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

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40 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 11:00 Session 1303 SIMPLIFICATION OF EU CLINICAL TRIALS FRAMEWORK: A POSSIBILITY? Session Chair: Mats Ericson, Regulatory Policy Director, Amgen, France This session aims to explore ways to reduce administrative burden and to streamline the regulatory supervision of clinical trials in the EU, shorter- and longer term. A recent initiative is the so called voluntary harmonisation procedure (‘VHP’). Learnings from the first year will be presented from the point of view of the Clinical Trials Facilitation Group and of a commercial sponsor, respectively Voluntary Harmonisation Procedure Harmut Krafft, Head, Clinical Trials Unit, Paul-Ehrlich-Institut, Germany Presentation title Stefan Führing, DG Enterprise, European Commission, EU Industry View Georgios Amexis, Global Regulatory Oncology/Regulatory Oncology EU I, Merck Serono KGaA, Germany 14:00 Session 1304 eCTD – CONTINUING IMPLEMENTATION – FACTORS AFFECTING Session Chair: Andrew Marr, Director, Global e-Regulatory Development, Global Regulatory Operations, GlaxoSmithKline, UK The use of the eCTD is becoming more routine but many factors are affecting how it will be used. It is never static. The Centralised Procedure is most advanced with implementation and European Medicines Agency are looking to increase efficiency of handling. A new set of guidances from Switzerland have been issued to support implement the eCTD from 2010 and the new Variations regulations has impacts upon the way that eCTD will be used. eCTD in the Centralised Procedure – Where to from here? Tim Buxton, Head of Sector, Project Management, European Medicines Agency, EU Swissmedic’s Implementation of the eCTD Stephan Järmann, SIMES Project Manager, SwissMedic, Switzerland The Use of e-Submissions within the Context of the New Variations Regulations Geoff Williams, e-Regulatory Liaison, Regulatory Operations, Roche Products, UK 16:00 Session 1305 TRANSPARENCY FROM CLINICAL TRIALS - ARE WE PATIENT-FOCUSED? Session Chair: Fergus Sweeney, Head of Compliance and Inspections, European Medicines Agency, EU Session under development. Theme 13 - Hot Topics/Stand-Alone Sessions Wednesday, March 10, 2010 09:00 Session 1306 e-SUBMISSIONS IN MRP/DCP AND NATIONAL PROCEDURES: WHEN WILL ALL EU AUTHORITIES AND THE INDUSTRY SWITCH TO ELECTRONIC-ONLY? A PANEL DISCUSSION Session Chair: Karin Gröndahl, Head of Registration and Information Management, MPA, Sweden Not all the EU authorities are ready for electronic only submissions despite the HMA agreement of 2005 in Reykjavik which stated 31 December 2009 as the deadline. Why could this goal not be fully met? What are the plans for further development in this direction? Will the eCTD one day be mandatory for MRP/DCP? Industry often points out the problems with meeting the different national requirements of each NCA and also that NeeS will still be needed in the future. Why is the NeeS format chosen so often? What are the obstacles to submitting eCTDs in MRP/DCP and how should they be overcome? A panel of stakeholders from industry and EU authorities will discuss different issues on e-Submission within MRP, DCP and National Procedures and questions from the audience will be encouraged. Aginus Kalis, Director General, Medicines Evaluation Board, The Netherlands Miguel Bley, Chair of TIGes, London Bureau Representative European Medicines Agency, Afssaps, France Remco Munnik, Regulatory Affairs Information Manager, Sandoz B.V., The Netherlands Geoff Williams, e-Regulatory Liaison, Roche Products Ltd, UK 11:00 Session 1307 EXPLORATORY CLINICAL TRIALS IN THE EU Session Chair: David Laurie, Regulatory Policy Expert, DRA Management, Novartis Pharma AG, Switzerland Requirements for Exploratory Clinical trials According to ICH M3 David Jones, Expert Pharmacotoxicologist, MHRA, UK Use of Exploratory Clinical Trials in Industry: When and how to take decisions Speaker invited Exploratory Clinical Trials: Experience from Regulatory Agencies Walter Janssens, Senior Assessor Pre-Clinical Department Research & Development, Federal Agency for Medicines and Health Products, Belgium 14:00 Session 1308 MANAGING THE END-OF-PATENT FOR A MEDICINAL PRODUCT Session Chair: Elizabeth L. Coulson, Vice President, Pfizer Ltd., UK Session under development Latest News: The DIA is delighted to announce the addition of four sessions which will cover quality/CMC issues and their interaction with other pharmaceutical areas. These sessions (sessions 1602-1605) will take place on Tuesday, March 9, 2010. Details will be available as soon as possible on the DIA website.
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Hot Topics/Stand-Alone Sessions Monday, March 08, 2010 16:30 Session 1401 CONSEQUENCES OF SECTOR INQUIRY - UNDERESTIMATED BY THE BUSINESS? Session Chair: Anne N. Nielsen, Vice President and Senior Counsel, Europe and Asia Pacific, Bristol-Meyers Squibb, USA Session under development. Session 1501 NEW REQUIREMENTS FOR MISSING DATA HANDLING - A PROBLEM THAT AFFECTS EVERY SUBMISSION Session Chair: David Wright, Senior Statistical Assessor, MHRA, UK Session under development NON-CLINICAL SAFETY Session Chair: Gerd Bode, Consultant, Lecturer, University of Göttingen, Germany Session 1601 This session will inform participants about the newest guidelines or revisions of implemented guidelines for the safety evaluation of small molecules and biotechnology-derived products. These presentations will be given by ICH Topic Leaders. ICH S6 – Revision of the Guideline for Biotechs Jennifer Sims, Head of Preclinical Development, Novartis Pharma AG, Switzerland ICH S2 – New Concepts for Genotoxicity Testing Peter Kasper, Scientific Director, BfArM, Germany ICH S9 – Strategies for Anticancer Pharmaceutical Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany ICH M3 – New Recommendations for Timing and Patient Populations David Jones, Expert Pharmacotoxicologist, MHRA, UK Tuesday, March 09, 2010 09:00 Session 1402 REGULATORY PERSPECTIVES ON COMBINATION PRODUCTS IN THE EU AND THE US Session Chair: Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The Netherlands Combination products of drugs and devices are regulated by a mix of elements from both the pharmaceutical and medical device legislation. The composition of the 'regulatory mixture' for combination products differs in EU and US. This session will explain and highlight the philosophy and background of the relevant provisions of combination products in EU and US from a regulatory point of view. Combination Products in the EU: "Lost in Legislation"? Jos Kraus, Senior Inspector, Health Care Inspectorate, The Netherlands Hot Topics/Stand-Alone Sessions Notified Body: Passport to EU for Combination Products? Gert Bos, Head of Regulatory and Clinical Affairs, Healthcare, BSI, UK Office of Combination Products: The US Experience. FDA speaker invited Session 1602 IMPLEMENTATION OF Q8, Q9 AND Q10: POINTS FOR FURTHER EXPANSION, DISCUSSION AND CLARIFICATION Session Chair: Fritz Erni, Consultant, Switzerland QbD Analytical Methods Matthias Pohl, Novartis Pharma AG, Switzerland Control Strategy/Batch Release Strategy Jacques Morenas, Associate Director, Inspection and Companies Department, Chairman of PIC/S, Afssaps, France Knowlegde Management Georges France, Vice President, Quality & Compliance Europe, EFPIA Topic Leader ICH Quality IWG, Wyeth Europa Ltd., UK 11:00 Session 1403 PRACTICAL EXPERIENCES WITH BORDERLINE COMBINATION PRODUCTS Session Chair: Barry Burnstead, Consultant, Select CRO, UK Bringing a combination product to market possesses the challenges existing within both the drug and device worlds. What is the reality confronted by sponsors and how explicit are the regulations in providing a framework in which to succeed. This session will relate the practicalities experienced in three key areas of development. Optimising Development to Meet Global Regulatory Requirements Ian Purdy, Vice President Scientific Affairs, Boston Scientific, Ireland Ensuring Compliance in Safety Reporting on Combination Products Helena Van den Dungen, Global Head Drug Safety and Epidemiology Quality Assurance, Novartis Pharma AG, Switzerland Designing Clinical Programmes for Drug Device Combinations Speaker invited DRUG SUBSTANCE Session Chair: Diana Van Riet, Coordinator, Regulatory Affairs, RIVM, the Netherlands Session under development Session 1603 14:00 Session 1404 EUROPEAN MEDICINES AGENCY ROAD MAPS Session Chair: Rolf Bass, Professor for Pharmacology and Toxicology, University Berlin- Charite, Germany, and University of Basel, Switzerland Achievements of the 2010 Road Map Thomas Lönngren, Executive Director, European Medicines Agency, EU Road Map to 2015 Noël Wathion, Head of Patient Health Protection, European Medicines Agency, EU Industry Susan Forda, Vice President, International Regulatory Affairs, Eli Lilly, UK 41
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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