 

In the context of growing requirements from health authorities, the theme aims 

to examine the possibilities of increasing the consistency between European 

Health Technology Assessment (HTA) agencies. It will also explore the 

potential to reconcile the different requirements for Marketing Authorisation 

and actual market access, as determined by reimbursement decisions. The 

second part of the theme focuses in on clinical endpoints. It will examine 

differences and similarities in the FDA and European Medicines Agency 

approaches for the assessment of Patient-Reported Outcomes (PROs). It will 

explore opportunities for further interaction between the agencies themselves 

and with industry. It will discuss the factors for a successful scientific advice 

and review the potential of Scientific Advice in the future. Lastly, it will present 

an update on the different initiatives undertaken by European and US Public- 

Private Partnerships, to reach consensus on Patient-Reported endpoints. 


09:00-10:30 Session 0401 

UPDATE ON HOW AGENCIES ASSESS THERAPEUTIC VALUE OF A PRODUCT 

AND – INCREASINGLY – THE THERAPEUTIC ADDED VALUE 



Marketing Authorisation is no longer the 'key to the market'. Without a 

successful demonstration that the product can actually add value, reimbursed 

market access, or at least, reimbursed market access at a price that makes 

sense to the manufacturer might be a just a dream. This session will examine 

the approaches that different countries take to not only the value that the 

product brings to the patients, but also what added value it brings, in relation 

to existing therapeutic options. 

Service Medical Rendered (SMR) and Added Service Medical Rendered 

(ASMR) 

Anne d’Andon, Head of Medicines Assessment, Haute Autorité de Santé (HAS), 

France 

AIFA’s System 

Guido Rasi, General Director, Italian Medicines Agency (AIFA), Italy 

11:00-12:30 Session 0402 

CAN WE MERGE TWO DIFFERENT WORLDS: REGULATORY REVIEW FOR 

MARKET AUTHORISATION AND HTA ASSESSMENT FOR REIMBURSEMENT 

DECISION? 


Wills Hughes-Wilson, Senior Director, Health Policy Europe, Genzyme, Belgium 

As regulatory review becomes just one stage in the process, there is a drive 

to bring together the scientific reviewers for the regulatory approval and 

the scientific reviewers for the HTA assessment. The European Medicines 

Agency sees this as one way forward to address the current fragmentation of 

the single EU Marketing Authorisation caused by 27 or more post-Marketing 

Authorisation reviews. But how do the national agencies see it? Is it possible 

in practice and will it address the communication gap? 

‘Not Really’ 

Industry speaker invited 

‘Maybe’ 

Regulator invited 

‘Yes’ 


14:00-15:30 Session 0403 

COMPARISON OF ENDPOINTS FOR MARKET AUTHORISATION AND 

REIMBURSEMENT: HOW CAN WE HARMONISE ASSESSMENT? 


Mira Pavlovic, Deputy Director, DEMESP, HAS Haute Autorité de Santé, France 

The endpoints needed to achieve regulatory approval might not be the same 

as those that an HTA body is looking for. What are the differences and what 

needs to be added? Will the two always be different? 

Increasing the interaction between Regulators and HTA Bodies: Towards 

easier access for innovative drugs or an increased burden to industry? 

Karim Benslimane, Regulatory Intelligence & Policy Manager, Lundbeck, France 

Integrating HTA Requirements into Drug Development 

Adam Lloyd, Senior Principal, Health Economics and Outcomes Research, IMS, 


View from the European Medicines Agency 


16:00-17:30 Session 0404 

CAN WE REACH SOME HARMONISATION AMONG EUROPE ON HTA 

REVIEW ASSESSMENT OF VALUE PRODUCT, ADDED VALUE PRODUCT AND 

REIMBURSEMENT DECISION PROCESS 


Yann Le Cam, Chief Executive Officer, EURORDIS, France 

The EUNetHTA project has 'earned its stripes' – it has gone from being a 

trial project to a full 'Joint Action', 50% funded by the Member States. Will 

it lead to potential alignment of relative effectiveness, the creation of relative 

effectiveness guidelines and, ultimately a shared long-term assessment, to 

support conditional pricing and reimbursement as foreseen by the EU High 

Level Pharmaceutical Forum? 

View from the Commission 

Jérôme Boehm, Head of Pharmaceuticals Sector, Health and Consumers 

(SANCO), European Commission, EU 

Can Clear Understanding of Individual EU National HTA Evaluations and 

Decision-Making Processes Lead to More Predictable, Transparent and 

Consistent Outcomes? 

Franz Pichler, Manager, HTA Programmes, CMR International Institute for 

Regulatory Science, UK 

From HTA to Reimbursement and Pricing: Situation in France and European 

perspective 

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

Autorité de Santé, France

THEME 4 

23 



09:00-10:30 Session 0405 

FDA GUIDANCE ON PATIENT-REPORTED OUTCOMES AND EMA’S PAPER ON 

HEALTH-RELATED QUALITY OF LIFE: DIVERGENCES AND INTERACTION 

SIMILARITIES 




Both FDA and the European Medicines Agency (EMA) have developed 

guidance on the use of Patient-Reported Outcomes (PROs). Will this support 

global development and what are the areas of similarity, difference and 

opportunities to interact with both agencies? 

Harmonising Study Endpoints for Multi-National Clinical Trials 



Harmonising the Final FDA Patient-Reported Outcomes Guidance and the 

EMA “Points to Consider” Document – What is the best way forward? 

Ingela Wiklund, Senior Research Leader, United Biosource Corporation, UK 

Impact of Health-Related Quality of Life Data (HRQL) on Health Technology 

Assessment (HTA) Process in France 

Sophie Stamenkovic, Project Leader, HAS Haute Autorité de Santé, France 

11:00-12:30 Session 0406 

ASSESSING SYMPTOMS IN GLOBAL CLINICAL TRIALS TO MEET FDA AND 

EUROPEAN MEDICINES AGENCY STANDARDS 




There is an increasing need for international clinical trials in order to gather 

together the necessary patient populations and numbers. How do the FDA 

and the European Medicines Agency’s standards facilitate such international 

clinical trials? 

Value of Evaluating Symptom Endpoints: Labels and Beyond 

Lena Ring, Associate Professor, Principal Scientist, AstraZeneca, UK 

The Regulatory Perspective: EU and US 



Meeting Regulatory Requirements in International Trials (including content 

validation – PRO issues) 

Károly Kulich, PRO Expert, Novartis Pharma AG, Switzerland 

14:00-15:30 Session 0407 

SCIENTIFIC ADVICE ON ENDPOINTS: TO COMPLY OR NOT TO COMPLY 


Dagmar Stará, Faculty of Pharmacy, Comenius University, Bratislava, Slovak 

Republic 

The value of Scientific Advice has been clearly demonstrated over its years 

of development. However, are there situations where an applicant should 

consider whether or not to comply with Scientific Advice? And what is the 

impact? 

Does Asking for Scientific Advice Increase the Probability of a Successful 

Drug Approval? 



Predictive Factors for a Successful Scientific Advice: Perspective from a 

CRO specialised in health outcomes / PRO 

Katarina Halling, Senior Scientist, PRO Consulting, Sweden 

Scientific Advice on PRO Endpoints: Some Experiences and Thoughts from 

an Industry Perspective 

Margaret Tabberer, Global Health Outcomes, GlaxoSmithKline, UK 

16:00-17:30 Session 0408 

PUBLIC-PRIVATE PARTNERSHIPS – INITIATIVES TO REACH CONSENSUS ON 

PATIENT-REPORTED ENDPOINTS 


Michel Goldman, Executive Director, IMI, Professor of Immunology at the 

Faculty of Medicine of the Université Libre de Bruxelles (ULB), Belgium 

There are several Public-Private Partnerships (PPPs) in development. They 

could hold the key to reaching consensus on the tools to be used – but is 

everyone developing their own tools? How much overlap or interaction is 

there in reality? Is it needed? And, if so, how can this be brought to bear? 

European Innovative Medicines Initiative on Chronic Pulmonary Disease 

(COPD) 

Caterina Brindicci, Chiesi Group, Italy 

US Critical Path Initiative on Irritable Bowel Disease (IBI) 


Collaborative Efforts for Developing Patient-Reported Outcome Tools- 

Examples, opportunities, challenges 

Asha Hareendran, Senior Research Scientist, United Biosource Corporation , 


New at the EuroMeeting 

GCP Forum 


09:00-12:30 

See page 43 for session details 

Town Hall Session: 

Meet the Regulators 


11:00-12:30 

See page 7 for session details

24 

THEME 5 


Theme 5 | Wider Access (Generics/Switching) 


Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, 

Belgium 

How can we meet the patients' need and expectations? This question will be 

analysed for generics and self-care medicine. The efficiency of the existing 

regulatory system (licensing procedures, handling of the lifecycle, switchprocedures) 

will be discussed. Pros and cons will be identified in order 

to optimise access to medicines - also in developing countries – as well 

as affordable treatment by generics and biosimilars; with a high level of 

information to patients and consumers, which is especially important for nonprescription 

medicines. The impact of the new changes in the pharmaceutical 

landscape – a new Directorate General (DG), a new European Commissioner, 

new strategic roadmaps as well as new pieces of legislation – will be elucidated. 


09:00-10:30 Session 0501 

SWITCHING: IS THERE AN IDEAL ROUTE? 


Hubertus Cranz, Director-General, AESGP, Belgium 

This session will review the existing procedures (CP, DCP-MRP, national) that can 

be used to switch a medicine, the conditions to be met and their pros and cons in 

terms of resulting access, resources needed etc. What are the influencing factors 

companies consider when choosing their ‘switching pathway’ and what would be 

needed to make it the 'perfect route(s)'. These views will be confronted with that 

of the authorities at national and EU level. 

The Centralised Procedure and Switch 



View of a National Authority 

June Raine, Director, Division of Vigilance Risk Management of Medicines, MHRA, 


What are the Important Factors when Selecting a Procedure? 


11:00-12:30 Session 0502 

ARE NEW SWITCHES IN LINE WITH THE EXPECTATION OF THE 'EMPOWERED 

PATIENT'? 


Anthony Humphreys, Head of Regulatory, Procedural and Committee Support, 


A number of new switches-in-class have born lately in the field of migraine, 

obesity, BPH, etc. Are these meeting patients' expectations? How is patient 

need/expectation known? What are consumers after? Are there gaps not met in 

terms of self-care? What are the criteria that matter for consumers and patients 

in a switching process both by industry and regulators? All these challenging 

questions will be addressed in this session giving a prominent role to patients 

and consumers. 

Switch: What could be on the horizon? 

Stephen Mann, Pharmaceutical Consultant, Co-Editor, SelfCare Journal, UK 

Voice of the Patients/Consumers 


14:00-15:30 Session 0503 

CHANGING REGULATORY ENVIRONMENT: IMPACT ON THE SELF-CARE 

SECTOR 


Shirley Norton, Deputy Director, Vigilance and Risk Management Division, 

MHRA, UK 

The last year or so has brought a number of changes in the pharmaceutical 

landscape: a new commissioner, a new DG, new strategic direction of the 

Agency and of the HMA, early experience with the variation regulations and 

possibly new legislations in pharmacovigilance and in the context of falsified 

medicines. The session will reflect on the impact these changes may have on 

the self-care sector and how it may adapt. 

Overview of the New Legislative and Regulatory Landscape 


Will the Self-Care Industry be Better Off? 


Views of a National Competent Authority 


16:00-17:30 Session 0504 

IS THE PATIENT/CONSUMER ADEQUATELY INFORMED? 



We are witnessing a breathtaking evolution of new forms of digital 

communication. All of this is unfolding so quickly that we do not have time 

to pause and reflect on what is happening. Providing 'the right information, 

in the right place, at the right time' is even more crucial in a non-prescription 

environment where the intervention of a healthcare professional is optional. 

This session therefore proposes to explore amongst industry, regulators and 

consumer organisations ways to improve the quality of the conventional 

forms of communication on non-prescription medicines, to debate ways 

to disseminate such information more effectively and the potential for 

individualising such information to the consumer/patient needs. 

Industry View 

Helen Darracott, Director of Legal & Regulatory Affairs, PAGB, UK 

The Regulators’ Perspective 

Isabelle Moulon, Head of Medical Information, European Medicines Agency, 

EU 

Consumers’ Perspective 

Ilaria Passarani, Health Policy Officer, BEUC -The European Consumers’ 

Organisation, Belgium 

The Patient’s Point of View 

Ian Banks, President, European Men’s Health Forum, UK

THEME 5 

25 



09:00-10:30 Session 0505 

SUPPLY OF QUALITY MEDICINES TO DEVELOPING COUNTRIES 


Milan Smid, Technical Officer, Prequalification of Medicines Programme, WHO, 

Switzerland 

Needs of essential medicines and procurement by international organisations 

will be presented to explain opportunities of involvement in supplies to 

developing countries. QA policies of international organisations, mechanisms 

of WHO prequalification and EU ‘Article 58’ assessment will be discussed. 

Assurance of Availability of High Quality Medicines in Developing Countries 


WHO Prequalification Programme for Essential Medicines 

Lembit Rago, Coordinator, Quality Assurance and Safety, Medicines, Policy, 

and Standards, WHO, Switzerland 

EU Contribution to the Availability and Quality of Medicines in Low Income 

Countries 


11:00-12:30 Session 0506 

HOW TO INCREASE ACCESS TO BIOSIMILAR MEDICINES 


Suzette Kox, Senior Director, Scientific Affairs, EGA, Belgium 

This session looks at the reasons for the generally slow introduction of biosimilar 

products into clinical practice and discusses approaches on how this new class 

of products should be optimally regulated in order to deliver the maximum 

benefit to society and patients. Views from the European Commission - DG 

Enterprise and Industry, national authorities and the biosimilar medicines 

industry will be presented. 

European Commission DG Enterprise and Industry Views and Activities on 

How to Increase Access to Biosimilar Medicines 

Christophe Roeland, European Commission, EU 

Perspective of a Member State’s Medicines Agency 


How to Increase the Introduction of Biosimilar Medicines into Clinical 

Practice: A biosimilars manufacturer’s point of view 

Sandy Eisen, Chief Medical Officer, TEVA Pharmaceuticals Europe, UK 

14:00-15:30 Session 0507 

HOW TO IMPROVE THE CURRENT REGULATORY FRAMEWORK IN ORDER TO 

INCREASE ACCESS TO GENERIC MEDICINES 


Beata Stepniewska, Director of Regulatory Affairs, EGA, Belgium 

The possibility to provide EU citizens with affordable treatment by generic 

medicines on the next day following patent expiry should be in the interest of 

all involved parties: patients, healthcare professionals, health authorities and 

industry. To achieve this objective, there is a need for an efficient regulatory 

system allowing access to the market in a timely manner. The objective of 

the session is to discuss possible ways to remove the hurdles and to create 

a clear, open market that will benefit patients, spur innovation and generate 

considerable savings with the view to maintaining a sustainable EU healthcare 

system. 

The point of view of a representative of the competent regulatory authority 

and the generic medicines industry will be presented, followed by a panel 

discussion with additional panelists from the European Commission and a 

consumer organisation. 

Possible Ways to Improve the Current Regulatory Framework for Generic 

Medicines: 

Industry View 

Beata Stepniewska, Director of Regulatory Affairs, EGA, Belgium 

The Regulator’s Perspective 

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



Panel Discussion with Ilaria Passarani, Health Policy Officer, BEUC - 

The European Consumers’ Organisation, Belgium 

16:00-17:30 Session 0508 

PROS AND CONS OF THE CURRENT DECENTRALISED PROCEDURE FOR 

GENERIC APPLICATIONS 



The current European regulatory framework offers different approaches for 

marketing authorisation applications (e.g. CP, DCP) for generic medicinal 

products. The complexity of continuously changing regulatory requirements 

(e.g. guideline for BE-studies, new variation regulation, pharma package) 

applicable to generic applications will be discussed and the latest updates 

presented. 

Pros and Cons of the Current DCP for Generic Applications 

Maren Von Fritschen, Director Regulatory Affairs, PharmaLex, Germany 


2nd Global Animal 

Health Conference 

Global Availability of Veterinary 

Medicines - Providing a Climate 

for Science and Innovation 

23-24 March 2011 

London, UK

26 

THEME 6 


Theme 6 | Engaging the Research World! 

Non-Clinical Research and Development 

Per Spindler, Director, Biopeople, University of Copenhagen, Denmark 

Nancy Claude, Director of Drug Safety, IRIS, France 

Pre-clinical research and development is central to product innovation in 

the healthcare business. The stakeholders involved are academics, contract 

research, regulators and industry. They need in many cases to work together to 

leverage on synergies enabling smarter and faster early product development. 

Product innovation in our sector is massively embedded in regulatory and 

streamlined processes; however to do the early steps smarter and faster 

the research world must be engaged. A pallet of contemporary topics have 

been selected that will guide and inspire you in the pre-clinical research and 

development of novel healthcare products. 


09:00-10:30 Session 0601 

INTERNATIONAL STRATEGY FOR NON-CLINICAL CONSULTANTS 


Elisabeth C. Goodman, Principal Consultant, RiverRhee Consulting, UK 

This session presents three case studies which address respectively: The 

challenges of building a non-clinical drug safety business in an international 

context; how using an organised global network of expert level consultants can 

facilitate successful navigation of the regulatory requirements for entry into Phase 

1; and how a CRO can engage its whole organisation in creating greater value 

for its customers, streamlining its processes and building a stronger people and 

culture infrastructure. 

International Strategy: Experience of a Non-clinical CRO 

Roy Forster, Scientific Director, CIT, France 

Using an Organised Global Network of Experts to Address Regulatory 

Requirements for Entry into Phase 1 

Maurice G. Cary, CEO and founder, Pathology Experts LLP, Switzerland 

Building Quality in a Time of Change 

Mark S. Duxon, Chief Executive Officer, Porsolt and Partners Pharmacology, France 

11:00-12:30 Session 0602 

NON-CLINICAL EVALUATION OF DRUG-INDUCED HEPATOTOXICITY 


Beatriz Silva Lima, Chair SWP; Professor, Pharmacology, iMED-UL, Lisbon 

University and INFARMED, Portugal 

Hepatotoxicity constitutes one of the major causes for late attrition during the 

development process of pharmaceuticals. In addition, many drugs have been 

withdrawn from market due to liver toxicity. The need for earlier and better 

prediction is needed. Recently, the EMA/CHMP/SWP issued a discussion paper 

where the approaches and strategies for prediction of hepatotoxicity in animal 

studies are discussed. The session will address current discussions and progress in 

the area. The views of industry and regulatory scientists will be explained 

Impact of Hepatotoxicity on the Attrition of Drug Development - Lessons 

learned in the Post-marketing Setting 

Marku Pasanen, Professor, University of Eastern Finland, Finland 

Reinforcing the Predictive Role of the Non-Clinical Testing: The CHMP/SWP 

discussion paper on hepatotoxicity 


Germany 

The Joint Efforts of Industry and Academia to Reinforce Hepatotoxicy 

Prediction Including the Value of Regulatory Measures 


14:00-15:30 Session 0603/1303 

SAFETY ASPECTS IN THE DEVELOPMENT OF VACCINES (JOINT WITH 

THEME 13) 


Jan Willem van der Laan, Senior Assessor Section on Safety of Medicines and 

Teratology Centre, National Institute for Public Health and the Environment 

(RIVM), The Netherlands 

There is an increasing awareness that vaccines have their own characteristics 

in safety aspects. The recent introduction of adjuvants in marketed products 

has underlined this. The risk of an increase in autoimmune phenomena and the 

safe use of vaccines during pregnancy are hot topics. The WHO will present its 

perspective on the use of adjuvants. 

WHO Perspective on Adjuvants in Vaccines 

Martin Howell Friede, Technical Officer, Initiative for Vaccine Research, WHO, 

Switzerland 

Adjuvants and the Potential Risk of Autoimmunity 

Sarah Gould, Non Clinical Safety Division, Sanofi Pasteur, France 

Vaccines and Pregnancy 




16:00-17:30 Session 0604 

BIOBANKING: LOGISTICS AND SAMPLES HANDLING 


Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services 

GmbH, Germany 

Handling frozen specimens is of increasing importance in clinical research. 

This session willo present strategies and solutions in order to ensure both that 

frozen specimens are correctly collected, shipped and stored and that these 

samples arrive in stable condition at the laboratory where reliable lab results 

are expected. 

A Biopharmaceutical Company Perspective: Strategies for improving the 

management of global samples 

Julie Corfield, Biobank Head, AstraZeneca R&D, UK 

A Biorepository Perspective: How the development of global standards for 

sample management could improve clinical trial outcomes 

Lori Ball, Chief Operating Officer, BioStorage Technologies, USA 

A Central Laboratory Perspective: How to successfully handle pre-analytical 

factors such as logistics and frozen storage to achieve reliable laboratory 

results 

Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services 

GmbH, Germany


27 



09:00-10:30 Session 0605 

NON-CLINICAL ASPECTS OF FIRST-IN-HUMANS 


David Jones, Expert Pharmacotoxicologist, MHRA, UK 

The session will cover non-clinical support for first-in-human trials, including 

first-in-paediatrics clinical trials. 

Non-Clinical Aspects of First-In-Humans – Has ICH M3R2 made any 

difference? 

David Jones, Expert Pharmacotoxicologist, MHRA, UK 

First-In-Paediatrics Trials – Are studies in juvenile animals ever needed? 

Paul Baldrick, Head of Regulatory Affairs, Covance, UK 

First-In-Human Trials with Biological Compounds 

Maggie Dempster, Safety Assessment, GlaxoSmithKline, UK 

11:00-12:30 Session 0606 

BIOMARKERS IN NON-CLINICAL SAFETY ASSESSMENT 


Gerd Bode, Consultant, Germany 

The session will provide a comprehensive introduction and global status on the 

topic and preferably provide one or more examples of biomarkers developed 

for use in non-clinical safety assessment. 


14:00-15:30 Session 0607 

THE NON-CLINICAL DEVELOPMENT OF ANTI-CANCER PHARMACEUTICALS 



Germany 

The new ICH S9 guideline on 'Non-Clinical Development of Anti-cancer 

Pharmaceuticals' will be presented and information will be given to assist in 

the design of an appropriate program of pre-clinical and clinical studies for the 

development of anticancer drugs. 

ICH S9: Non-clinical Development of Anti-cancer Pharmaceuticals 


Germany 

Industry Experience with Non-clinical Development of Anti-cancer Drugs 

Hermann Schweinfurth, Head of Non-Clinical Drug Safety, Bayer Schering 

Pharma AG, Germany 

16:00-17:30 Session 0608 

CONTEMPORARY ISSUES IN NON-CLINICAL DEVELOPMENT OF 

BIOTECHNOLOGY-DERIVED PRODUCTS 


Jennifer Sims, Head of Preclinical Development, Novartis Pharma AG, 

Switzerland 

This session will review any updates to the ICH S6 guideline and provide one 

or more cases to illustrate and guide on the principles of safety assessment of 

biotech products. 


Theme 7 | Statistics across the Drug Lifecycle 

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

Switzerland 

Robert Hemmings, Statistics Unit Manager, MHRA, UK 

The current R&D process is facing significant challenges: There is a need 

to develop efficacious and acceptably safe drugs more efficiently, and to 

improve in the early identification of drugs that will ultimately fail to prove a 

favourable benefit/risk profile. Sound statistical methods can play a major role 

in systematically generating knowledge in terms of both design and conduct 

of an individual study, and design and decision making across the entire 

lifecycle of a medicinal product. This theme will explore statistical approaches 

to improve the efficiency with which medicines are developed and monitored. 

This includes a thorough discussion of how to optimise implementation of 

established and new methodology and their applicability in a highly regulated 

environment. The theme aims to provide a forum for discussion between 

industry, academic and regulatory thought leaders. Relevant experience will 

be shared and discussed, reflecting on lessons learned. Recommendations for 

best practice will be developed. 


09:00-10:30 Session 0101/0701 

TRIAL DESIGN AND INTERPRETATION FOR PERSONALISED HEALTHCARE – 

DELIVERING C21 DRUG DEVELOPMENT (JOINT WITH THEME 1) 



The emergence of new complex diagnostic technologies challenges traditional 

ways of interpreting the output from clinical trials. Successful Personalised 

Medicine relies on our being able to understand exactly what biomarker data is 

telling us and apply this to clinical development decisions. 

Statistic Approaches to Data analysis for PHC- What does the data tell us? 


High Dimensional Data – What do we mean? 

Bryn Williams-Jones, Associate Research Fellow, Head of e-Biology, Pfizer Global 

Research & Development, UK 

Bio Informatic Tools for Complex Data 

Tom Freeman, Group Leader, The Roslin Institute, R(D)SVS, Division of Genetics 

and Genomics , University of Edinburgh, UK

28 

THEME 7 


09:00-10:30 Session 0702 

USING INDIRECT COMPARISONS IN ASSESSMENT OF CLINICAL DATA 


Michael K. Williams, Safety Data Expert, GlaxoSmithKline, UK 

As the requirement for cost-effectiveness and risk/benefit analysis grows, it 

is important that the statistician takes into account all the information that is 

available from a variety of sources, to ensure we have as complete a picture 

as possible. This often means combining results or data from diverse sources, 

which may prove difficult unless we use indirect comparisons. In this session, 

three examples of how this methodology has been applied will be presented to 

show how it is possible to combine this data and obtain an accurate estimate 

of treatment effects. 


14:00-15:30 Session 0703 

RECENT DEVELOPMENTS IN SOFTWARE SOLUTIONS FOR ADAPTIVE TRIAL 

DESIGNS 


Frank Bretz, Hannover Medical School, Germany / Novartis Pharma AG, 

Switzerland 

Adaptive designs have received increasing attention because of their potential 

to enable more efficient drug development, especially in view of the recently 

released draft FDA guidance on this topic. In the recent past, software 

solutions for adaptive trial designs have been released, which address different 

questions and target different development phases. With the proposed 

session we would like to bring key players together to contrast open source vs. 

commercial solutions for exploratory vs. confirmatory adaptive trial designs. 

Open Source Software Solutions for Exploratory Studies 

Björn Bornkamp, Development Statistical Methodology, Novartis Pharma AG, 

Switzerland 

Commercial Software Solutions for Exploratory Studies 

Tom Parke, Head of Clinical Trials Solutions, Tessella Support Services, UK 

Open Source Software Solutions for Confirmatory Studies 

Tim Friede, University of Göttingen, Germany 

Commercial Software Solutions for Confirmatory Studies 

Gernot Wassmer, ADDPLAN, Germany 

FDA panelist invited 

16:00-17:30 Session 0704 

COMMON ISSUES AT SAWP (SCIENTIFIC ADVICE WORKING PARTY) 


Spiros Vamvakas, Head of Scientific Advice, European Medicines Agency, EU 

Scientific advice given by EMA/CHMP frequently includes advice to questions 

on clinical trial methodology, including design of pivotal studies and proposed 

statistical methodology. The acceptability of each proposal has to be judged on 

its own merits in the context of the corresponding development programme, 

but some issues emerge repeatedly. The regulatory view on a selection of 

issues often considered unacceptable or commonly missing important aspects 

of justification will be presented for discussion. 



09:00-10:30 Session 0705 

QUANTITATIVE APPROACH FOR BENEFIT/RISK–CHALLENGES AND 

OPPORTUNITIES 


Stephen Evans, Professor of Pharmacoepidemiology, The London School of 

Hygiene & Tropical Medicine, UK 

Benefit/risk decisions rely on the qualitative evaluation of quantitative 

approaches applied to the wealth of data collected in clinical trials and 

epidemiological studies. It is hypothesised that decision making can be better 

informed and made with greater consistency and transparency if quantitative 

methods are also applied to the benefit-risk trade-off, even if expert 

judgement remains the cornerstone of decision making. The latest thinking on 

methodological approaches to this problem will be presented and discussed. 


11:00-12:30 Session 0706 

COMMUNICATING COMPLEX STATISTICAL RESULTS 


Ragnar Lofstedt, Director, The King’s Centre for Risk Management, The 

International Policy Institute 

King’s College London, UK 

Drug development is a complicated process, involving complex statistical 

methodology and difficult, subjective decision making. A key skill for the 

statistician is to be able to communicate their methods and findings with 

colleagues from other disciplines and, as part of a multi-disciplinary team, to 

communicate results to external stakeholders, including patients. This session 

will look into the types of communication problems facing statisticians and will 

explore possible solutions and best practices 


14:00-15:30 Session 0707/0907 

STATISTICAL COMPUTING: PROGRESS IN COMPUTATIONAL SCIENCE IN 

CLINICAL TRIALS (JOINT WITH THEME 9) 


Joachim Vollmar, Executive Consultant, International Clinical Development 

Consultants LLC, USA 

One of the most important and unrecognised issues contributing to drug 

development time and regulatory quality is the ability to acquire, store, 

analyse, share and report information needed to make the most informed and 

rapid decisions in pharmaceutical companies, contract research organisations, 

and international regulatory agencies. This session will review the current state 

of data standards, and analytical/graphical tool development, as well as user 

experiences and expectations. 

FDA’s Computational Sciences Initiative: Goals and current state of 

implementation 


Dynamic and Interactive Tools 

Michael O’Connell, Director, Life Sciences, TIBCO, USA 

Graphics 

Fabrice Bancken, Expert in Quantitative Safety , Novartis Pharma AG, 

Switzerland


29 


16:00-17:30 Session 0708 

SUBGROUP ANALYSES 


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

Switzerland 

Interpreting subgroups is a notoriously unreliable undertaking, yet discussion 

of subgroups plays a key role in the interpretation of clinical trial data as trial 

sponsors search for patients with improved efficacy or reduced harm and 

regulators concern themselves with patient groups where benefit/risk appears 

to be less favourable. The CHMP released a concept paper announcing the 

intent to develop guidance in this area. This session will present case studies 

as an introduction to the problem, an overview of the planned guidance, and 

perspectives from industry and academia on this perennial problem. 

Robert Hemmings, Statistics Unit Manager, MHRA, UK 


Theme 8 | Developing Medicines for Special 

Populations 

Angelika Joos, Director, Head Regulatory Policy, EU and Most of World, Merck 

Sharp & Dohme (Europe) Inc., Belgium 

Birka Lehmann, PDCO, Director and Professor, Head of Licensing Division 3, 

BfArM, Germany 

Regulatory requirements for special populations such as children, pregnant 

and lactating women and the elderly have received more attention over the 

past years and many developments are ongoing in this area. This theme 

will focus on the experience with the Paediatric Scheme and some special 

aspects related to increased globalisation, pharmacokinetic modelling and 

simulation as well as extrapolation of data to other populations or age groups 

with the aim of avoiding unnecessary trials in children. In addition, formulation 

development has become more important and new formulations that benefit 

children can also help reducing compliance issues or facilitate adapted dosing 

for elderly patients. As population ages throughout Europe, regulators and 

the public have become more concerned with medicine usage and impact 

of those medicines on elderly and fragile patients who may have underlying 

concomitant diseases or experience the loss of certain body functions. To 

address these concerns, clinical research needs to provide better data for those 

special age groups to inform licensing decisions and post-approval follow-up. 

Paediatrics, as well as the elderly, are usually multi-drug users and specific 

risks associated with the use of medicines in those special populations need 

to be carefully investigated and embedded into the overall risk management 

strategy of any newly developed compounds. Medicine use during pregnancy 

and lactation is another hot topic of ongoing debate and specific data 

collection to inform regulatory decision making is crucial. 


09:00-10:30 Session 0801 

INCREASING GLOBAL REGULATORY DIALOGUE 


Emma Du Four, Director, Regulatory Policy & Intelligence, Abbott Laboratories, 


Globalisation of paediatric development is necessary to make medicines 

available to children in need and to ensure that sufficient trial participants 

can be recruited in order to generate scientifically robust data. Convergence 

and acceptability of regulatory requirements is a pre-requisite to avoid 

unnecessary repetition of clinical trials in children. This session will inform 

participants about the latest developments from increasing global regulatory 

dialogue. 

FDA Involvement in Global Regulatory Dialogue 

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

Commissioner, FDA, USA 

European Medicines Agency Involvement in Global Regulatory Dialogue 



Paediatric Regulatory Network and Global Outreach 

Suzanne Hill, Scientist, Medicines, Access and Rational Use, Essential Medicines 

and Pharmaceutical Policies, WHO, Switzerland 

11:00-12:30 Session 0802 

WILL MODELLING AND SIMULATION ACCELERATE DRUG DEVELOPMENT 

FOR CHILDREN? 


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

The aim of both EU and US paediatric legislation is to allow children to benefit 

as early as possible from pharmaceutical progress and to prevent them from 

exposure to unnecessary clinical trials. Modelling and simulation (M&S) is often 

mentioned in this context. Due to the differences in the pharmacokinetics (PK) 

and/or in the PK-PD relationship between adults and children, dose selection 

in paediatric clinical trials remains a challenge. The ICH E11 guideline specified 

that extrapolation of efficacy for dose selection is justified in drugs where 

the indication, disease process and outcome of the therapy are likely to be 

comparable in adults and children. M&S plays an important role in providing 

dosing regimen recommendations in children as it is a powerful tool suitable 

for the analysis of the sparse data as collected in the paediatric trials. The 

scientific challenges in M&S will be pointed out to promote discussions on 

the requirements for improvement with special focus on the comparisons 

between the available tools and their validations. Sharing of knowledge and 

experience is now crucial to achieve the ultimate goal of determining optimal 

M&S approaches to be used in paediatric drug development 

Expectations from PK-PD Modelling and Simulation for the Evaluation of 

Medicinal Products in Children 

Gerard Pons, PDCO, Professor Clinical Pharmacology, Hospital Saint-Vincent 

de Paul, Service de Pharma, France 

Industry Views 

Ashley Strougo, Scientist, Astellas, The Netherlands 

Integration of Modelling into Drug Development 

Adam Cohen, Centre for Human Drug Research, Leiden, Netherlands 

14:00-15:30 Session 0803 

CAN BRIDGING AND EXTRAPOLATION OF DATA REDUCE THE NUMBER OF 

CLINICAL TRIALS? 


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

Germany 

From a regulatory perspective, biomarkers and mathematical functions can be 

considered as surrogates for bridging efficacy and safety between adults and

30 

THEME 8 


children or between different paediatric age groups. They must be supported 

by a robust scientific rationale, and key assumptions must be confirmed by 

clinical data. Clinical data do not always confirm the original assumptions, and 

there have been cases where drugs that worked in adults didn’t work at all in 

children. An additional methodological challenge is the use and limitation of 

patient reported outcomes in clinical investigations in children. 

Bridging between Children and Adults in Paediatric Investigation Plans (PIPs) 

Maria Isaac, Scientific Administrator, European Medicines Agency, EU 

Expected and Unexpected Clinical Limitations in Bridging from Adults to 

Children 

Sam Maldonado, Vice President and Head Paediatric Drug Development 

Center of Excellence, Johnson & Johnson, USA 

Information Leveraging: Examining the basis for extrapolation 

Steven Hirschfeld, Captain, US Public Health Service, Associate Director for 

Clinical Research, National Institutes of Health, NICHD, USA 

Panel with Paolo Tomasi, Head of Paediatric Medicines, European Medicines 

Agency, EU 

16:00-17:30 Session 0804 

RISK MANAGEMENT FOR SPECIAL POPULATIONS 


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

Belgium 

The Risk Management Plan as a tool to manage post - authorisation safety 

risk remains a relatively new tool. However experience is growing in the 

types of study required to further investigate known or potential risks or 

missing information, and the kinds of programs that can be utilised in Europe 

to manage known risks (risk minimisation).There remains little published 

experience to guide an author of risk management plans, and this is especially 

so in special populations. 

Special populations present special challenges and opportunities for the 

management of risk. 

Risks in children require attention to effects on long term growth and 

maturation, the explosion in the number of risk management plans in children 

and the difficulties of studying this population in long term randomised 

controlled trials mean that pharmacoepidemiological techniques will 

increasingly be required. 

Risk tolerance and the approach to pharmacoepidemiological studies for an 

NCE in cancer patients depend on the type, incidence and stage of cancer 

being treated. How best should you approach risk management for a cancer 

medicine? 

Risks to the foetus and pregnancy prevention remain perhaps the longest 

used and best described risk minimisation and management plans. However, 

substantial problems remain in such programs as they can be costly, restrict 

patient access and have demonstrated variable success. 

These evolving topics will be the subject of debate during this session. 

Risk Management in Cancer Patients 


Signal Detection in Paediatrics and Use of Observational Data to Assess 

Safety 

Miriam Sturkenboom, Professor of Pharmacoepidemiology, Erasmus University 

Rotterdam, Netherlands 

Pregnancy Prevention Programmes to Manage Risks in Fertile Women 

Ineke Crijns, Senior Clinical Assessor Pharmacovigilance, Medicines Evaluation 

Board (MEB), The Netherlands 

FDA panelist invited 


09:00-10:30 Session 0805 

CHALLENGES AND OPPORTUNITIES TO DEVELOP SUITABLE FORMULATIONS 


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

Based Pharm Companies, Germany 

The development of a suitable formulation is a thorough scientific process. The 

active ingredient might for example have characteristics which make it difficult 

to create an age adapted formulation. Since several excipients should not be 

used in paediatric formulations the process is even more complex if e.g. tastemasking 

is needed. At the end only technically high sophisticated formulations 

might be appropriate for certain age groups. Using these formulations for 

other patient populations such as e.g. elderly patients might be an option for 

a wider use of the required paediatric developments. 

Paediatric Formulations – Are they suitable only for children? Practical 

examples 



Medicine Formulation Challenges in Neonatal and Paediatric Care 

Steve Tomlin, Consultant Pharmacist, Children’s Services, Evelina’s Children’s 

Hospital, St Thomas Hospital, UK 

Industry Perspective on Formulation Development in Special Populations 


11:00-12:30 Session 0806 

MEDICINES FOR GERIATRIC PATIENTS 


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

It is likely that Europe (EU) will face major challenges in relation to population 

ageing brought about by low fertility levels, improved medical and social care 

leading to longer life expectancy, and the baby-boom cohorts entering the 

age of retirement. Ensuring that medicines are labelled appropriately for the 

elderly is important and this means that they should be included in clinical 

studies where special ethical, safety and efficacy issues may arise. Information 

regarding the recent work of the CHMP and the European Medicines Agency 

in the area of geriatric medicines will be provided. 

Elderly Patients: An increasingly relevant patient population 

Simonetta Alvino, Medical Director, Pharmanet Development Group, Inc., Italy 

PREDICT 


Patient Perspectives 

Barbro Westerholm, Chair, Health Expert Group, and Representative at the 

European Medicines Agency, AGE, Belgium


31 


14:00-15:30 Session 0807/1307 

HOW SHOULD THE PAEDIATRIC SCHEME BE AMENDED AND WHY? (JOINT 

WITH THEME 13) 


Angelika Joos, Director, Head Regulatory Policy, EU and Most of World, Merck 


The introduction of the Paediatric Regulation was celebrated as important 

public health milestone in 2006. Its implementation required a significant 

change in the drug development process and a mindset shift. Experience 

from industry during the first 3 years of operating under the new scheme 

will be presented. Concrete changes to current instruments will be suggested 

to address potential identified short comings in order to ensure that the 

Regulations’ objectives are effectively met. 

Reactions and perspectives from policy makers and regulators will complement 

the picture. 

Industry View of Paediatric Regulation Impact 

Ali Harrison, AstraZeneca, UK 

What changes would we need to address the findings? 

Genevieve Michaux, of Counsel, Covington and Burling, Belgium 

Does this Outcome Meet the Political Vision? 


Panel with Agnès Saint-Raymond, Head of Human Medicines Special Areas, 


16:00-17:30 Session 0808 

MEDICINES FOR PREGNANT AND LACTATING WOMEN 


Viveca Odlind, PDCO, MPA, Sweden 

Medicines usage during pregnancy and lactation is an important public health 

topic. Integration of animal and human data to assess the risks of the use 

of medicinal products during pregnancy is a critical task, which is aimed 

at reducing the induction of birth defects as far as possible. Integration of 

these assessments is essential for the labelling of a medicinal product. If 

available, clinical data from exposed breastfed infants should be mentioned 

as the conclusions of kinetic studies or non-clinical studies on the transfer 

of the active substance into milk should be provided. This session will also 

provide some perspective from the practical implications of collecting in use 

pharmacovigilance data. 

Use of Medicinal Products during Pregnancy and Lactation 


Germany 

Data Gathering and Communication Tools to Improve Safe and Effective Use 

of Drugs during Pregnancy and Lactation – FDA perspectives 


Assessment of Safety of Medicines during Breastfeeding 

Eva Jirsová, Pharmacovigilance Unit, State Institute for Drug Control, Czech 

Republic 

Theme 9 | Pharma e-World 

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

Standards, sanofi-aventis, France 

David Iberson-Hurst, CDISC Technical Architect, CDISC, UK 

The new pharma world of personalised and translational medicine, with its 

increasing integration of pharma R&D with healthcare, would not be possible 

without an ever increasing use of information technologies. This brings a 

number of drastic changes in processes, standards and tools, as well as the 

need to deal with the growing concerns of patients about the privacy of their 

health information. The purpose of this theme is to explore these different 

topics. 


09:00-10:30 Session 0901 

USE OF ELECTRONIC HEALTH RECORDS FOR CLINICAL RESEARCH 


Isabelle de Zegher, Worldwide Senior Director Technology Integration & Data 

Standards, PAREXEL, Belgium 

Linking healthcare and clinical research is a topic we hear a lot about but 

why do we, as an industry, want to do this, what are the challenges and how 

close is the reality? In this session we will examine three initiatives, including 

the Innovative Medicines Initiative (IMI), and explore the key questions, the 

problems and when we might see production solutions. 

A View from Europe: The IMI EHR4CR Initiative 



A Second European View: The Wellcome Trust Sintero Project 

Ed Conley, Co-PI Wellcome Trust Sintero Project, Distributed Collaborative 

Computing Research Group, Cardiff University School of Computer Science 

and Informatics, Severnside Alliance for Translational Research (SARTRE), 

Cardiff & Bristol University Schools of Medicine, Cardiff University, UK 

A View from the US: The CDISC healthcare link initiative 

Landen Bain, CDISC Liaison with Healthcare, USA 

11:00-12:30 Session 0902 

NEW APPROACHES TO PHARMACOVIGILANCE WHEN EMPLOYING 

ELECTRONIC HEALTH RECORDS (EHRS) 


Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk 

Management, European Medicines Agency, EU 

Optimising Adverse Event Reporting with the Electronic Health Record 

Marsha Laird, Senior Strategic Analyst, Cerner Corporation, USA 

EHR-Driven Safety Surveillance: The death of individual case safety 

reporting? 

Ambrish Mathur, Vice President, Strategic Development, Aris Global, USA

32 

THEME 9 


14:00-15:30 Session 0903 

COMPARING EPRO TECHNOLOGIES: WHAT WORKS? 


Ingrid Klingmann, Managing Director, Pharmaplex bvba, Belgium 

Web-Based Assessments: The internet is an emerging modality in Patient 

Reported Outcomes 

Brian Tiplady, Senior Clinical Scientist, invivodata, UK 

A Scientific Comparison of Mobile Data Capture Technologies Being Used 

in Clinical Trials: Tablet PC, Keyboard, Personal Digital Assistant and Digital 

Pen 

Ronald Boldt, Lecturer for Process-Oriented IT-Management at HTW-Berlin / 

Managing Director, Allpen GmbH, Germany 

16:00-17:30 Session 0904 

DATA PRIVACY IN THE PHARMA E-WORLD 




In recent years medical research and pharmacovigilance have come under 

the spotlight of several Privacy and Personal Data Protection Authorities. 

Spectacular lawcourt decisions have raised public attention and new guidances 

have been issued by several countries that challenge the way we currently 

run research and drug safety. In this session, we will be addressing these new 

challenges and providing possible strategies to face them. 

Legal Issues Raised by a Research Biobank? 

Geneviève Michaux, Of Counsel, Covington & Burling, Belgium 


09:00-10:30 Session 0905 

PRACTICAL IMPLEMENTATION OF THE CDISC STANDARDS 



Over the past decade CDISC standards became THE reference for clinical 

research data. However, their implementation can be challenging and this 

session will propose practical strategies to achieve this goal. 

Almost There: CDISC end-to-end using one standards set and one format 

Jozef Aerts, CEO, Xml4pharma, Germany 

From Protocol Design to Final Reporting: CDISC implementation 

Richard Young, Area Sales Director, Medidata Solutions Worldwide, UK 

How to Go Effectively from Data Collection in CDASH to Submission in SDTM: 

The need for an eCRF library 

Isabelle de Zegher, Worldwide Senior Director Technology Integration & Data 

Standards, PAREXEL, Belgium 

11:00-12:30 Session 0906 

USING TECHNOLOGY TO IMPROVE THE CLINICAL TRIAL PROCESS 


Liz Love, Product Manager, Perceptive Informatics, UK 

Producing Quality Data for Clinical Trials: Is full on-site monitoring the only 

answer? 

Imane Kermadi, Director, EMEA, Project Coordination Services, Kendle, UK 


14:00-15:30 Session 0707/0907 

STATISTICAL COMPUTING: PROGRESS IN COMPUTATIONAL SCIENCE IN 

CLINICAL TRIALS (JOINT WITH THEME 7) 


Joachim Vollmar, Executive Consultant, International Clinical Development 

Consultants LLC, USA 

One of the most important and unrecognised issues contributing to drug 

development time and regulatory quality is the ability to acquire, store, 

analyse, share and report information needed to make the most informed and 

rapid decisions in pharmaceutical companies, contract research organisations, 

and international regulatory agencies. This session will review the current state 

of data standards, and analytical/graphical tool development, as well as user 

experiences and expectations 

FDA’s Computational Sciences Initiative: Goals and current state of 

implementation 


Dynamic and Interactive Tools 

Michael O’Connell, Director, Life Sciences, TIBCO, USA 

Graphics 

Fabrice Bancken, Expert in Quantitative Safety, 

Switzerland 

Novartis Pharma AG, 

16:00-17:30 Session 0908 

CLINICAL TRIAL TECHNOLOGIES AND THE SITE: WHERE NEXT? 


Maurizio Rainisio, Vice President, Head of Global Biometry, Actelion 

Pharmaceuticals Ltd., Italy 

Simplicity (for sites) is the Ultimate Sophistication 

Keith W. Wenzel, Senior Product Director, eClinical, Perceptive Informatics, 

USA 

EDC Achieved: What new challenges did it reveal and what’s next? 

Simon Brooks, Vice president, Data and Product Integration, Phase Forward, 

UK

THEME 10 

33 


Theme 10 | CMC, Inspection and Assessment, Quality 

and Counterfeiting 

Georges France, Vice President Quality Strategy, Global Quality Operation, 

Pfizer, UK 

Jean-Louis Robert, Head, Department of Medicines Control Laboratory, 

National Health Laboratory, Luxembourg 

This theme will address several different areas concerning the pharmaceutical 

quality of medicines. The latest developments in the new quality paradigm 

described by ICH Q8, Q9 and Q10, for drug substance and drug product will 

be discussed, focusing on the practical aspects and including the role of the 

pharmacopoeia. Opportunities available to the MA holder from combining good 

pharmaceutical development and quality risk management with an efficient 

quality system will be considered (e.g. post-approval change management 

protocols and the Variations Regulation). The theme will also explore the 

impact on quality and counterfeiting challenge arising from globalisation of 

pharmaceutical manufacturing and supply chains, and the recent European 

legislation concerning the development of paediatric medicines. Finally there 

will be an opportunity for participants to bring their own topics to the forum 

for debate. 


09:00-10:30 Session 1001 

THE DEVELOPMENT OF PHARMACEUTICAL PRODUCTS IN THE CONTEXT OF 

THE NEW QUALITY PARADIGM 


Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National 

Health Laboratory, Luxembourg 

This session will cover the latest developments in the New Quality Paradigm 

impacting the development of drug substances (small molecule and biotech), 

drug products and how it can facilitate the implementation of new technologies. 

Molecules of Chemical Origin in the New Paradigm 

Keith McDonald, Assessment Team Manager, Licensing Division, MHRA, UK 

Biotech in the New Paradigm 

Brian Withers, Director, CMC Global Pharmaceutical Regulatory Affairs, Abbott 

Laboratories, UK 

Development of New Technology and their Acceptance by Regulators 

Alastair Coupe, Senior Director, Pharmaceutical Sciences, Pfizer Global R&D, UK 

11:00-12:30 Session 1002 

NEW PARADIGM, LATEST DEVELOPMENT (2): INTERACTION AND 

IMPLEMENTATION OF ICH Q8, Q9 AND Q10 


Georges France, Vice President Quality Strategy, Global Quality Operation, Pfizer, 


This session will address the achievements of the ICH IWG to achieve consistent, 

harmonised implementation of Q8, Q9 and Q10, and consider the interaction of 

these guidelines with the practical implementation of the quality system and 

new approaches for process validation. 

An Update on Progress and Achievements of IWG Q8, Q9, Q10 

Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National 

Health Laboratory, Luxembourg 

Quality Systems Following Q10 Principles: Myth or reality? 

Nigel Hamilton, Quality Director, Sanofi Aventis, France 

Process Validation in the New Quality Paradigm 



14:00-15:30 Session 1003 

VARIATION REGULATION: POST-APPROVAL CHANGE MANAGEMENT 

PROTOCOL 


Keith Pugh, Expert Pharmaceutical Assessor, MHRA, UK 

A new variations system was introduced on 1 January 2010 (EC/1234/2008). 

The accompanying classification guideline introduces the concept of a 

post-approval change management protocol and addresses how updates in 

association with agreed protocols will be managed. The protocol is intended 

to help facilitate the management of post-approval changes to the quality 

aspects of the dossier, relating to both the active substance and finished 

product and is not restricted to variations. The session will clarify the principles 

and procedures related to this new concept as well as reflecting on the 

potential benefits in terms of simplification and flexibility and any experience 

to date. 

Post-Approval Change Management Protocols – a regulatory perspective 

Keith Pugh, Expert Pharmaceutical Assessor, MHRA, UK 

Post-Approval Change Management Protocols - Industry perspective for 

small molecules 


Post-Approval Change Management Protocols - Industry perspective for 

biological products 


16:00-17:30 Session 1004 

IS THERE A NEED FOR A PHARMACOPOEIA IN THE NEW QUALITY 

PARADIGM? 


Susanne Keitel, Director, European Directorate for the Quality of Medicines 

and Healthcare (EDQM), EU 

The “new quality paradigm” outlined in ICH guidelines Q8, Q9 and Q10 

offers additional flexibility to companies, e.g. in defining a design space and 

their control strategy, based on sound and in-depth development studies. 

The session will discuss the implications this new paradigm has on the 

pharmacopoeia – a compilation of legally binding quality standards - and 

will provide the viewpoint of EU regulators, the innovative and the generic 

industry and the pharmacopoeia on the future role of the pharmacopoeia in 

this new environment. 

A Regulator’s Expectations of the Pharmacopoeia in the New Quality 

Paradigm 

Keith McDonald, Assessment Team Manager, Licensing Division, MHRA, UK 

How can the Pharmacopoeia Fulfil the Innovator’s Needs in the New Quality 

Paradigm? 

Graham Cook, Senior Director, Global Quality Operations, Pfizer, UK

34 



The Role of the Pharmacopoeia in the New Quality Paradigm 

Susanne Keitel, Director, European Directorate for the Quality of Medicines and 

Healthcare (EDQM), EU 


09:00-10:30 Session 1005 

GLOBALISATION OF MEDICINE (1): IMPACT ON QUALITY 


Jacques Morenas, Deputy Director, AFSSAPS, France 

Stephan Roenninger, Global Quality Manager, F. Hoffmann-La Roche AG, 

Switzerland 


11:00-12:30 Session 1006 

GLOBALISATION OF MEDICINE (2): COUNTERFEITING ASPECTS 


Thierry Bourquin, Vice President, Global Quality, Sanofi-Winthrop Industrie, 

France 


14:00-15:30 Session 1007 

PAEDIATRIC FORMULATIONS 


Diana van Riet, Coordinator, Regulatory Affairs, National Institute for Public 

Health and the Environment, The Netherlands 

This session is dedicated to the coming EU guideline on the pharmaceutical 

development of medicines for paediatric use. The session will provide an indepth 

review of the current approaches towards fundamental aspects as the 

selection of the dosage form, the safety of excipients and patient acceptance, 

both from a European, WHO and US perspective. It will also update the 

audience on the latest achievements towards these aspects as achieved by 

EUPFI, a consortium of EU industry and academia. 

The European Quality Guideline on Paediatric Formulations 

Diana van Riet, Coordinator, Regulatory Affairs, National Institute for Public 

Health and the Environment, The Netherlands 

A Global Perspective on the Pharmaceutical Development of Paediatric 

Medicines 

Emma Du Four, Director, Regulatory Policy & Intelligence, Abbott Laboratories, 


Fostering Knowledge on Paediatric Formulation Development: An update 

from EUPFI 


16:00-17:30 Session 1008 

WHAT’S NEW IN QUALITY? (WITH QUESTIONS FROM THE AUDIENCE) 




This session will provide an update of the key quality initiatives in EU, and 

will reflect the higher priority topics and activities of both the CHMP Quality 

Working Party and the EFPIA Technical Development Operations Committee. 

The following topics are foreseen, but may be revised due to future 

developments: 

• process validation/continuous verification 

• real time release testing 

• quality of investigational medicinal products 

• genotoxic Impurities 

• impact of implementing ICH Q8, Q9 and Q10 on existing guidelines e.g. 

specifications 

• innovative technologies 

• topics to be proposed by participants. 

This will be a joint presentation, providing both an industry and EU regulatory 

agency perspective. It is envisaged that this will be an interactive session, 

and audience participation will be actively encouraged. Additional topics 

from the delegates can be proposed prior to the session. 

EU Regulator’s Point of View 

Jean-Louis Robert, Head, Department of Medicines Control Laboratory, 

National Health Laboratory, Luxembourg 

Industry Point of View 



Theme 11 | The Drug/Device Boundary: Is it about to 

disappear? 

Michael Hotze, Director, Head of Clinical Research, Institut Straumann AG, 

Switzerland 

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

Communication Ltd., Switzerland 

The European regulatory requirements for marketing medical devices are 

fundamentally different from those for medicinal products. In Europe, the 

new approach underpins the medical devices requirements, meaning the 

manufacturer takes full responsibility for bringing medtech products to 

market. This is in contrast with the medicinal product regulations, where the 

competent authority takes responsibility for approving, and thus allowing, a 

medicinal product to be marketed. 

In areas where medicinal products and medical devices are used in combination, 

the respective regulations of both have already been adapted to address these 

products. In addition, more lately, the product documentation requirements for 

medical devices has been increased: for example, the revision of the Medical 

Device Directive (MDD), which came into force on March 21, 2010, demands 

more from manufacturers in terms of both the quality and quantity of clinical 

data. In this track, an overview of the medical device regulations will be given 

and differences between these and the pharma requirements highlighted. It 

will also focus on particular topics in the medical device area. 

Additional sessions will then address the special situations that arise with 

medicinal product and medical device combination products, and in vitro 

diagnostics.

THEME 11 

35 



09:00-10:30 Session 1101 

KEYNOTE INTRODUCTORY SPEECHES SETTING THE SCENE 



Communication, Switzerland 

In this session keynote speakers from the European Commission, and the 

device and drug industries will share their views on the pros and cons of the 

current European legislation for medical devices and drugs. An update on the 

ongoing recast of the Medical Device Directives will be provided, and the issue 

of whether changes are needed to the drug and device laws will be discussed. 

To What Extent does DG Sanco Anticipate any Elements of Convergence 

between Drug and Device Regulations in future, and its Reasoning? 


The Medical Device Industry View on Drug and Device Regulations Converging 

Toni K. Jørgensen, Senior Vice President Corporate Regulatory Affairs, Institut 

Straumann AG, Switzerland 

The Pharma Industry View on Drug and Device Regulations Converging 

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

Switzerland 

11:00-12:30 Session 1102 

BORDERLINE PRODUCTS AND IMPACT ON DEVELOPMENT 


Geneviève Michaux, Of Counsel, Covington & Burling, Belgium 

Borderline becomes Border Area 

Erik Vollebregt, Attorney, Greenberg Traurig, The Netherlands 

Medicine – Medical Device Borderline Situations 

David Van Passel, Senior Legal Counsel, Johnson and Johnson, The Netherlands 

Medicine or Medical Device: What legal consequences? 

Heike Wachenhausen, Head Legal and Regulatory Affairs, Novartis Pharma 


14:00-15:30 Session 1103 

REGULATORY FRAMEWORK FOR COMBINATION PRODUCTS 


Michael Hotze, Director, Head of Clinical Research, Institut Straumann AG, 

Switzerland 

In this session speakers from industry, a Notified Body and an independent 

expert will give an overview of the legal framework and the consultation 

process of the regulatory pathways for registration of drug-device combination 

products in the US and Europe. In a case study it will be presented how a 

combination product has been registered globally. 

Overview of Legal Framework for Combination Products in the EU and the US 


Communication, Switzerland 

Consultation Process for Combination Products 

Gert Bos, Head of Regulatory and Clinical Affairs, BSI, UK 

Case Study about Global Regulatory Pathway for Registration of a 

Combination Product 

Erika Johnson-Froneberg, Senior Manager Global Regulatory Affairs, Baxter 

BioScience, Austria 

16:00-17:30 Session 0104/1104 

IN VITRO DIAGNOSTIC (JOINT WITH THEME 1) 



Switzerland 

Case Study: Development of an IVD 

Stephen Little, Vice President, Personalised Healthcare, Qiagen, UK 

Point of Care Testing in Clinical Trials 

Michael Wickham, Managing Director, Woodley Equipment Company Ltd., UK 

Case Study of Regulatory Process of Registration of In Vitro Diagnostic with 

a Medicinal Product 


Switzerland 


09:00-10:30 Session 1105 

POINTS TO CONSIDER IN CLINICAL DEVELOPMENT OF COMBINATION 

PRODUCTS 


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

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

Netherlands 

Clinical Design of a Combination Product 

Edith Hantak, Director Clinical Development, Baxter Innovations GmbH, Austria 

Effective Planning of Medical Device vs. Drug Clinical Studies: Key 

Considerations 

Molly Blake-Michaels, Director, Clinical Services, ClearTrial, LLC, USA 

Insights from FDA International GCP Inspections of Device and Device-Drug 

Combination Products: Case studies for building high-quality data 

Lester Jao Lacorte, FDA Medical Officer, Commissioner’s Fellow, FDA, USA 

11:00-12:30 Session 1106 

THE DEVELOPMENT OF MEDICAL DEVICES 



This session will have an introduction to the work of the Global Harmonisation 

Task Force and the International Conference on Harmonisation, an overview 

of the device development process and a summary of how to combine device 

vigilance and pharmacovigilance responsibilities within one company. 

Introduction to the Global Harmonisation Task Force and Comparison with 

the International Conference on Harmonisation (ICH) 


The Development Process for Medical Devices 

Neil R. Armstrong, CEO, MeddiQuest Limited, UK

36 

THEME 12 


Quality System Requirements for a Medical Device Company 

Dirk Wetzel, Head of the Medical Devices Division, BfArM, Germany 

14:00-15:30 Session 1107 

CLINICAL DEVELOPMENT OF MEDICAL DEVICES 


Danielle Giroud, Founder, World Medical Device Organisation, Switzerland 

Clinical Aspects of EU Medical Device Directives MDD 93/42/EEC and 

2007/47/EC 

Danielle Giroud, Founder, World Medical Device Organisation, Switzerland 

Navigating ICH E6 GCP or ISO 14155 for your Combination Product 

Matthew J. Tarosky, Deputy Director, Division of Bioresearch Monitoring, Office 

of Compliance 

FDA, USA 

Notified Body Expectations for Clinical Evaluation of Medical Devices 

Christian Schübel, TüV Süd Product Service GmbH, Germany 

Theme 12 | Drug Development in the Real World 

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

PharmaNet B.V., The Netherlands 

Ineke Rijnhout, Consultant, Kenko International, The Netherlands 

This theme will address current issues in global drug development that face 

innovators and licensees. Have the recent changes in the industry structure 

with recent mergers and divestment of unwanted drug portfolios had an effect 

on strategies adopted to get products to market? Moreover, new regulatory 

challenges and revisions require not only compliance with requirements 

but also long term post marketing commitments and demand innovative 

approaches to the global approval process. Achieving quality and effective 

clinical study conduct determines product competitiveness. Tactics to improve 

operational achievements, partnering with service providers and the utilisation 

of emerging territories to recruit sufficient patients on time will be discussed. 

The increasing influence of patients or patient organisations in clinical research 

is a phenomenon that will be addressed. 


09:00-10:30 Session 1201 

EFFECTIVE GLOBAL CLINICAL DEVELOPMENT: FUTURE TRENDS 




This session focuses on some of the current drivers for drug development 

including the economics of the pharmaceutical industry and clinical disease 

state modelling. Techniques used to derive information on the most 

appropriate strategy for conducting clinical research such as data mining 

techniques will be covered to indicate some of the more innovative techniques 

to ensure clinical development success. 

Economic Trends in the Pharma Industry: Drivers of medicines development 


Clinical Disease State Modelling: Personalised Medicine 

Michael N. Liebman, President/Managing Director, Strategic Medicine, Inc. USA 

Analysing Contemporary Clinical Trial Activity and Matching with Global 

Trends: The value of data mining 

David Cocker, MDC Partners, Belgium 

11:00-12:30 Session 1202 

COST REDUCTION STRATEGIES IN CLINICAL TRIAL CONDUCT 


Nermeen Varawalla, President & CEO, ECCRO, UK 

The imperative to contain the costs of clinical trial conduct is more than ever 

before. Eliminating the inefficiencies in stakeholder liaison could universally 

save costs. Best practices in managing CROs, study planning and setting up 

contracts with clinical trial sites will be shared followed by a discussion of the 

implementation of these practices. 

Cost Reduction during the CRO/Sponsor Interface 

Rikke Winther, Divisional Director, Outsourcing Management, H. Lundbeck 

A/S, Denmark 

Reducing Clinical Trial Costs while Maintaining Study achievability: 

Case studies 

Melinda Davis, Director, Clinical Services, Clear Trial, USA 

The Impact of Legal and Contract Process on Clinical Trial Costs and 

Efficiencies 

Myrthe Rijswijk-Trompert, Independent Consultant, The Netherlands 

14:00-15:30 Session 1203 

POST-APPROVAL STRATEGIES 


Jens Reinhold, Head GMA-NIS, Bayer Schering Pharma AG, Germany 

This session will focus on strategies to maintain product lifecycle and focus 

on the importance of post-approval research and strategies to ensure rapid 

approvals to maximise effective patent life on a global basis. 

When to Start Thinking about Peri-Approval Strategies 

Jens Reinhold, Head GMA-NIS, Bayer Schering Pharma AG, Germany 

Develop Globally - Like it or not 

Nancy Meyerson Hess, Director of Business Development, Harrison Clinical 

Research, Germany 

Post -Approval Strategies and Changes to Reduce Lead Time for Worldwide 

Approvals 

Lone Eskilden, Manager, Novo Nordisk A/S, Denmark 

16:00-17:30 Session 1204 

PATIENTS: AN INCREASINGLY INFLUENTIAL VOICE IN DRUG 

DEVELOPMENT 




Patients are important participants in clinical studies and are endpoint users 

of marketed products with unique expectations. Their voice in how clinical 

research should be conducted, from their perspective as trial participants, is 

important and their needs and expectations should be addressed in terms 

of good clinical practice and setting priorities for medicines development 

but also in the provision of information on marketed products. Additionally, 

guardians of vulnerable patient populations such as the elderly and paediatric


37 


subjects are instrumental to the success of clinical research and should be 

active partners in the drug development process. 

Enlightened Patient: Pharma customer expectations in the 2010s 

Juha-Matti Saario, SOP Governance Officer, Novartis Pharma AG, Switzerland 

Moving Beyond the Agency Interaction: Involving patients in drug 

development 

Anders Blaedel Lassen, Reg. Int. & Pol. Specialist, H. Lundbeck, Denmark 



09:00-10:30 Session 1205 

PARTNERING IN DRUG DEVELOPMENT 


Ineke Rijnhout, Consultant, Kenko International, The Netherlands 

Nearly half of today’s top-selling drugs in the pharmaceutical industry are the 

result of partnerships. The pressure to maintain strong portfolios underscores 

the importance of alliance management. Last year, in the depths of the financial 

crisis, many companies took drastic restructuring measures, bringing focus 

and creativity to the efficiency-related challenges. The key driver for survival is 

their ability to find ways to operate drug development more effectively. What 

creative partnering structures approaches are companies using in today’s 

challenging times? 

A New Model for Developing CRO Partnership: Project Nemo 

Frederic Monnot, Clinical Research Manager, Merck Serono, Switzerland 

CRO Pharma Partnership Example 


Biotech/Pharma Partnering 


14:00-15:30 Session 1207 

HEALTH ORGANISATIONS AND THEIR INFLUENCE ON DRUG DEVELOPMENT 


Richard Laing, Team Leader, Medicine Information and Evidence for Policy, 

Department of Essential Medicines and Pharmaceutical Policies, WHO, 

Switzerland 

Health Organisations play an important role in identifying the health needs 

of the global population and are instrumental in defining development 

strategies and access to safe medicines. One such organisation is the WHO. 

Other important areas are neglected diseases and orphan indications, where 

financial considerations and the logistical aspects of conducting clinical 

research in these populations may be important hurdles and play an important 

role in setting development priorities. The emergence of herbal medicines as 

a therapeutic intervention is increasing and the appropriate regulation of their 

manufacture and clinical development will be discussed. 

The Role of the WHO in Setting Drug Priorities 


Neglected Disease and Orphan Medicines 

Johan Frieling, Independent Consultant, The Netherlands 

The Importance of Herbal Medicines as a Therapeutic Class - How to conduct 

clinical research and regulate their development 


16:00-17:30 Session 1208 

INVESTIGATOR-LED CLINICAL DRUG DEVELOPMENT 


Xavier Carné, Head of Clinical Pharmacology Department, Hospital Clinic, 

University of Barcelona School of Medicine, Spain 

Prior to the introduction of the European Clinical Trial Directive, investigator 

led clinical development played a prominent role in medicines development. 

In some settings this is still the case and academic sites regain their influence 

on defining priorities for medicines based on the latest scientific advances. 

Speaker from academia and investigator networks will address the challenges 

ensuring that data generated from investigator led research is of the highest 

quality and is appropriate to support drug registration. 

Investigator-Led Research: Experience of the Medicines for Children 

Reasearch Network 

Nicholas Webb, Royal Manchester Children’s Hospital, UK 

Investigator Initiated Trials (IIT) – State of the industry and the need for 

global standards and metrics 

Ran Frenkel, CEO, Pharma Focus, Israel 

Theme 13 | Biologicals and Vaccines – Access to 

Innovation 

Thomas Verstraeten, Head Biologicals Clinical Safety & Pharmacovigilance, 

GlaxoSmithKline Biologicals, Belgium 

Michael Pfleiderer, Head of Section, Viral Vaccines, Paul-Erhlich-Institut (PEI), 

Germany 

This theme will focus on a number of areas specific to biologicals and vaccines. 

As well as looking to see what impact recent changes to the EU legislation have 

had, this theme will provide time to discuss and share new developments and 

advances that have and will be seen in the area of biologicals and vaccines. And 

finally, perhaps a slight departure from the other topics under this theme, there 

will be a session to allow reflection on the public perception of medicine and 

in particular the public perception of vaccines and vaccination programmes. 


09:00-10:30 Session 1301 

PHARMACOVIGILANCE FOR BIOLOGICALS AND VACCINES 


Phil Bryan, Expert Scientific Assessor, MHRA, UK 

This session will outline recent examples of potential quality issues for 

authorised vaccines, describe the systems in place to identify and evaluate 

the potential clinical implications and risks and to discuss processes for 

traceability, recall and implications for immunisation programmes. It will also 

aim to explore ways in which systems and processes can be improved to 

optimise risk management of vaccines in this context.

38 

THEME 13 


Regulator’s Perspective 

Brigitte Keller-Stanislawski, Head, Pharmacovigilance, Paul-Ehrlich-Institut 

(PEI), Germany 

Public Health Perspective 

Professor David Salisbury, Department of Health, UK 

OMCL Perspective 


11:00-12:30 Session 1302 

HAS THE NEW EU VARIATIONS REGULATION MET ITS OBJECTIVE OF 

OPTIMISING, SIMPLIFYING AND RATIONALISING THE REGULATORY 

PROCESSES FOR BIOLOGICALS AND VACCINES? REVIEW OF SPECIFIC 

EXPERIENCES TO-DATE 


Stephane Callewaert, Senior Manager, Regulatory Policy, Worldwide Vaccine 

Registration, GlaxoSmithKline Biologicals, Belgium 

The new EU Variations Regulation has been driven by the European 

Commission better regulation initiative, aiming at optimising, simplifying 

and rationalising the regulatory processes. This session will aim at reviewing/ 

assessing specific experiences to-date of biological products with the key new 

features introduced. 

• How helpful is the new variation classification for biologicals? (Type IA “Do 

and Tell”, Type IB by default, ...). Are there less Type II for biologicals? 

• Is the Art.5 recommendation process being used? How is it working so far? 

Is there a mindset evolution towards biologicals and vaccines? 

• Review of experiences of grouping and worksharing. How practical are 

these new procedures? Are these applicable and helpful for variations to 

biologicals and vaccines? 

• ‘Quality by Design’ ând ‘Post-Approval Change Management Protocols’: 

How practical/applicable are such concepts for biologicals? Any 

experience(s) to date? 


14:00-15:30 Session 0603/1303 

SAFETY ASPECTS IN THE DEVELOPMENT OF VACCINES (JOINT WITH 

THEME 6) 





There is an increasing awareness that vaccines have their own characteristics 

in safety aspects. The recent introduction of adjuvants in marketed products 

has underlined this. The risk of an increase in autoimmune phenomena and the 

safe use of vaccines during pregnancy are hot topics. The WHO is giving its 

perspective on the use of adjuvants. 

WHO Perspective on Adjuvants in Vaccines 

Martin Howell Friede, Technical Officer, Initiative for Vaccine Research, WHO, 

Switzerland 

Adjuvants and the Potential Risk of Autoimmunity 

Sarah Gould, Non Clinical Safety Division, Sanofi Pasteur, France 

Vaccines and Pregnancy 




16:00-17:30 Session 1304 

SPECIFICITIES OF CLINICAL TRIALS FOR BIOLOGICALS AND VACCINES IN 

EMERGING MARKETS 




09:00-10:30 Session 1305 

PROGRESS OF NEW TECHNOLOGIES 


Bruce Weniger, Associate Editor, Vaccine, Retired/Guest Researcher, U.S. 

Centers for Disease Control and Prevention , USA 

Novel methods in antigen discovery, synthesis, carriage, adjuvantation, and 

delivery are energising the vaccine segment of the pharmaceutical industry, 

often with application to mainstream pharmaceuticals. This session will 

highlight a few of these, including the critical issue of evaluating their safety. 

Included will be techniques for identifying improved antigens, a regulatory 

perspective on nanoparticles, new adjuvants to boost the immune response, 

and needle-free methods for safer, simpler, swifter vaccination. 

New Antigen Discovery 


Evaluating the Safety of Nanotechnology for Biologicals 

Marisa Papaluca-Amati, Deputy Head of Sector, Sector Clinical Safety and 

Efficacy, European Medicines Agency, EU 

Progress in New Adjuvants/Immunopotentiators 

Natahlie Garcon, Vice President and Head Global Adjuvants and Alternative 

Delivery Centre, GlaxoSmithKline Biologicals, Belgium 

Update on Novel Delivery Technologies for Vaccines 

Bruce Weniger, Former Lead, Vaccine Technology at Centers for Disease 

Control and Prevention, USA 

11:00-12:30 Session 1306 

EUROPE’S ROLE IN SUPPORTING THE REGULATION OF BIOLOGICALS AND 

VACCINES OUTSIDE EUROPE 


Pieter Neels, Co-Chair, Vaccines Working Party, CHMP member for Federal 

Agency for Medicinal and Health Products, Belgium 

European Medicines Agency View 

Marie-Helene Pinheiro, Scientific Administrator, Regulatory Affairs, European 



14:00-15:30 Session 0807/1307 

HOW SHOULD THE PAEDIATRIC SCHEME BE AMENDED AND WHY? (JOINT 

WITH THEME 8) 


Angelika Joos, Director, Head Regulatory Policy, EU & Most of World, Merck 


The introduction of the Paediatric Regulation was celebrated as important 

public health milestone in 2006. Its implementation required a significant 

change in the drug development process and a mindset shift. Experience


39 


from industry during the first 3 years of operating under the new scheme 

will be presented. Concrete changes to current instruments will be suggested 

to address potential identified short comings in order to ensure that the 

Regulations’ objectives are effectively met. Reactions and perspectives from 

policy makers and regulators will complement the picture. 

Industry View of Paediatric Regulation Impact 

Ali Harrison, AstraZeneca, UK 

What changes would we need to address the findings? 

Genevieve Michaux, of Counsel, Covington and Burling, Belgium 

Does this Outcome Meet the political Vision? 


Panel with Agnès Saint-Raymond, Head of Human Medicines Special Areas, 


16:00-17:30 Session 1308 

GLOBAL ACCESS TO VACCINES 



The explosion of vaccine development in recent years is impressive. However, 

as with all medicinal products, there needs to be mechanisms in place to 

ensure global access to these vaccines. Various groups have a number of 

different initiatives underway to try and achieve this. During this session we 

will hear from these groups about their current and future initiatives. 


Theme 14 | Knowledge Management and Telematics: 

Enhancing exchange between industry and regulators 

and improving support for their decision-making 

Andrew P. Marr, Director, Global eRegulatory Development, Global 

Regulatory Operations, GlaxoSmithKline, UK 


Agency, EU 

It is evident that data and information, if well-managed, have value and are 

worth investment. From these elements come knowledge and knowledge 

underpins timely and informed decisions. Data and information can only be 

transferred, communicated and managed well through the application of 

standards, technologies and carefully considered and optimised processes. 

Such a disciplined knowledge-based approach to the development of medical 

therapies can lead to better decisions within the industry and by its regulators. 

In turn this leads to evidence-based decisions from informed healthcare 

practitioners for the benefit of their patients. 

The theme will tackle two major challenges. Firstly it will address the strategic 

direction within the regulatory and regulated communities and the impact of 

changes in the legislation and guidance. The implementation of the regulatory 

EU Telematics Strategy and its application within pharmaceutical industry will 

be explored through the practical examination of standards, safety analysis and 

electronic submissions including those for product information. Case studies 

will contribute powerfully to a detailed understanding of the issues involved. 

Secondly, the theme will explore the implementation of good knowledge 

management practices, both in terms of behaviours and technology. Through 

the value added by standards, technology and processes, effective data, 

information and knowledge transfer between organisations can be enhanced, 

ensuring reliability, accuracy, reproducibility, completeness, traceability, 

timeliness and most importantly, that it is fit for purpose for all stakeholders. 


09:00-10:30 Session 1401 

STANDARDISATION: HOW IT REALLY HELPS 


Geoff Williams, e-Regulatory Liaison, Regulatory Operations, Roche Products, 


The effort to create global standards has been recognised as a key component 

in allowing industry and regulatory authorities to work more efficiently. 

Standards to support work in pharmaceutical development are being 

developed at global, regional and national levels. After a brief introduction to 

set the scene, this session will provide information about three standardisation 

projects and how they will help support the goals of industry and regulators. 

Individual Case Safety Reports (ISCR): Progress on the development of the 

new ISO standard 

Anja van Haren, EurdraVigilance Coordinator, Medicines Evaluation Board 


Identification of Medicinal Products (IDMP): Progress on the development of 

the ISO standard 

Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk 

Management, European Medicines Agency, EU 

CDISC SHARE – Sharing a better understanding of clinical data 


11:00-12:30 Session 1402 

PRODUCT INFORMATION MANAGEMENT (PIM): IN PRODUCTION – 

MIGRATION DEADLINE APPROACHING 



Agency, EU 


14:00-15:30 Session 1403 

BEST PRACTICE IN ELECTRONIC INFORMATION EXCHANGE FOR 

REGULATORY SUBMISSIONS 


Remco Munnik, Regulatory Affairs Information Manager, Sandoz B.V., The 

Netherlands 

Harmonisation Efforts in Connection with Recent EU Renewals to Prepare 

for Product Information Management (PIM), Improve Readability and 

Consistency across a Product Family 

Maja Nordholm, Regulatory Professional, Novo Nordisk A/S, Denmark 

16:00-17:30 Session 1404 

STRATEGIC DIRECTIONS IN INFORMATION TECHNOLOGY ACROSS THE 

MEDICINES NETWORK 


Katy Page, Senior Director, Worldwide Regulatory Operations, Pfizer, UK 

This session will offer several perspectives on the strategic direction for 

telematics related to electronic submissions and exchange of information 

across the Medicines Network. An industry overview of US priorities will 

be followed by a regulator perspective on the status of convergence of 

technology and approach across Europe. It will conclude with an explanation 

of the future e-submission standard Regulated Product Standards (RPS), and

40 

THEME 14 


how this evolution aligns with US and European strategy. 

Strategic Directions in the US: An industry perspective 

John Kiser, Senior Director, Global Submission Operations & Business Strategy, 

Global Pharmaceutical Regulatory Affairs, Abbott Laboratories, USA 

‘E’ Strategy & the European Submissions Platform: A regulator perspective 


Regulated Product Standards and Alignment with European Strategy 

Geoff Williams, E-Regulatory Liaison, Roche Products Ltd, UK 


09:00-10:30 Session 0205/1405 

IMPLEMENTATION OF THE REVISED VARIATIONS REGULATION – ARE THE 

OBJECTIVES BEING MET? (JOINT WITH THEME 2) 




The revised Variations Regulation (EC No. 1234/2008) applied from 1st January 

2010 to marketed authorisations granted through a mutual recognition process, 

decentralised procedure or centralised procedure. The overall objectives of 

this revision were to provide a simpler, clearer and more flexible legislative 

framework governing variations. 

Based on 15 months experience, industry and regulatory experts will 

provide a perspective on whether these objectives are being met. Specific 

considerations will be given to experience on procedural aspects, managing 

CMC changes, and implications for e-Submissions. 

The Revised Variations Regulation - Are the new ideas at life? 

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

Germany 

Implementation of the Updated EU Variation Regulation – Simpler, clearer 

and more flexible? 

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

Denmark 

Challenges and Opportunities for E-submissions 

Remco Munnik, Regulatory Affairs Information Manager, Sandoz, B.V., The 

Netherlands 

11:00-12:30 Session 1406 

KNOWLEDGE MANAGEMENT: CULTURES, BEHAVIOURS AND 

ORGANISATIONS 


Raun S. Kupiec, Senior Director, Regulatory Affairs, Genzyme Europe, The 

Netherlands 

New standards, technology solutions and process initiatives are everywhere in 

pharma and the health sector. These initiatives promise to fundamentally alter 

the way we do business, improving quality and efficiency. 

However, dramatic initiatives and fundamental changes are nothing new 

(remember the paperless office that was around the corner 20 years ago?). 

How far have we come, where are we going, and what are the day-to-day 

implications for how we work in the organisational framework of drug 

development? 

Clinical Trial Registries – Where do we stand? 

Susanne Jena, Project manager, University Medical Center Freiburg, Germany 

Clinical Documentation Made Easy: Managing our eTMF using the DIA 

reference model 

Jascha Minow, Product Manager, Nextdocs Corporation, Germany 

System Validation: Is it fit for purpose? 


14:00-15:30 Session 1407 

SIGNAL DETECTION – MAKING USE OF AVAILABLE DATA SOURCES 


Wayne Kubick, Vice President, Phase Forward Lincoln Safety Group, USA 

This session will explain and explore the use of signal detection methods to 

improve the management of lifecycle product safety. The session will begin 

with a brief description of signal detection methods, and comprise case studies 

that discuss signal detection, management and evaluation using spontaneous 

report and observational data from the perspectives of a sponsor, regulatory 

authority and academic research organisation. 

Implementing Signal Detection Methodology in a Medium-Sized Company: 

Case studies review 

William Smedley, Director, PV Operations, Shire Pharmaceuticals, USA 

Signal Detection and Management from a Regulatory Perspective 



Signal Generation and Evaluation in Health Care Data – A case study using 

German claims data 

Marc Suling, Research Scientist, University of Bremen, Bremen Institute for 

Prevention Research and Social Medicine (BIPS), Germany 

16:00-17:30 Session 1408 

KNOWLEDGE MANAGEMENT: TECHNOLOGIES 



In the new global, IT-based knowledge economy, the possession of relevant and 

strategic knowledge and its unceasing renewal is fundamental for businesses 

to remain competitive. This session will provide real-world examples of 

companies successfully tackling this challenge as well as providing a glimpse 

into how state-of-the-art cloud computing might transform knowledge 

management in Clinical R&D. 

Using Social Media to Support Knowledge Sharing and Obtain Cost Savings 

- From strategy to action by understanding the users 

Erik Korsvik Ostergard, Principal Consultant, Manager, Novo Nordisk S/A, 

Denmark 

Knowledge Management Enablers - Operational and quality control centres 

Siegfried Schmitt, Principal Consultant, PAREXEL, UK 

Cloud Computing in Clinical Research & Development – Hype or opportunity? 

David A. Medina, Director, Worldwide Life Science & Pharma Segment 

Executive, Hewlett Packard Company, USA

THEME 15 

41 


Theme 15 | Pharmaceutical Development: Regional 

Perspectives 

Urszula Scieszko-Fic, Registration Director, Temapharm Sp. z.o.o., Poland 

Vincenzo Cannizzaro, International Regulatory Specialist, Qualitecfarma, 

Spain 

This theme will look at the opportunities within several regions of the world 

and help attendees understand what challenges these regions are facing. The 

Japanese Regulatory session which has been an extremely popular and valued 

session at the EuroMeeting for a number of years will be included in Theme 15. 


09:00-10:30 Session 1501 

REGULATION SYSTEMS IN TURKEY 


Ahmet Araman, Dean, Faculty of Pharmacy, University of Istanbul, Turkey 

As an emerging market, the regulation system in Turkey will be discussed. 

EU Regulation Compliance 

Yasemin Karabey, Department Head, EU Regulations, MOH Drug and Pharmacy 

Directorate, Turkey 

Registration Process 

Yonca Iscan, Department Head, Bioavailability/Bioequivalence, MOH Drug and 

Pharmacy Directorate, Turkey 

Pharmaceutical Industry and Country Specific Conditions 

Melek Bostanci Onol, DRA Manager, Boehringer Ingelheim Ilac Ticaret 

A.S.,Turkey 

11:00-12:30 Session 1502 

MIDDLE EAST 


Kathrin Laubacher, Team Leader Training, F. Hoffmann - La Roche AG, Switzerland 

Issues from an HA Perspective 

Laila Ghazi Jarrar, Director General, JFDA, Jordan 

Work of a CRO in the Middle East 

Vladimir Misik, Senior Regional Director, Middle East Clin Ops, Quintiles, Austria 

Experience with Regulators in the Region 

Heba Hashem, Regional Regulatory Manager, Bayer Schering Pharma, Egypt 

14:00-15:30 Session 1503 

JAPANESE REGULATORY SESSION: PMDA UPDATE - INITIATIVES AND 

CHALLENGES FOR PROMOTING GLOBAL DRUG DEVELOPMENT 


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

Japan 

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 

Hideo Utsumi, 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 

16:00-17:30 Session 1504 

AFRICA 


Jennifer Kealy, Managing Director, Cascade Clinical Consulting Ltd., France 



09:00-10:30 Session 1505 

GLOBAL SIMULTANEOUS DRUG DEVELOPMENT AND GLOBALISATION OF 

DRUG DEVELOPMENT: FOCUSING ON CHINA 


Ling Su, Senior Vice President and Head of Development Greater China, 

Novartis Pharmaceuticals Corporation, China 

Over the past few years, multinational pharmaceutical companies are 

increasingly implementing the strategy of global simultaneous drug 

development including China. At the same time, the globalisation of drug 

development activities has significantly facilitated the growth of R&D services 

in China. In this session, speakers will discuss the recent evolution of drug 

innovation, regulation, and R&D activities in China under this emerging 

environment. 

Regulatory Update 


Preclinical Development 

Kewen Jin, General Manager, Charles River Laboratories Great China Preclinical 

Services, China 

Clinical Development 


11:00-12:30 Session 1506 

EASTERN EUROPE/RUSSIA 


Urszula Scieszko-Fic, Regulatory Affairs Director, Temapharm Sp. z. o.o., 

Poland 


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

42 

THEME 15 | HOT TOPICS | STAND ALONE SESSIONS 


14:00-15:30 Session 1507 

LATIN AMERICA REGULATORY SESSION: AN UPDATE OF THE PAN 

AMERICAN NETWORK ON DRUG REGULATORY HARMONISATION 

(PANDRH) IN LATIN AMERICA - INITIATIVES AND CURRENT 

DEVELOPMENTS OF REGIONAL COUNTRIES (ARGENTINA, BRAZIL, PERU, 

MEXICO, OTHERS) ON IMPLEMENTING REGULATORY HARMONISATION 


Sergio Guerrero, Director, OCA Hospital/Monterrey Intl Research Center, 

Mexico 

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

the global pharmaceutical industry; therefore current developments have 

been developed that the region can present attractive new markets and 

potential research and developments for Latin America. In this session you 

will be provided with an update of the initiative of the Pan American Health 

Organisation related to the forum established through the Pan American 

Network on Drug Regulatory Harmonisation (PANDRH) to better understand 

the common regulatory system of the Latin American countries that will 

promote the harmonisation of the health of the region by facilitating the 

availability of safe, effective, and quality drugs, and by strengthen the 

regulatory structure in Latin America that will allow the development of 

harmonised instruments that can be applicable to all Latin America regional 

countries. 

Representatives from participating countries will present their views and 

current harmonisation developments in their respective countries. On the 

other hand, we will discuss future developments of the harmonisation process 

in other regional countries. 

16:00-17:30 Session 1508 

INDIA 


Chair invited 

Larisa Nagra Singh, General Manager and Director, Voisin Consulting Life 

Sciences, India 

Mubarak Naqvi, CRU Director, sanofi-aventis, India 

Hot Topics/Stand Alone Sessions 


09:00-10:30 Session 1601 

INTERNATIONAL COOPERATION PART 1: STATUS REPORTS ON THE 

INTERNATIONAL COOPERATION AMONG REGULATORY AGENCIES – FDA, 

EUROPEAN MEDICINES AGENCY AND PMDA 


Marie Dray, President, International Regulatory Affairs Group LLC, USA 

Since 2004, Confidential Arrangements for Exchange of Information between 

the US FDA and the European Union (EU) /European Medicines Agency 

(EMA) and the Transatlantic Dialogue/Administrative Simplification initiatives 

(2008) encouraged dialogue and exchange of guidances and staff between 

these regulators. In the interest of transparency, DIA has hosted sessions on 

plans for, and implementation of formal cooperation among regulators, where 

senior executives from the FDA, EMA and, most recently, the Japanese PMDA 

have very candidly shared their experiences. This session continues this high 

level conversation with DIA’s audience about these interagency meetings and 

relationships. 

Report from the FDA 

Murray Lumpkin, Deputy Commissioner for International and Special Programs, 

FDA, USA 

Report from the European Medicines Agency 


Report from the Japanese Pharmaceutical and Medical Devices Agency 

Tatsuya Kondo, Chief Executive, Pharmaceuticals and Medical Devices Agency 

(PMDA), Japan 

11:00-12:30 Session 1602 

HEADS OF MEDICINES AGENCIES 


Kent Woods, Chief Executive, MHRA, UK 

Jean Marimbert, General Director, Afssaps, France 


Aginus Kalis, Executive Director, Medicines Evaluation Board (MEB), The 

Netherlands 

Marcus Muellner, Director, AGES PharmMed, Austria 

14:00-15:30 Session 1603 

2015 ROADMAP 



EU 

On 26 January 2010, the European Medicines Agency published a draft 

paper setting out its vision for the strategic development of the Agency 

for the five years to 2015. Building on the progress of its previous five-year 

strategy, the Road Map to 2015 charts the way forward for the Agency amid 

rapid developments in medical science and pharmaceutical research, as well 

as the continuing evolution of the European and international regulatory 

environments. With this strategy paper to guide it, the Agency will seek to 

consolidate its achievements to date and further strengthen its role as a 

guardian of human and animal health in the European Union. 



16:00-17:30 Session 1604 

INTERNATIONAL COOPERATION AMONG PART 2: 

REPORT ON INTERNATIONAL COOPERATION – FROM THE POINT OF VIEW 

OF REGULATORS ON EXCHANGE ASSIGNMENTS 

Session Chair 

Brenton James, Consultant in Strategic Regulatory Affairs in the European 

Union, UK 

Janice Soreth, MD, FDA appointment working in Office of Executive Director 

of EMA 

Hilde Boone, Liaison Official at the FDA, Office of International Programs, 


PMDA speaker invited

HOT TOPICS | STAND ALONE SESSIONS 

43 


18:00-19:30 Session 1900 

SWISS SATELLITE SESSION: COOPERATION BETWEEN SWISSMEDIC AND 

WHO 

Session Chair : 


Establishing and maintaining a well-functioning network between international 

armonization like the WHO and Regulatory Authorities is key to address public 

health issues in a globalised world. It also elaborates on the potential impact 

of cooperation between WHO and regulators to the industry. This Satellite 

Symposium looks at how WHO works with Regulators in general and in 

particular with the Swiss Agency for Therapeutic Products, Swissmedic. We 

will look at how the cooperation works, what challenges had to be addressed 

and what the outcome finally was by presenting two practical examples taken 

from the field of pharmacovigilance and counterfeit drugs. 

Introduction: How the WHO works with regulators 

Overview of Cooperation between Swissmedic and the WHO 

Real-time Pharmacovigilance: The development of Paniflow 

Counterfeit Drugs: The way forward 


09:00-12:30 Session 1605/1606 

GCP FORUM: THE CHALLENGES FOR REGULATORS AND SPONSORS WHEN 

DEALING WITH CLINICAL TRIALS IN A GLOBAL SETTING 

Session Co-Chairs: 


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


The number of clinical trials involving sites and patients outside of or in 

addition to the “traditional” Western European and North American research 

areas and submitted to drug agencies in different regions for marketing 

armonization has been increasing for a number of years. To deal with this 

challenge, the European Medicines Agency (EMA) as well as the US Food 

and Drug Administration (FDA) have started several activities to establish an 

international network of clinical trial regulators. The objectives of the network 

are to promote capacity building, information exchange and cooperation. 

EMA and FDA launched a joint initiative to collaborate on international GCP 

inspection activities, which started with an 18-month pilot phase on 1 September 

2009. The initiative appreciably contributes to a mutual understanding of the 

GCP inspection processes armoniz in the EU/EEA and US and to a sharing of 

best-practice knowledge. 

In parallel to this, strengthened collaboration between Health Authorities 

that not only leads to a more armonizat approach to inspections but also to 

a closer supervision through inspections sponsor companies embark in larger 

trials, move trial activities to “new territories” and engage in all kind of formal 

and not so formal collaborations (licensing agreements, supported trials, etc.). 

This requires a much more structured approach to quality and compliance 

that goes beyond the traditional monitoring and auditing. Quality and hence 

GCP compliance in a mega-trial, for instance, can only be ensured if the right 

checks and balances are built into the protocol design and study program as 

the result of a collaborative efforts of all stakeholders concerned. 

This session will provide an up-date of the current armonization efforts of 

Health Authorities and also insight on how a “quality by design” approach 

to clinical development can allow sponsors, investigators and regulators to 

address the current unsatisfactory outcomes of today’s approach to quality 

and compliance. 

FDA's International Collaborative Activities to Exchange Scientific, 

Regulatory and Ethical Information in the Conduct of Clinical Trials 

Cynthia Kleppinger, Medical Officer, Division of Scientific Investigations, Office 

of Compliance, CDER FDA, USA 

International Cooperation on GCP and Ethical rRquirements for Clinical Trials 

- Current EMA activities 



International Clinical Trials – Current Afssaps activities 

Pierre-Henri Bertoye, Inspectorate and Companies Associate Director, Afssaps, 

France 

Risk-Based Quality Management in Clinical Trials- A European Regulator’s 

View 


Industry / CRO delegates invited 

14:00-15:30 Session 1607 

WHO-TDR: AN UPDATE 


Juntra Karbwang Laothavorn, Clinical Coordinator, TDR, WHO, Switzerland 

Switzerland WHO-TDR has a long-standing experience in conducting trials in 

so-called diseases of poverty also referred to as neglected diseases. WHO- 

TDR has managed an impressive trial program in regions where commercial 

sponsors have rarely placed trials. This session will review how WHO-TDR 

has coped with the practical and logistic challenges of such trials and what 

measures have been and are taken to ensure patients’ safety, integrity and 

rights in very different cultural and societal contexts and also how quality and 

compliance can be ensured. One important mission of WHO TDR is capacity 

building in the regions they operate in. The SIDCER and FERCAP efforts 

leading to certification of local IRBs / IECs through structured training and 

survey programs have not only benefitted WHO clinical programs but also 

represent a significant benefit for any sponsor. Building on the success of the 

IRB / IEC certification program WHO-TDR is developing a survey program 

allowing local laboratories to partake in a quality proficiency program and to 

receive an acknowledgment thereof that tailors standard quality proficiency 

programs known in the industrialised countries such as CAP to the needs of 

these regions. 

This session will provide an overview on the achievements of a clinical research 

program in neglected therapeutic areas, what has been accomplished to ensure 

patients’ safety and deliver quality results when conducting trials in regions 

with limited exposure to GCP trials, and how these efforts can benefit also 

commercial sponsors as well as how the later could learn from this experience. 


16:00-17:30 Session 1608 

ENCEPP 


Noël Wathion, Head of Public Health Protection, European Medicines Agency, 

EU 



Session under development

44 EXHIBIT AT THE EUROMEETING 


E X H I B I T I O N 

Reach your ideal target audience at the 

EuroMeeting 2011 

Showcase your company’s product or service to over 3,000 drug development professionals from over 

50 countries at the EuroMeeting 2011 in Geneva. 

Join over 200 exhibitors to interact with professionals from the pharmaceutical and device industry, 

from academia and healthcare, regulatory agencies and patient organisations. 

Booth space is sold on a first come first served basis. The fee is € 4,550 plus 7.6% Swiss VAT (from 

1 January 2011, VAT will be charged at 8%) for a 3x3m space. Each booth space includes prefitted 

shell-scheme, standard electrical supply, one table, three chairs, coffee breaks, lunches and 

receptions, one full meeting registration (which allows access to all scientific sessions) and up to 

three exhibit booth personnel registrations. 

Sign up now to be sure of the space of your choice. Download the application form 

today at www.diahome.org/euromeeting2011 > Click on the EuroMeeting icon > 

Exhibition 

EXHIBITION 

OPENING HOURS 


12:30 - 18:00 


08:00 - 18:30 


08:00 - 16:00 

For more information on exhibition space and facilities, please contact Natacha Scholl at 

DIA Europe on +41 61 225 51 59 or email: natacha.scholl@diaeurope.org 

Exhibiting Companies as of 30 September 2010 

Across Systems GmbH 

Advanced Recruitment 

ArisGlobal 

Averion International 

AXPHARMA SAS 

BaseCon 

BioClinica 

BioStorage Technologies GmbH 

C3i Inc. 

Cardiocore 

Carefusion 

Chiltern 

Clinical Reference Laboratory 

clinIT AG 

ClinTec International 

CLS Communication 

CMIC Co., Ltd. 

Comply Services 

CoreLab Partners, Inc. 

Covance 

CRF Health 

CROM Group 

CTC Clinical Trial Consulting AG 

Datatrak International 

DIA 

DIA Patient Fellowship 

Diamond Pharma Services 

eClinica 

ECLINSO AG 

Germany 


Germany 

USA 

France 

Denmark 

USA 

Germany 

Bulgaria 

USA 

Germany 



Germany 


Switzerland 

Japan 

Belgium 

USA 


USA 

Italy 

Switzerland 

USA 

Switzerland 

Switzerland 


Belgium 

Switzerland 

ENNOV-CLINSIGHT 

Entimo AG 

ERT 

European Medicines Agency 

Eurotrials 

EXTEDO 

FGK Clinical Research GmbH 

Hays Pharma 

Imperial Clinical Research Services 

INC Research 

invivodata, inc. 

Kinapse 

Levy Associates 

LINDEQ 

Lionbridge Life Sciences 

LORENZ Life Sciences Group 

MEDICADEMY 

Medidata Solutions 

monitoforhire.com 

NDA Group 

NextDocs 

nSpire Health 

Ocasa Logistics Solutions 

ORACLE 

PAREXEL International 

Perceptive Informatics 

PFC Pharma Focus Ltd. 

Pharmaceuticals and Medical (PMDA) 

Devices Agency 

France 

Germany 

USA 

EU 

Portugal 

Germany 

Germany 


USA 

USA 

USA 



Norway 

USA 

Germany 

Denmark 


USA 

Sweden 

USA 

USA 

USA 

France 

USA 

USA 

Switzerland 

Japan 

PharmaNet Development Group 

PHT Corporation 

Product Life 

Quadratek Data Solutions Ltd. 

Quality & Compliance Consulting, Inc. 

RBW Consulting 

Real Pharma 

Regulatory Pharma Net 

Regulatory Resources Group Ltd. 

RPS, Inc. 

RWS Translations 

SDL 

Sentrx 

SGS 

Sofus Stockholm Consulting AB 

SRA International 

Swissmedic 

Tarius 

TecHorizon 

Thomson Reuters 

TOPRA 

TransPerfect 

Trilogy Writing & Consulting 

United BioSource Corporation 

Uppsala Monitoring Centre 

Vitalograph 

WCI Consulting Limited 

XClinical 


USA 

France 

Germany 

USA 


Germany 

Italy 


USA 



USA 

France 

Sweden 

USA 

Switzerland 

Denmark 

Italy 

USA 


USA 

Germany 

USA 

Sweden 



Germany

ABOUT GENEVA 

45 


ABOUT GENEVA 

Join us in Geneva... Rejoignez-nous à Genève... 

About Geneva 

Geneva has the perfect location – on the banks of Lake Geneva and at the foot of the Alps. 

Its cosmopolitan flair perfectly reflects the international attendance of the EuroMeeting which 

attracts participants from over 50 countries. Geneva hosts the European headquarters of the 

United Nations, the headquarters of the International Red Cross as well as around 20 more 

major international organisations, 170 NGOs and 200 diplomatic missions. The Jet d’Eau on the 

lake, one of the world’s tallest water fountains shooting water 140 metres in the air, provides an 

excellent point of reference. In your free time, explore Geneva’s past in the old town or visit one 

of the more than 40 museums in the city. Geneva is very much a city of culture. Take a cruise 

on the lake or stroll through one of the waterfront parks. There is something for everyone. If 

you are thinking of extending your visit, head for the mountains. In an hour you can be on top 

of the world – whether to ski or just to enjoy the view and the fresh air. 

Geneva has sometimes been described as one of Europe's most unavoidable cities – everybody 

passes through here at one point thanks to Geneva’s excellent transportation connections. 

Geneva International Airport links the city with the world, complemented by the excellent high 

speed train services to Paris, London and Milan as well as its location at the junction of the 

northern and southern European motorway systems. 

Quick Facts 

Location: Geneva is located in the south-western corner of Switzerland, on the banks of Lake 

Geneva 

Population: The second largest city in Switzerland with an international population of 185,000 

Climate: Pleasant all year round due to the soothing effects of the lake and surrounding 

mountains 

Currency: Swiss Franc 

Language: French, but English is widely spoken 

Hotels: Over 125 quality hotels 

The Convention Centre 

Getting to Geneva 

Geneva Palexpo is ideally 

located right next to the 

international airport with its 

own underground railway 

station about 300m away 

from the arrival and departure 

levels. Simply leave the Palexpo 

Convention Centre and check in 

for your flight. The city centre 

is only 6 minutes away by train. 

In a city with a long tradition 

of high-level meetings, Geneva 

Palexpo has proved itself to be 

one of Europe’s most versatile 

convention centres. 

By plane 

Geneva International Airport (http://www.gva.ch) links 

Geneva to a network of approximately one hundred 

destinations around the world. The Star Alliance 

member airlines are offering EuroMeeting participants 

discounts on airfares to Geneva. See page 47 for 

further details. 

By rail 

The Swiss national rail system (www.rail.ch) has an 

extensive network across Switzerland with hourly 

trains running to cities such as Lausanne, Bern, Basel, 

Zurich and to the popular holiday regions of the 

cantons of Vaud and Valais. The heart of Paris is only 3 

and a half hours away from Geneva by the TGV (high 

velocity train). Reaching a maximum speed of 270 

km/h (170 m/h), city-centre to city-centre travelling 

time compares very favourably with intercity flights.

46 NETWORKING EVENTS 


Networking Opportunities 

Networking is an integral part of the EuroMeeting. Participants 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. 

La Grande Reception 

Monday, 28 March 2011, 17:30-19:30 at the Ramada Park Hotel 

Le Grande Reception is our Monday networking cocktail reception with drinks and snacks 

and an excellent opportunity to renew your existing contacts and to make new ones. It is 

exclusive to EuroMeeting registered participants. The Ramada Park is a short distance from 

the Convention Centre by taxi or by public bus. For your added convenience, there will be 

shuttles from outside the Convention Centre to the Ramada Park starting at 17:15. 

DIA Special Interest Area Communities (SIACs) – 

Meet and Eat 

Tuesday, 29 March 2011, 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 Services Manager will be on hand to answer 

any questions. 

Speed Networking Session 

Tuesday, 29 March 2011, 13:30-14:00 

The EuroMeeting is used as a networking opportunity by all participants. The EuroMeeting Speed Networking session aims to facilitate conversations 

amongst participants. 

Speed networking, 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, 29 March 2011, 17:30-18:30 

Tuesday’s networking reception takes place on the exhibition floor. Drinks and snacks are included. It is open to all registered participants. 

Network on the Exhibition Floor 

All refreshments will be served on the exhibition floor making it the ideal place to meet the people you want to meet. There will be two internet cafés, 

attendee lounges and a cash bar situated on the exhibition floor.

ACCOMMODATION AND TRANSPORT 

47 


Special Hotel Rates for your EuroMeeting 2011 Stay in Geneva 

DIA Europe has negotiated special conference hotel rates for EuroMeeting participants. Rates will include breakfast, service and all taxes. You will receive a 

city-wide Geneva Transport Card at check-in which will give you complimentary access to local transport in the city. 

Please be advised that DIA Europe has only one contracted and exclusive hotel agent for the EuroMeeting 2011: K.I.T. Group. 

DIA Europe works with one agent to ensure that: 

• Your hotel reservations are officially part of the EuroMeeting 

• The hotel 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 rooms can be booked on the DIA EuroMeeting website. Go to www.diahome.org/euromeeting2011 and click on the EuroMeeting icon. For any questions 

please contact dia2011@kit-group.org. 

Book by 17 December 2010 and be entered to 

win an Apple iPad. 

Receive up to 20% off airfares through the Star Alliance Network! 

The Star Alliance member airlines are pleased to be appointed as the Official Airline Network for the 23rd Annual EuroMeeting in Geneva. 

Participating airlines include: 

• ANA 

• Adria Airways 

• Austrian Airlines 

• Blue1 

• bmi 

• Brussels Airlines 

• Croatia Airlines 

• Continental Airlines 

• EgyptAir 

• LOT Polish Airlines 

• Lufthansa 

• SWISS International Air Lines 

• Scandinavian Airlines 

• Spanair 

• TAP Portugal 

• Turkish Airlines 

• United Airlines 

Booking office information can be found at www.staralliance.com/conventionsplus 

1. Choose “For Delegates” 

2. Under “Delegates Login” enter event code SK03A10 

3. Choose one of the participating carriers listed. 

Registered participants plus one accompanying person travelling to the event are automatically granted a discount of up to 20%, depending on class of travel. 

Discounts are offered on most published business and economy class fares, excluding website/internet fares, senior and youth fares, group fares and roundthe-world 

fares. 

Free public transportation in Geneva 

All visitors staying at a hotel in Geneva will receive a free Geneva Transport Card on check-in which enables complimentary use of the entire Geneva public 

transport network without restriction (bus, train and boat) with validity for the entire duration of their stay including their departure day.

CliniCal ForuM 

BasEl 2011 

5 th a nnual 

10-12 October 2011 

Congress Center Basel | Basel, Switzerland

D I A 

2011 

Convergence of Science 

Medicine, and Health 

WHAT TO EXPECT AT 

DIA 2011 

DIA 2011 will feature 15 tracks in a variety of formats to provide you 

with a comprehensive portfolio of educational opportunities and 

unparalleled skills at every stage of the pharmaceutical value chain by: 

• Bringing together industry professionals, clinicians, patient 

representatives, and regulatory agencies from all continents 

• Facilitating knowledge exchange needed to positively impact 

innovation and ultimately patient care and outcomes 

• Building upon DIA’s traditional breadth and depth of topics running 

the gamut from preclinical research through postmarketing safety 

and surveillance 

• Expanding the discussion of current issues to include new areas such 

as comparative effectiveness, health outcomes, and medical devices 

Time Magazine Man of the Year 

Will Deliver Keynote Address 

at DIA 2011 

David D. Ho, MD is the founding 

Scientific Director and Chief Executive 

Officer of the Aaron Diamond AIDS 

Research Center, a world-renowned 

biomedical research institute. He is also 

the Irene Diamond Professor at The 

Rockefeller University. 

47 th Annual Meeting 

June 19-23, 2011 

McCormick Place 

Chicago, IL 

PROGRAM CHAIR 

Kenneth A. Getz, MBA 

Chairman of CISCRP and Senior Research Fellow 

at the Tufts Center for the Study of Drug 

Development 

©2010 Brad Yeo c/o theispot.com 

Dr. Ho has been at the forefront of 

AIDS research for 29 years, publishing more than 350 papers. 

His elegant studies, beginning in 1994, unveiled the dynamic 

nature of HIV replication in vivo and revolutionized our basic 

understanding of this horrific disease (Nature 1995; Science 

1996). This knowledge led Dr. Ho to champion combination 

antiretroviral therapy (N. Engl. J. Med. 1995; Science 1996) that 

resulted in unprecedented control of HIV in patients (Nature 

1997). AIDS mortality in richer nations has declined 6-fold since 

1996, and a massive international effort is now underway to bring 

such life-saving treatment to millions in the developing world. Dr. 

Ho has been the major driving force behind this major medical 

breakthrough in what is arguably the worst plague in human 

history. 

His research team is now devoting considerable efforts to 

developing vaccines to halt the spread of the AIDS epidemic. 

Furthermore, he is now heading up a consortium of Chinese and 

American organizations to help address the crisis of HIV/AIDS in 

China. 

Dr. Ho has received numerous honors and awards, including 

being named Time Magazine’s Man of the Year in 1996, and the 

recipient of a Presidential Medal in 2001. 

For more information on the 2011 DIA Annual Meeting, 

visit www.diahome.org.

50 

23RD ANNUAL EUROMEETING AT A GLANCE 


Pre-Conference Tutorials 09:00 - 12:30 

Plenary 14:00 - 17:15 

La Grande Reception Networking Reception 17:30-19:30 

Theme 1 Theme 2 Theme 3 Theme 4 Theme 5 

Innovation, Future 

of Treatment and 

Personalised Medicine 

Securing Approvals in a 

Changing Environment 

Patient Safety: From Data 

Collection and Integration 

to Benefit/Risk Analysis 

and Risk Minimisation 

Clinical Study Endpoints 

and HTA/Cost 

Effectiveness 

Wider Access 

(Switching/Generics) 


Session 1 

09:10:30 

Session 0101/0701 

Trial Design and Interpretation 

for Personalised Medicine- 

Delivering C21 Drug 

Development 

Session 0201 

The Future of the EU 

Regulatory Landscape 

Session 0301 

Globalisation of Safety: 

Pharmaceutical and Drug 

Safety in Emerging Asia 

Session 0401 

Update on How Agencies 

Assess Therapeutic Value of a 

Product and – Increasingly – 

the Therapeutic Added Value 

Session 0501 

Switching: Is there an ideal 

route? 

Coffee Break 

Session 2 

11:00-12:30 

Session 0102 

The Role of Personalised 

Medicine in Safety 

Session 0202/0302 

Decision-Making Process of 

Benefit/Risk Assessment – 

A collaborative 

framework approach 

Session 0202/0302 

Decision-Making Process of 

Benefit/Risk Assessment – 

A collaborative 

framework approach 

Session 0402 

Can we Merge Two Different 

Worlds? Regulatory review 

for market authorisation 

and HTA assessment for 

reimbursement decision 

Session 0502 

Are New Switches in Line 

with the Expectation of the 

“Empowered Patient”? 

Lunch 

Session 3 

14:00-15:30 

Session 0103 

Developing Personalised 

Medicines – Delivering the 

diagnostics 

Session 0203 

Strategies to Obtain 

Competitive Approvals in a 

Changing Environment 

Session 0303 

From RMP to REMS: Is a Global 

Approach to Risk Management 

Achievable? 

Session 0403 

Comparison of Endpoints for 

Market Authorisation and 

Reimbursement: How can we 

harmonise assessment? 

Session 0503 

Changing Regulatory 

Environment: Impact on the 

self-care sector 

Coffee Break 

Session 4 

16:00-17:30 

Session 0104/1101 

In Vitro Diagnostic 

Session 0204 

Developing Advanced 

Therapy Medicinal Products – 

Challenges and opportunities 

Session 0304 

New Pharmacovigilance 

Legislation: Facilitation and 

transparency 

Session 0404 

Can We Reach Some 

Harmonisation among Europe 

on HTA Review? 

Session 0504 

Is the Patient/Consumer 

Adequately Informed? 


Networking Reception 17:30-18:30 

Session 5 

09:00- 

10:30 

Session 0105 

How to Pay for Personalised 

Medicine? The Value of 

Stratification 

Session 0205/1405 

Implementation of the Revised 

Variations Regulation - Are the 

objectives being met? 

Session 0305 

Risk Minimisation 

Sesison 0405 

FDA Guidance on Patient- 

Reported Outcomes and the 

European Medicines Agency’s 

Paper on Health- Related 

Quality of Life 

Session 0505 

Supply of Quality Medicines to 

Developing Countries 

Coffee Break 

Session 6 

11:00-12:30 

Session 0106 

Qualify, Validate, Apply - 

assuring assay quality through 

the biomarker lifecycle 

Session 0206 

Town Hall Meeting - 

Meet the Regulators 

Session 0306 

Data Sources for 


Assessment 

Session 0406 

Assessing Symptoms in Global 

Clinical Trials to meet FDA and 

European Medicines Agency 

Standards 

Session 0506 

How to Increase Access to 

Biosimilar Medicines 

Lunch 

Session 7 

14:00-15:30 

Session 0107 

Clinical Utility and 

Implementation -The 

gatekeeper for successful 

personalised medicine 

Session 0207 

Meeting the Information Needs 

of the Patient 

Session 0307 

How Better Incident 

Management Prevents Crisis 

Session 0407 

Scientific Advice on Endpoints: 

To comply or not to comply 

Session 0507 

How to Improve the Current 

Regulatory Framework in order 

to Increase Access to 

Generic Medicines 

Coffee Break 

Session 8 

16:00-17:30 

Session 0108 

Personalised Medicines for the 

Real World 

Session 0208 

How to Make the Product 

Available to the Patient 

Session 0308 

Risk Communication and 

Tansparency in the 21st 

Century: Lessons for pharma 

Session 0408 

Public-Private Partnerships – 

Initiatives to reach consensus 

on patient-reported endpoints 

Session 0508 

Pros and Cons of the Current 

Decentralised Procedure 

Generic Applications 

End of Conference

Lunch 

Lunch 


51 


Pre-Conference Tutori 

Plenary 14:0 

La Grande Reception Networki 

Theme 6 Theme 7 Theme 8 Theme 9 Theme 10 Theme 

Engaging the Research 

World! Pre-Clinical 

Research and Development 

Statistics across the 

Drug Lifecycle 

Developing Medicines for 

Special Populations 

Pharma e-World 

CMC, Inspection and 

Assessment, Quality and 

Counterfeiting 

The Drug/D 

Boundary: Is It 

Disappe 


Session 0601 

International Strategy for 

Non-Clinical Consultants 

Session 0101/0701 

Trial Design and Interpretation 

for Personalised Medicine- 

Delivering C21 Drug 

Development 

Session 0801 

Increasing Global Regulatory 

Dialogue 

Session 0901 

Use of Electronic Health 

Records for Clinical Research 

Session 1001 

Development of 

Pharmaceutical Products in the 

Context of the New 

Quality Paradigm 

Session 1 

Keynote Introd 

Setting the 

Coffee B 

Session 0602 

Non-Clinical Evaluation of 

Drug-Induced Hepatotoxicity 

Session 0702 

Using Indirect Comparisons in 

Assessment of Clinical Data 

Session 0802 

Will Modelling and Simulation 

Accelerate Drug Development 

for Children? 

Session 0902 

New Approaches to 

Pharmacovigilance when 

Employing Electronic Health 

Records (EHRs) 

Session 1002 

New Paradigm, Latest 

Development (2): Interaction 

and implementation of 

ICH Q8, Q9 and Q10 

Session 1 

Borderline Prod 

Impact on Dev 

Session 0603/1303 

Safety Aspects in the 

Development of Vaccines 

Session 0703 

Recent Developments in 

Software Solutions for 

Adaptive Trial Designs 

Session 0803 

Can Bridging and Extrapolation 

of Data Reduce the Number 

of Clinical Trials? 

Session 0903 

Comparing ePRO Technologies: 

What works? 

Session 1003 

Variation Regulation: 

Post approval change 

management protocol 

Session 1 

Regulatory Fram 

Combination P 

Coffee B 

Session 0604 

Biobanking: Logistics and 

samples handling 

Session 0704 

Common Issues at SAWP 

(Scientific Advice 

Working Party) 

Session 0804 

Risk Management for 

Special Populations 

Session 0904 

Data Privacy in the 

Pharma e-World 

Session 1004 

Is There a Need for a 

Pharmacopoeia in the New 

Quality Paradigm? 

Session 010 

In Vitro Diag 


Networking Recept 

Session 0605 

Non-Clinical Aspects of 

First-In-Humans 

Session 0705 

Quantitative Approach for 

Benefit/Risk – Challenges 

and Opportunities 

Session 0805 

Challenges and Opportunities 

to Develop Suitable 

Formulations 

Session 0905 

Practical Implementation of 

the CDISC Standards 

Session 1005 

Globalisation of Medicine (1): 

Impact on Quality 

Session 1 

Points to Conside 

Development of C 

Produc 

Coffee B 

Session 0606 

Biomarkers in Non-Clinical 

Safety Assessment 

Session 0706 

Communicating Complex 

Statistical Results 

Session 0806 

Medicines for Geriatric Patients 

Session 0906 

Using Technology to Improve 

the Clinical Trial Process 

Session 1006 

Globalisation of Medicine (2): 

Counterfeiting Aspects 

Session 1 

Development o 

Device 

Session 0607 

The Non-Clinical Development 

of Anti-Cancer Pharmaceuticals 

Session 0707/0907 

Statistical Computing: Progress 

in Computational Science in 

Clinical Trials 

Session 0807/1307 

How Should the Paediatric 

Scheme be Amended 

and Why? 

Session 0707/0907 

Statistical Computing: Progress 

in Computational Science in 

Clinical Trials 

Session 1007 

Paediatric Formulation 

Session 1 

Clinical Develo 

Medical De 

Session 0608 

Contemporary Issues in 

Non-Clinical Development 

of Biotechnology-Derived 

Products 

Session 0708 

Subgroup Analyses 

Session 0808 

Medicines for Pregnant and 

Lactating Women 

Session 0908 

Clinical Trial Technologies and 

the Site: Where next? 

Session 1008 

What’s New in Quality? 

Coffee B 

End of Conf


52 

als 09:00 - 12:30 

0 - 17:15 

ng Reception 17:30-19:30 

11 Theme 12 Theme 13 Theme 14 Theme 15 Theme 16 

evice 

about to 

ar? 

Drug Development in the 

Real World 

Biologicals and Vaccines – 

Access to Innovation 

Knowledge Management 

and Telematics 

Pharmaceutical 

Development: Regional 

Perspectives 

Stand-Alone Sessions/ 

Hot Topics 

101 

uction – 

scene 

Session 1201 

Effective Global Clinical Trial 

Development: Future Trends 

Session 1301 

Pharmacovigilance for 

Biologicals and Vaccines 

Session 1401 

Standardisation: 

How it really helps 

Session 1501 

Turkey 

Session 1501a 

Italy 

Session 1601 

International Cooperation 

Among Regulatory Agencies 

Part 1 

reak 

102 

ucts and 

elopment 

Session 1202 

Cost Reduction Strategies in 

Clinical Trial Conduct 

Session 1302 

Has the New EU Variations 

Regulation Met its Objectives 

of Optimising, Simplifying and 

Rationalising the Regulatory 

Processes for Biologicals 

and Vaccines? 

Session 1402 

Product Information 

Management (PIM): In 

production – migration 

deadline approaching 

Session 1502 

Middle East 

Session 1602 

Heads of Medicines Agencies 

103 

ework for 

roducts 

Session 1203 

Post-Approval Strategies 

Session 0603/1303 

Safety Aspects in the 

Development of Vaccines 

Session 1403 

Best Practice in Electronic 

Information Exchange for 

Regulatory Submissions 

Session 1503 

Japanese Regulatory Session 

Session 1603 

2015 Roadmap 

reak 

4/1101 

nostic 

Session 1204 

Patients: An increasingly 

influential voice in drug 

development 

Session 1304 

Specificities of Clinical Trials 

for Biologicals and Vaccines in 

Emerging Markets 

Session 1404 

Strategic Directions in 

Information Technology across 

the Medicines Network 

Session 1504 

Africa 

Session 1604 

International Cooperation 

Among Regulatory Agencies 

Part 2 

ion 17:30-18:30 

105 

r in Clinical 

ombination 

ts 

Session 1205 

Partnering in Drug 

Development 

Session 1305 

Progress of New Technologies 

Session 0205/1405 

Implementation of the Revised 

Variations Regulation - Are the 

objectives being met? 

Session 1505 

Global Simultaneous Drug 

Development and Globalisation 

of Drug Development: 

Focusing on China 

Session 1605/1606 

GCP Forum 

reak 

106 

f Medical 

s 

Session 1306 

Europe’s Role in Supporting 

the Regulation of Biologicals 

and Vaccines outside Europe 

Session 1406 

Knowledge Management: 

Cultures, behaviours 

and organisations 

Session 1506 

Eastern Europe/Russia 

Session 1605/1606 

GCP Forum 

107 

pment of 

vices 

Session 1207 

Health Organisations and 

their Influence on Drug 

Development 

Session 0807/1307 

How Should the Paediatric 

Scheme be Amended 

and Why? 

Session 1407 

Signal Detection – Making use 

of available data sources 

Session 1507 

Latin America 

Regulatory Session 

Session 1607 

WHO-TDR: An update 

reak 

Session 1208 

Investigator-Led Clinical Drug 

Development 

Session 1308 

Global Access to Vaccines 

Session 1408 

Knowledge Management: 

Technologies 

Session 1508 

India 

Session 1608 

ENCePP 

erence

EuroMeeting Key Contacts 

Go to the EuroMeeting website www.diaeurope.org/euromeeting2011 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. 

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 participants with last names A-M please contact Roxann Schumacher at roxann.schumacher@diaeurope.org or 

+41 61 225 51 38 

For participants 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 at dermot.ryan@diaeurope.org 

or +41 61 225 51 32 

DIA Europe is committed to the active participation of students in the EuroMeeting and offers a special €100 

(+VAT) student rate. Please contact DIA Customer Services on +41 61 225 51 51 to register for this rate. 

Have you seen the EuroMeeting 2011 website? 

Simply go to www.diaeurope.org/euromeeting2011 

You will be able to: 

• Register online for the meeting 

• Download a registration form to fax to DIA 

• Get information on being an exhibitor 

• Find out more about student and young professional activities 

• Take advantage of specially-negotiated hotel rates in Geneva 

• Learn more about the city of Geneva 

DIA has created a group on the social 

networking site, LinkedIn: 

DIA 23rd Annual EuroMeeting 

28-30 March 2011 | Geneva, Switzerland 

• Connect with speakers, participants and exhibitors prior to the conference 

• Share ideas and experiences with colleagues in your field 

• Arrange meetings and network online with fellow delegates 

• Speakers will lead discussions on topics that will be covered at the EuroMeeting 

• Latest news on the conference programme and confirmed speakers 

• Updates on the conference networking events, hotels, travel and transport information 

Visit www.linkedin.com > search groups > DIA 23rd Annual EuroMeeting

REGISTRATION FORM 

23rd Annual EuroMeeting 

28-30 March 2011 | Palexpo, Geneva, Switzerland 

ID # 11101 

If DIA cannot verify your membership upon receipt of registration form, you will be charged the non-member fee. 

The fee is inclusive of lunch and coffee breaks of EUR 125.00 per day. Please note: from 01.01.2011 VAT will be charged 8% 

Early-Bird rates available for Members: 

Deadline on or before 28 January 2011 

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 28 January 2011) FEE VAT 7.6% 

TOTAL 

Join DIA now to qualify for the Early-Bird Rate € 115.00 n/a 

€ 115.00 

Early-Bird Industry € 1’625.00 € 123.50 € 1’748.50 

CATEGORY Member (after 28 January 2011) Non-Member (with optional membership) Non-Member (without optional membership) 

FEE VAT 7.6% TOTAL FEE VAT 7.6% Membership TOTAL FEE VAT 7.6% TOTAL 

Industry € 1’780.00 € 135.28 € 1’915.28 € 1’780.00 € 135.28 € 115.00 € 2’030.28 € 1’915.00 € 145.54 € 2’060.54 

Charitable/Non-profit/Academia (Full-Time) € 1’335.00 € 101.46 € 1’436.46 € 1’335.00 € 101.46 € 115.00 € 1’551.46 € 1’470.00 € 111.72 € 1’5 81.72 

Government (Full-Time) € 890.00 € 67.64 € 957.64 € 890.00 € 67.64 € 115.00 € 1’072.64 € 1’025.00 € 77.9 0 € 1’102.90 


Tutorial Fee € 370.00 € 28.12 € 398.12 

Special Roundtable 1 € 150.00 € 11.40 € 161.40 

Please indicate the tutorial number you wish to attend _________________ 

(see pages 9-14 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 RATES AND GROUP DISCOUNTS ARE AVAILABLE! PLEASE CONTACT THE DIA FOR MORE INFORMATION. 

11101DIAWEB 

REGISTRANT 

PLEASE COMPLETE IN BLOCK CAPITAL LETTERS OR MAKE REGISTRATION EVEN 

SIMPLER 

BY ATTACHING THE REGISTRANT’S BUSINESS CARD HERE 

Prof Dr Ms Mr 

Last Name 

PAYMENT METHODS - Credit cards are our preferred payment method. 

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. 

VISA MC AMEX 

First Name 

Card Number 

Company 

Exp. Date 

Job Title 

Cardholder’s Name 

Street Address / P.O. Box 

Date 

Cardholder’s Signature 

Postal Code 

City 

Cheques should be made payable to: DIA and mailed together with a copy of the registration form 

to facilitate identification to: DIA Europe, Elisabethenanlage 25, Postfach, 4002 Basel, Switzerland 

Country 

Fax (Required for confirmation) 

Telephone 

Email (Required to receive presentation download instructions) 

Please indicate your professional category: Academia Government 

Industry Contract Service Organisation 

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# 11101 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. 

Persons under 18 are not allowed to attend DIA meetings. 

CANCELLATION POLICY All cancellations must be in writing and received with DIA Europe by 17:00 CET on 18 March 2011 

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. Registered attendees who do not cancel by the date above and do not attend, will be responsible for the full registration fee. Registered attendees are 

responsible for cancelling their own hotel reservations. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe 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 attendees will be responsible for the 

non-member fee, if applicable. Please notify DIA Europe office of any such substitutions as soon as possible. 

IMPORTANT: 

Hotel and travel reservations should be made ONLY after receipt of written registration confirmation from DIA Europe. 

If you have not received your confirmation within five working days, please contact DIA Europe. 

HOW TO REGISTER 

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. 

Online www.diahome.org Fax +41 61 225 51 52 Email diaeurope@diaeurope.org Mail 

DIA Europe 

Postfach, 4002 Basel, Switzerland 

All registrations received at the DIA European Office by 18:00 CET on 18 February 2011, will be included in the Attendee List. 

© DIA 2010

EuroMEEting - Genetic Alliance UK

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?