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

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32 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 16:00 Session 0805 CHMP OVERVIEW Session Chair: Brenton James, Consultant in Strategic Regulatory Affairs in the European Union, UK The Committee for Human Medicinal Products plays a vital role in the Centralised Procedure and in handling referrals from the Mutual Recognition and Decentralised Procedure. This session will describe the CHMP work programme for 2010 as well as the projects that were successfully concluded from last year. The analysis of all Marketing Authorisation applications that were completed in 2009 will be discussed and key learnings highlighted. The Scientific Advisory Groups contribute in a significant way to the work of CHMP and their input to the overall success of the Centralised Procedure will be shared. CHMP – Its Achievements and Future Direction Eric Abadie, Chairman, CHMP, European Medicines Agency; General Directorate, Afssaps, France Developments in Interaction between CHMP and its Working Parties Xavier Luria, Head of Sector Safety and Efficacy of Medicines, European Medicines Agency, EU The Valuable Contribution of Scientific Advisory Groups Francisco Pignatti, Scientific Administrator, Safety and Efficacy of Medicines, European Medicines Agency, EU Wednesday, March 10, 2010 Theme 8 - Theme 9 09:00 Session 0806 DIALOGUE AND SCIENTIFIC ADVICE: ACHIEVING GOALS AND MAKING IT HAPPEN Session Chair: Chris Griffett, Vice President, Regulatory Affairs, Celgene, USA Effective dialogue between the regulators and the regulated in Europe has been shown to be a fundamental plank in designing programs for both the development of new medicines and enabling marketing approvals. This engagement with the Health Authorities enables them to reflect on specific requirements and on the other hand, provides the opportunity for companies to make the case for justifying any chosen path for development. Scientific Advice at the EU and/or national levels is fully encouraged. Dialogue has also driven strong debate in policy matters, impact assessment of new guidelines, proposed new rules, etc. In Europe we have an excellent track record. Many challenges remain. Health authorities strive for greater transparency. Globalisation looks to align development programmes which focus on efficiency and simultaneous submissions for clinical trials or marketing approvals in all regions. How then can we optimally ensure alignment around the globe? We have a great opportunity. The dialogue between health authority stakeholders around the world and Health Authorities aims at exposing divergence and driving alignment. How can this best be achieved? What opportunities can be exploited? At this session, we have invited speakers who have proven track records as opinion leaders in regulatory affairs. These will represent health Authority thinking as well as cutting edge industry know-how. We will explore options and evaluate ideas aimed at better strategic planning for dialogue and scientific advice in Europe, and in global context. View of the Health Authority at National and EU/CHMP Levels Gonzalo Calvo Rojas, Member of CHMP, Agency on Medicines Healthcare Products, Spain Presentation title to be confirmed Peter Lassoff, Vice President, Europe, PAREXEL Consulting, UK Panel with Spiros Vamvakas, Head of Scientific Advice, Technical Coordinator for ICH, European Medicines Agency, EU 11:00 Session 0407/0807 INFLUENCE OF HTA ON REGULATORY DECISION MAKING: REALITY? AN OPPORTUNITY? A THREAT? (JOINT SESSION WITH THEME 4) Session Chair: François Meyer, Director, Health Technology Assessment Division, HAS Haute Autorité de Santé, France Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Getting to the Right Evidence for Licensing and HTA Authorities at the Point of Launch: An achievable endpoint? Franz Pichler, Portfolio Manager, CMR International Institute for Regulatory Science, UK 14:00 Session 0808 SIMULTANEOUS GLOBAL DEVELOPMENT: PRESENT HURDLES, FUTURE CONSIDERATIONS AND OPPORTUNITIES Session Chair: Ian Laws, Vice President, Global Regulatory Affairs, Cardiovascular and Metabolic Diseases, GlaxoSmithKline, USA Given the current size and complexity of pharmaceutical development programmes, continued improvements to streamline the development of new and innovative medicines are critical. Despite significant operational challenges, the conduct of global studies which follow the same protocol across multiple regions, is considered by the innovative pharmaceutical industry as a very efficient approach to clinical development. This philosophy is in line with the drivers behind the creation of the International Conference for Harmonisation (ICH) guideline documents, including ICH E-5 (Ethnic Factors in the Acceptability of Foreign Clinical Data). However, despite very significant progress made with the implementation and acceptance of ICH guidelines, barriers to the conduct and acceptability of global development approaches still remain. This issue has been recognised as significant, not only by the pharmaceutical industry, but also by a number of governmental agencies, and efforts now exist to evaluate the challenges associated with the conduct of global studies. This session will review the current barriers, and with an emphasis on Asia, will look at practical steps being taken to facilitate both global development and acceptibility of these data in regional marketing applications. It will also review potential future issues and considerations. Henrietta Ukwu, Vice President, Global Regulatory Affairs, Wyeth Pharmaceuticals, USA Ulrich Taglieber, Chair, Simultaneous Global Development Committee, PhRMA, USA Ekopimo Ibia, Director, Global Medical and Regulatory Policy, Merck Research Laboratories, USA Theme 9 Risk Management Theme Leaders: Trevor Gibbs, Executive Vice President, ii4sm, Switzerland Brigitte Keller-Stanislawski, Head, Pharmacovigilance, Paul-Ehrlich-Institut, Germany Risk Management remains a topic on everyone’s agenda. This year, we will reflect on the implementation of regulations by the European Medicines Agency and FDA over the last few years, describe some of the major research initiatives in the area and provide practical working examples from industry and regulators. Above all, the theme will reflect the multi-disciplinary approach that is required
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. to create a clear picture of what we know, what we don’t know and how to address harm minimisation and benefit maximisation for patients and customers. Monday, March 08, 2010 16:30 Session 0601/0901 RISK MANAGEMENT FOR SWITCH PRODUCTS (JOINT SESSION WITH THEME 6) Session Chair: Andrew Rut, Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, UK This session will cover the challenges of taking prescription products to overthe-counter use at the European level and how these can be addressed with creative pharmacovigilance and risk management approaches. There is an increasing desire for making medicines available without a prescription and for patients to take greater responsibility for their health. The criteria that define a successful OTC switch will be discussed using data collected across key pharma/consumer companies, from a case study and from the perspectives of the European Regulatory authorities. Current and Optimal Approaches, Including Industry Perspectives for Innovative Switches Chris Holmes, Director, World Class International, UK A Case Study of Risk Management Planning for a Novel Switch: Orlistat Andrew Rut, Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, UK Regulatory Expectations of Risk Management Programmes for Innovative Switches Jan Petracek, Head of Risk Management, European Medicines Agency, EU Tuesday, March 09, 2010 09:00 Session 0902 REGULATORY DEVELOPMENTS IN RISK MANAGEMENT IN THE EU AND US Session Chair: Brigitte Keller-Stanislawski, Head, Pharmacovigilance, Paul-Ehrlich-Institut, Germany The objective of this session will be to provide an update of the implementation of risk management regulations by the European Medicines Agency and FDA over the last few years. In the EU there will be feedback from a project completed on the quality and completeness of risk management plans submitted by companies during the first two years of the new EU risk management legislation. Deficiencies in RMPs will be outlined and proposals for improvement as well as changes to current guidelines will be described. More generally there will be a draft outline of new legislation being proposed in the EU for the future in the context of risk management planning. An FDA representative will describe the latest developments at FDA and implementation of the FDAAA and REMS. A pharmaceutical industry representative will provide their company’s experience in meeting the differing risk management regulations in the EU and US. The session will be completed with a roundtable panel discussion on global risk management. Regulatory Update from the EU Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU Regulatory Update from the US FDA speaker invited Industry Update Jacques Mascaro, Senior Vice President, Global Regulatory Affairs, Pharmacovigilance and Quality, Elan Pharma International Ltd., Ireland Theme 9 - Theme 10 Panel discussion: Global Approach to Risk Management with speakers and Panos Tsintis, Medical Director, Choice Pharma, UK 11:00 Session 0903 NON-CLINICAL SUPPORT TO AID RISK MANAGEMENT IN EARLY PHASE STUDIES Session Chair: Phil Wilcox, Vice President, Non-Clinical Safety Projects, Safety Assessment, GlaxoSmithKline, UK This session looks at 3 different situations where non-clinical data are very important in managing safety risks in early clinical studies. The topics to be discussed include the selection of starting and stopping doses for Phase I studies (including exploratory clinical trials), managing compounds with an identified cardiovascular hazard, and how to progress compounds that have been shown to induce convulsions in non-clinical species. Use of Non-Clinical Data in Selecting Starting and Maximum Clinical Dose for Phase I Studies, and Dose Escalation Strategy David Jones, Expert Pharmacotoxicologist, MHRA, UK Integrated Non-clinical Cardiac Safety Assessment and Translational Biomarkers to Support the Design of Clinical Studies on Cardioactive Compounds Mark Holbrook, Executive Director, Global Safety Pharmacology, Pfizer, UK How to Manage Convulsion Risk Identified in Non-Clinical Species: Approach to early clinical studies Andrea Terron, Director of Neuroscience Projects, Safety Assessment, GlaxoSmithKline, Italy 14:00 Session 0904 WHEN DO ADVERSE EFFECTS QUALIFY AS UNDESIRED EFFECTS? Session Chair: Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany This session will review the challenges of evaluating a causal association of adverse drug effects in different scenarios during a product lifecycle and provide recommendations for decision making. Decision Making in Drug Safety: Science or prejudice, public health or politics, medical or medico-legal? Glyn Belcher, Vice President, Drug Safety and Risk Management International, Biogen Idec Ltd., UK The Tamiflu Example – What complete analysis can mean Barbara Donner, Safety Science Leader, F. Hoffmann-La Roche AG, Switzerland Decisions – Are they evidence based? Stephen Evans, Professor of Pharmacoepidemiology, The London School of Hygiene & Tropical Medicine, UK 16:00 Session 0905 RESEARCH AND INTERNATIONAL INITIATIVES IN RISK MANAGEMENT Session Chair: Panos Tsintis, Medical Director, Choice Pharma, UK The session will describe international research initiatives in the area of risk management. These will include the latest developments in methodologies for signal detection and data mining and feasibility of using electronic health records and large automated healthcare databases. Speakers will cover major initiatives undertaken by regulators (European Commission, European Medicines Agency, FDA), academia, CIOMS and public-private partnerships. Latest Developments in Signal Detection and Data Mining Stephen Evans, Professor of Pharmacoepidemiology, The London School of Hygiene & Tropical Medicine, UK 33
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