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

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Disclosure Policy It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the programme audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabelled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials. Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA. 2 Table of Contents This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Disclosure Policy............................................................................................................................................................................................................................................. 2 Welcome from the EuroMeeting 2009 Co-Chairs................................................................................................................................................................................ 3 Programme Advisors..................................................................................................................................................................................................................................... 3 Theme Leaders............................................................................................................................................................................................................................................... 4 Plan Your EuroMeeting Experience.......................................................................................................................................................................................................... 5 Opening Plenary Session..............................................................................................................................................................................................................................6 Student and Young Professionsal Session..............................................................................................................................................................................................7 Agency Satellite Session..............................................................................................................................................................................................................................7 Japanese Regulatory Session....................................................................................................................................................................................................................7 Session Topics in Specific Interest Areas...........................................................................................................................................................................................8-9 EuroMeeting Special Programmes.........................................................................................................................................................................................................10 Pre-Conference Tutorials......................................................................................................................................................................................................................11-16 Greening the EuroMeeting.......................................................................................................................................................................................................................17 Accreditation and Credit Designation.................................................................................................................................................................................................16 Sessions: Theme 1-14..........................................................................................................................................................................................................................18-40 Hot Topics and Stand-Alone Sessions.........................................................................................................................................................................................40-44 Exhibitors...................................................................................................................................................................................................................................................46 About Monaco..........................................................................................................................................................................................................................................47 Accommodation in Monaco ................................................................................................................................................................................................................48 Monaco Tours...........................................................................................................................................................................................................................................49 Networking Opportunities...................................................................................................................................................................................................................50 Discounted and Complimentary Transportation Offers............................................................................................................................................................. 51 EuroMeeting at a Glance...............................................................................................................................................................................................................52-54 Key Contacts...........................................................................................................................................................................................................................................53 Registration Form.................................................................................................................................................................................................................................54
Welcome from the EuroMeeting 2010 Co-Chairs Bruno Flamion and Kerstin Franzén Dear Colleague, It is our pleasure to invite you to participate in the 22nd Annual EuroMeeting in Monaco, 8-10 March 2010. Three days of discussion, sharing of experience, debating and networking will show the vitality of drug development in Europe and across the world. Whether you are a session chair, speaker, tutorial instructor or attendee, and whether you are from a regulatory agency, academia, industry or a patient group, or a student or young professional, we believe you can play a key role in building the success of the EuroMeeting and ensuring its place as one of the most important European conferences for professionals involved in the development of medicines. When deciding on the themes, we have chosen the integrated, multi-disciplinary approach. The aim is to generate interest from as many disciplines as possible and to create a lively platform for a debate on development but also market access of medicines in Europe. We are aware that many of you will be looking for your specific area of interest in the programme such as non-clinical aspects, statistics, IT, etc. The Session Finder on pages 8-9 will highlight which sessions will discuss these aspects. We trust that you will build your own theme. Why not take this opportunity to look across the board and find exciting cross-disciplinary topics? Monaco is an exciting location, well-known to most people. Despite being a small country, it has a lot to offer and is very hospitable and culturally interesting. No doubt there are numerous challenges around but we strongly believe you should not miss this opportunity to bring your contribution to the debate on drug development. Make your plans to come to Monaco in March 2010! Bruno Flamion and Kerstin Franzén Programme Advisors Melek Bostanci Onol, DRA Manager, Boehringer Ingelheim Ilac Ticaret A.S., Turkey Daniel Brasseur, Chair PDCO, Senior Member, Federal Drug Agency, Belgium Emmanuel Chantelot, Executive Director, European Biopharmaceutical Enterprises (EBE), Belgium Daan Crommelin, Scientific Director, Top Institute Pharma, The Netherlands Anne de Bock, Portfolio Leader Oncology & Antiinfectives, AstraZeneca, Belgium Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Julianne Hull, Senior Director, Global Development Data Operations, Wyeth Research, UK Robert Hemmings, Statistics Unit Manager, MHRA, UK Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The Netherlands Tim Kievits, CEO, PamGene, Chair of EuropaBio Personalised Medicines Working Group, The Netherlands Ingrid Klingmann, Managing Director, Pharmaplex, Belgium Jytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark José Ramet, Professor, University of Antwerp, Chairman, Paediatric Department, University Hospital Antwerp and Queen Paola Children’s Hospital, Belgium Andrea Rappagliosi, Vice President European Government Affairs & Head of Brussels Office, GlaxoSmithKline, UK Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg Malcolm Rowland, Emeritus Professor, School of Pharmacy and Pharmaceutical Sciences University of Manchester, England Agnès Saint Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU Christian Schneider, Chair CAT, European Medicines Agency, Acting Head, Division EU Cooperation/Microbiology, Paul-Ehrlich-Institut, Germany Bruno Flamion Professor, Clinical Pharmacology, University of Namur, Belgium and Chair, CHMP, Scientific Advice Working Party, European Medicines Agency Bruno Flamion is an MD who practised internal medicine and nephrology in Belgium. He was a Research Fellow at the NIH (1988-1992) and with the Belgian National Fund for Scientific Research (1992-1996) and later got a PhD in physiological sciences from the University of Brussels. He is now Full Professor of Physiology and Pharmacology at the University of Namur, Belgium, where he heads a molecular physiology lab. He has been involved as a medical expert for the Belgian Federal Agency for Medicines and Health Products (FAMHP) since 1999 and for the European Medicines Agency: CHMP, PK group, Pharmacogenomics, and more recently CAT (Committee for Advanced Therapies). His favourite activity is chairing the Scientific Advice Working Party. Kerstin Franzén Senior Director, Regulatory Policy & Intelligence, Pfizer, Sweden Kerstin Franzén has a background in Regulatory Affairs covering 29 years. After an academic degree at Uppsala University, M Pharm Sci, she joined the pharmaceutical industry, first for a short period in the marketing area, and then went into the regulatory arena. The first seven years were spent with the Roche affiliate in Sweden, followed by a move to the Swiss headquarters where she stayed for four years, still in Regulatory Affairs. In 1990 she decided to join Kabi Pharmacia and go back to Sweden. This company went through a number of mergers and acquisitions, which eventually led to her current position with Pfizer in Regulatory Policy & Intelligence, an area she has been involved in since 1998. Beatriz Silva Lima, CHMP, European Medicines Agency, Professor, Pharmacology, University of Lisbon, INFARMED, Portugal Susie Stephens, Director of Biomedical Informatics, Johnson and Johnson Pharmaceutical R&D, UK Wolfgang Summa, Executive Vice President, Business Development, OmniComm Systems, Germany Erik Tambuyzer, Senior Vice President, Corporate Affairs, Europe and International, Genzyme, Belgium Catherine Tuleu, Senior Lecturer and Deputy Director, The School of Pharmacy, University of London, UK Noël Wathion, Head of Patient Health Protection, European Medicines Agency, EU Paul Woods, Global Compliance Policy Director, AstraZeneca, UK 3
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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