Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
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This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.<br />
Hot Topics/Stand-Alone Sessions<br />
<strong>Monday</strong>, <strong>March</strong> 08, <strong>2010</strong><br />
16:30 Session 1401<br />
CONSEQUENCES OF SECTOR INQUIRY - UNDERESTIMATED BY THE<br />
BUSINESS?<br />
Session Chair:<br />
Anne N. Nielsen, Vice <strong>Pre</strong>sident and Senior Counsel, Europe and Asia Pacific,<br />
Bristol-Meyers Squibb, USA<br />
Session under development.<br />
Session 1501<br />
NEW REQUIREMENTS FOR MISSING DATA HANDLING - A PROBLEM THAT<br />
AFFECTS EVERY SUBMISSION<br />
Session Chair:<br />
David Wright, Senior Statistical Assessor, MHRA, UK<br />
Session under development<br />
NON-CLINICAL SAFETY<br />
Session Chair:<br />
Gerd Bode, Consultant, Lecturer, University of Göttingen, Germany<br />
Session 1601<br />
This session will inform participants about the newest guidelines or revisions of<br />
implemented guidelines for the safety evaluation of small molecules and<br />
biotechnology-derived products. These presentations will be given by ICH Topic<br />
Leaders.<br />
ICH S6 – Revision of the Guideline for Biotechs<br />
Jennifer Sims, Head of <strong>Pre</strong>clinical Development, Novartis Pharma AG,<br />
Switzerland<br />
ICH S2 – New Concepts for Genotoxicity Testing<br />
Peter Kasper, Scientific Director, BfArM, Germany<br />
ICH S9 – Strategies for Anticancer Pharmaceutical<br />
Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM,<br />
Germany<br />
ICH M3 – New Recommendations for Timing and Patient Populations<br />
David Jones, Expert Pharmacotoxicologist, MHRA, UK<br />
Tuesday, <strong>March</strong> <strong>09</strong>, <strong>2010</strong><br />
<strong>09</strong>:<strong>00</strong> Session 1402<br />
REGULATORY PERSPECTIVES ON COMBINATION PRODUCTS IN THE EU AND<br />
THE US<br />
Session Chair:<br />
Sabina Hoekstra-van den Bosch, Senior Advisor, Department of Pharmaceutical<br />
Affairs and Medical Technology, Ministry of Health, Welfare and Sport, The<br />
Netherlands<br />
Combination products of drugs and devices are regulated by a mix of elements<br />
from both the pharmaceutical and medical device legislation. The composition<br />
of the 'regulatory mixture' for combination products differs in EU and US. This<br />
session will explain and highlight the philosophy and background of the<br />
relevant provisions of combination products in EU and US from a regulatory<br />
point of view.<br />
Combination Products in the EU: "Lost in Legislation"?<br />
Jos Kraus, Senior Inspector, Health Care Inspectorate, The Netherlands<br />
Hot Topics/Stand-Alone Sessions<br />
Notified Body: Passport to EU for Combination Products?<br />
Gert Bos, Head of Regulatory and Clinical Affairs, Healthcare, BSI, UK<br />
Office of Combination Products: The US Experience.<br />
FDA speaker invited<br />
Session 1602<br />
IMPLEMENTATION OF Q8, Q9 AND Q10: POINTS FOR FURTHER EXPANSION,<br />
DISCUSSION AND CLARIFICATION<br />
Session Chair:<br />
Fritz Erni, Consultant, Switzerland<br />
QbD Analytical Methods<br />
Matthias Pohl, Novartis Pharma AG, Switzerland<br />
Control Strategy/Batch Release Strategy<br />
Jacques Morenas, Associate Director, Inspection and Companies Department,<br />
Chairman of PIC/S, Afssaps, France<br />
Knowlegde Management<br />
Georges France, Vice <strong>Pre</strong>sident, Quality & Compliance Europe, EFPIA Topic<br />
Leader ICH Quality IWG, Wyeth Europa Ltd., UK<br />
11:<strong>00</strong> Session 1403<br />
PRACTICAL EXPERIENCES WITH BORDERLINE COMBINATION PRODUCTS<br />
Session Chair:<br />
Barry Burnstead, Consultant, Select CRO, UK<br />
Bringing a combination product to market possesses the challenges existing<br />
within both the drug and device worlds. What is the reality confronted by<br />
sponsors and how explicit are the regulations in providing a framework in which<br />
to succeed. This session will relate the practicalities experienced in three key<br />
areas of development.<br />
Optimising Development to Meet Global Regulatory Requirements<br />
Ian Purdy, Vice <strong>Pre</strong>sident Scientific Affairs, Boston Scientific, Ireland<br />
Ensuring Compliance in Safety Reporting on Combination Products<br />
Helena Van den Dungen, Global Head Drug Safety and Epidemiology Quality<br />
Assurance, Novartis Pharma AG, Switzerland<br />
Designing Clinical Programmes for Drug Device Combinations<br />
Speaker invited<br />
DRUG SUBSTANCE<br />
Session Chair:<br />
Diana Van Riet, Coordinator, Regulatory Affairs, RIVM, the Netherlands<br />
Session under development<br />
Session 1603<br />
14:<strong>00</strong> Session 1404<br />
EUROPEAN MEDICINES AGENCY ROAD MAPS<br />
Session Chair:<br />
Rolf Bass, Professor for Pharmacology and Toxicology, University Berlin-<br />
Charite, Germany, and University of Basel, Switzerland<br />
Achievements of the <strong>2010</strong> Road Map<br />
Thomas Lönngren, Executive Director, European Medicines Agency, EU<br />
Road Map to 2015<br />
Noël Wathion, Head of Patient Health Protection, European Medicines Agency,<br />
EU<br />
Industry<br />
Susan Forda, Vice <strong>Pre</strong>sident, International Regulatory Affairs, Eli Lilly, UK<br />
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