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09101 Theme Outlines 160408.Qxp 21st Annual EUROMEETING Berlin 2009 Call for Contributions MARCH 23-25, 2009 INTERNATIONALES CONGRESS CENTRUM BERLIN, GERMANY Welcome from the EuroMeeting 2009 Co-Chairs - Barry Burnstead and Dr. Susanne Keitel Dear Friends and Colleagues, We have great pleasure in inviting you to participate in three days of discussion, information and networking at the 21st Annual EuroMeeting in Berlin, March 23-25, 2009. Whether your involvement is as a session chair, speaker, tutorial instructor, student, emerging professional, exhibitor, patient representative or attendee, we believe you can play a key role in building on the success of the EuroMeeting and ensuring its place as one of the most important European conferences for the professional involved in drug development. Berlin was chosen as the EuroMeeting 2009 location not just because of its position at the heart of Europe, but also for its dynamism, accessibility, range of good hotel and cultural options, not to mention the excellent conference facilities at the ICC. We will be concentrating on building the scientific programme over the coming months. This is an exciting process and we urge you to consider being part of it. Information is available here on how to become a EuroMeeting speaker by submitting a presentation abstract. We look forward to seeing you in Berlin next year. Barry Burnstead Director of Standards, i3 Global, UK Barry Burnstead has worked in the pharmaceutical industry for 35 years. Formative years were spent in chemistry, project management and biometrics at SmithKline Beecham. He entered the CRO world in 1991, and a year later with colleagues founded a CRO in Germany and established CRUs in Sweden and the UK. In 1999, he decided to concentrate on consulting and joined Domain Pharma. When Phase Forward acquired Domain, he became global Head of Programme Management. Barry joined i3 Statprobe in August 2006 as Director of Project Management and after one year moved to a central role in leading standards implementation. Dr Susanne Keitel Director, European Directorate of the Quality of Medicines and Healthcare (EDQM), EU Dr. Susanne Keitel joined BfArM in 1997 after 10 years in pharmaceutical development in industry. In the following 10 years with BfArM, she held, amongst others, the positions of Head of Pharmaceutical Quality and Head of EU, International Affairs. She has been a member of various EU working parties, including QWP, PEG, NtA, and, on an international level, ICH Expert Groups. Since October 2007, Susanne is Director of the Council of Europe’s European Directorate for the Quality of Medicines & HealthCare (EDQM). 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. This convergence affords attendees the opportunity to network with professional colleagues from around the world. The DIA is a professional association of approximately 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products. We are committed to the broad dissemination of information on the development of new medicines or generics and biosimilars, with continuously improved professional practice as the goal. The DIA is a financially independent non-profit organisation that funds itself from meeting and membership fees. The voluntary efforts of DIA members and speakers allow the DIA to organise conferences, workshops and training courses and provide publications at a reasonable, competitive cost. Do you have a question about the EuroMeeting? Contact Dermot Ryan at DIA Europe: [email protected] About THEME AND TOPICS FOR 2009 - PLEASE USE AS A GUIDE FOR SUBMITTING YOUR ABSTRACT Theme 1 Theme 6 Theme 11 Auditing and Compliance Medical Device Drug Combination: Optimising Drug Development through Co-Chairs: Gabriele Schwarz, Head, GCP Inspection The Medical Opportunities and Regulatory Sound Methodology Services, BfArM, Germany Challenges of the 21st Century Co-Chairs: Jürgen Kübler, Global Head Integrated Safety Helena Van den Dungen,Head, GCP Inspection Co-Chairs: Andreas Grund, General Manager, & Health Economics Biostatistics, Services,Novartis Pharma Services, GCP-Service, Germany Novartis Pharma AG, Switzerland The Netherlands Sabina Hoekstra-van den Bosch, Senior Advisor, Ministry Robert Hemmings, Statistics Unit Manager, MHRA, UK of Health, Welfare and Sport, The Netherlands Theme 2 Theme 12 Regulatory Controversies Theme 7 Health Economics & Health Technology Assessments and New Challenges Project Management in a Changing Environment What Can We Afford and What Not? Assessing Chair: Kerstin Franzén, Senior Director Worldwide Chair: Suzy de Cordt, Group Leader, What Is Sustainable, Socially Acceptable and Regulatory Policy and Intelligence, Pfizer AB, Sweden Senior Project Manager, Merck Serono, Switzerland Equitable in Supporting Access to Innovation. Co-Chairs: Catarina Edfjäll, Head of Regulatory Affairs Theme 3 Theme 8 Europe, Celgene International SARL, Switzerland Clinical Research Media, Society and Research Wills Hughes-Wilson, Director Health Policy Europe, Increased Complexity by Integration Co-Chairs: Nikos Dedes, Co-chair, Genzyme, Belgium of Real Life Settings Patients' and Consumers' Working Party (PCWP), Carolin Miltenburger, Director Health Economics & Co-Chairs: Norbert Clemens, Head Clinical Development, EMEA, EU Outcomes, i3 Innovus CRS Mannheim GmbH, Germany Yann Le Cam, CEO, EURORDIS, France Alar Irs, Deputy Director, State Agency Medicine, Estonia Theme 13 Theme 9 Preclinical-clinical Interface: Theme 4 Future of Drug Development and Manufacture How to Improve Success in Developing Europe’s Role in Global Innovation Co-Chairs: Barbara Sickmüller, Deputy Director General Innovative Medicines Epidemiology, PV, Risk Management and Association of the German Pharmaceutical Industry, Co-Chairs: Bert Haenen, Toxicologist, Post- authorisation Studies: Germany Organon Schering-Plough, The Netherlands Strategies to Better Protect Public Health Christine Mayer-Nicolai, Senior Regulatory Intelligence Klaus Olejniczak, Scientific Director, BfArM, Germany Chair: Monika Pietrek, MD PhD, MSc, Germany Expert, Merck KGaA, Germany Theme 14 Theme 5 Theme 10 Biomarkers and Personalised Medicine Knowledge Management Impact of Technology and Standards Chair: Michael Zuehlsdorf, Novartis Pharma AG, Chair: John Wise, Senior Director, Informatics, on Drug Development: Switzerland Daiichi Sankyo, UK Now Better, Safer and Faster? Co-Chairs: Peter Stokman, Senior Director Clinical Data Theme 15 Management, Organon Schering-Plough, Generic Medicinal Products The Netherlands Chair: Suzette Kox, Senior Director, Scientific Affairs, Valdo Arnera, General Manager- Europe, EGA, Belgium PHT Corporation, Switzerland THEME OUTLINES FOR 2009 Theme 3 Clinical Research Theme 4 Increased Complexity by Integration of Real Life Settings Europe’s Role in Global Innovation Theme on Epidemiology, PV, Risk Management and Post- Norbert Clemens authorisation Studies: Strategies to Better Protect Public Health Head Clinical Development, CRS Mannheim GmbH, Germany Monika Pietrek Alar Irs MD PhD, MSc, Germany Deputy Director, State Agency Medicine, Estonia • Disease versus Pharmacovigilance Surveillance Systems - How Good is our • Paediatric Trials – Practical Issues Baseline Data? • Patient Reported Outcomes • EU -Harmonized PV Requirements versus Global PV - Supplement or Contradiction? • Strategy of Clinical Development • Technology Impact on Safer Medicines - Myth or Fact? Embracing EDC and ePRO to Capture and Report SAEs • First in Man Studies • Implications of Global Manufacturing and Process Change • Integrated Session with Patient Representatives • Communication and Collaboration between Regulators, Industry, Patients and Prescribers - How much Progress Has Been Achieved? • Novel Clinical Approaches • Methodological Improvements for Safety Decision Making - An Update on • Multinational Trials in China, Africa and South America Infectious Diseases State of the Art • Conditional Approval • Non-clinical Testing and its Contribution to Avoid Harm-ACritical Assessment • Special Requirements for the Safety of Biologicals, Combination Products and Biosimilars • The Pediatric Regulation and its Impact on Children’s Health • Performance and Quality Control in PV and RM • Strategies for Monitoring Safety during Development Life-cycle Safety Surveillance Plans THEME OUTLINES FOR 2009 Theme 6 Theme 7 Medical Device Drug Combination: Project Management in a Changing Environment The Medical Opportunities and Regulatory Challenges of the Suzy de Cordt 21st Century Group Leader, Senior Project Manager, Merck Serono, Switzerland Andreas Grund General Manager, GCP-Service, Germany Sabina Hoekstra-van den Bosch Senior Advisor, Ministry of Health, Welfare and Sport, The Netherlands • Device Legislation for Pharmaceutical Oriented People • Project Manager - Leader or Co-ordinator? • New and Updated Regulations: How Do They Effect Medical Device Drug • Project Management Tools - A Help or Hindrance? Combinations? • Using Project Management to Improve Quality • How to Develop/Change SOPs for Drug Device Combinations: What Impact Does Device Development Have on a Pharmaceutical Company • How to Capitalise on Knowledge-generated Products • Quality
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