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

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30 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 14:00 Session 0704 BIOMARKER QUALIFICATION PROCESS - HOW DOES IT WORK AND WHERE DOES IT FIT? Session Chair: Yoshiaki Uyama, Review Director, Office of New Drug III, PMDA, Japan The European Medicines Agency’s new procedure on biomarker qualification is a crucial new element in supporting the development of personalised medicines. How does it work, when should we use it, what can we expect and where does it fit in with other systems? The New Biomarker Qualification Process – What to expect and how does it work? How does it fit together with Scientific Advice? Bruno Flamion, Chair Scientific Advice Working Party (SAWP), CHMP; Professor Clinical Pharmacology, University of Namur, Belgium Biomarker Qualification - When to use it and why. An Industry View Duncan McHale, Vice President, Translational Sciences, DECS, AstraZeneca, UK Strategic Pathways for Biomarker Qualification Lawrence J. Lesko, Director, Office of Clinical Pharmacology and Biopharmaceutics, OTS, CDER, FDA, USA 16:00 Session 0705 EFFICACY: EVIDENCE AND STUDY DESIGNS IN PERSONALISED MEDICINES Session Chair: Bruno Flamion, Chair Scientific Advice Working Party (SAWP), CHMP; Professor Clinical Pharmacology, University of Namur, Belgium Developing a targeted therapy requires different elements and approaches from the traditional development programmes. What needs to be addressed in the clinical trials and development frameworks for a successful outcome? What can we learn from experience to date and what are the appropriate directions for the future? Individualisation of Medical Treatment: Design and Strength of Evidence Issues in Pharmacogenomics Clinical Trials Sue-Jane Wang, Associate Director, Adaptive Design & Pharmacogenomics/Pharmacogenetics, OB, OTS, CDER, FDA, USA Exploratory Pharmacogenetic Analysis of Efalizumab Responders Emmanuel Monnet, Head of Biomarkers - Neurology and Autoimmune Diseases, Merck Serono International S.A., Switzerland Back to the Basics: Capitalising on Novel Approaches for Establishing Prospective Diagnostics in Clinical Oncology Development Jennifer Weidman, Senior Director, Research and Development, Cancer Advances, Inc., USA Wednesday, March 10, 2010 Theme 7 - Theme 8 09:00 Session 0706 SAFETY: EVIDENCE AND STUDY DESIGNS IN PERSONALISED MEDICINES Session Chair: Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU A personalised medicine approach can be developed “upfront”, or it can be developed post-authorisation. This session will explore methodologies and case studies in the field of post-authorisation targeting of therapies. What are the hurdles and how can the increasing understanding of and information about the product be passed effectively to the people who need it? Principles of Clinical Study Design for Biomarkers and Co-Diagnostics Jeffrey Bojar, Vice President of Legal and Regulatory Affairs, Biodesix, Inc., USA Drug Plasma Levels and Adverse Drug Reactions: Usefulness of the TDMplus algorithm Jan Willem van der Velden, Director, Mesama Consulting, Switzerland 11:00 Session 0707 DIAGNOSTICS – IF THIS IS SUCH A CRUCIAL ELEMENT OF THE WHOLE FIELD, WHAT ARE WE DOING TO SUPPORT, ENCOURAGE AND PROTECT THE DIAGNOSTICS FIELD? Session Chair: Georgette Lalis, Director ENTR/F, European Commission, EU This session will explore the balance between public health and the need to have a diagnostics industry with a meaningful business model. Diagnostics - Regulatory and legal incentives for development and what can be improved Peter Bogaert, Managing Partner, Covington and Burling LLP, Belgium The Value of Diagnostics James Creeden, Head of Medical Affairs, Roche Diagnostics Ltd., Switzerland A Practical View of Medicine-Diagnostics Co-Development – An SME perspective Tim Kievits, CEO, Pamgene, The Netherlands Panel with Mary Baker, MBE, President of European Federation of Neurological Associations (EFNA), UK 14:00 Session 0708 INTERNATIONAL REGULATORY FRAMEWORKS – CONVERGING OR DIVERGING? A PANEL DISCUSSION Session Chair: Emer Cooke, International Liaison Officer, European Medicines Agency, EU Regulatory representatives from three main regions will give an overview of the status in their regions, highlight issues and provide suggested potential solutions before moving to an open panel discussion with a leading industry representative. Marisa Papaluca-Amati, Head of Scientific Support and Projects, European Medicines Agency, EU Lawrence J. Lesko, Director, Office of Clinical Pharmacology and Biopharmaceutics, OTS, CDER Yoshiaki Uyama, Review Director, Office of New Drug III, PMDA, Japan Theme 8 Taking the European Regulatory Infrastructure Forward Theme Leaders: Brenton James, Consultant in Strategic Regulatory Affairs in the European Union, UK Thomas Kühler, Thomas Kühler, Regulatory Affairs Specialist, Sweden This theme will address many issues concerning the procedure of gaining regulatory approval and market access for medicinal products in Europe. The European Commission has set out both a communication and several legislative proposals on patient information, counterfeit medicines and pharmacovigilance. This is draft legislation that will go via the co-decision procedure through the Council and the European Parliament. The European Medicines Agency is changing to be able to handle the additional responsibilities of Advanced Therapies and the changing nature of the types of marketing applications that are being filed in the Centralised Procedure. As the CHMP plays a pivotal role at the European Medicines Agency, its role and objectives will be described and a survey of all applications in 2008 will provide key learning points for development of medicinal products. The European Medicines Agency sets out its strategic vision in the publication of Road Maps. The success of the Road Map to 2010 and the map for the next five years will give an understanding of the direction the Agency will follow. As a complement
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 the Agency’s Road Maps, the Heads of Agencies released their Strategy Paper setting out the ambition for National Competent Authorities in the future. Stakeholders are interested in the resources that are available to support the Decentralised and Mutual Recognition Procedure and how they will be allocated. Industry sees much to gain in a dialogue with regulators. Ways that dialogue may be enhanced to the benefit of both industry and Agencies will be explored so that creative suggestions can be offered for further discussion. Recognising that the approval of a marketing application is the first step to the availability to patients of a medicine, the vital role and contribution of Health Technology Assessment bodies will be presented so that the interaction between the two organisations can be understood by stakeholders. Europe is one of the three major pharmaceutical markets in the world and cooperation between regulatory agencies in these countries and others are important for public health. Monday, March 08, 2010 16:30 Session 0801 PHARMACEUTICAL PACKAGE - THE LATEST INFORMATION Session Chair: Truus Janse-de Hoog, Staff member MEB, European Cluster, Chair CMD(h), Medicines Evaluation Board, The Netherlands The European Commission adopted three legislative proposals in December 2008: “The Pharmaceutical Package”. The aim of the package: • to tackle the growing issue of counterfeiting and illegal distribution of medicines • to better protect patients by strengthening the EU system for safety monitoring of medicines • to enable citizens to get high quality information on prescription-only medicines. The legal proposals are being discussed at the Council Working Party on Pharmaceuticals and Medical Devices and also in the European Parliament (EP). A representative from the European Commission and the Council Working Party will give an update on the current status. What are the main points for discussion and what is the expected timeframe for discussion? A representative from industry will present their view on the legislative proposals. European Commission Perspective Martin Terberger, Head of Pharmaceuticals Unit, DG Enterprise and Industry, European Commission, EU The Pharmaceutical Package: An update from discussions in the Council Working Party Johan Lindberg, Deputy Director, Ministry of Health and Social Affairs, Sweden The Pharmaceutical Package: A view from the industry Meni Styliadou, Head, European Public Affairs, Novartis, Belgium Tuesday, March 09, 2010 09:00 Session 0802 INTERNATIONAL COOPERATION AMONG REGULATORY AGENCIES Session Chair: Marie A. Dray, President, International Regulatory Affairs Group LLC, USA For the last few years, reports on privileged discussions among regulators on topics such as Regulatory Simplification under the auspices of the Transatlantic Dialogue, have been provided publicly at DIA Annual and EuroMeetings. This session will update the audience, to the extent not limited by confidentiality, on the current status of bilateral discussions between the EU/ European Medicines Agency and the US FDA on Regulatory Simplification and Theme 8 other current topics. In addition, a spokesperson for the ICH (International Conference on Harmonisation) will be invited to report on the status of communications under the ICH umbrella and the future of ICH. Finally, each speaker will be invited to answer candid questions from the audience on topics presented, as well as on related regulatory topics which might have been reported, elsewhere. European Medicines Agency Perspectives on Regulatory Cooperation and Communications Thomas Lönngren, Executive Director, European Medicines Agency, EU FDA’s Views on Continued Cooperation among Regulatory Authorities, under the New US Administration Murray Lumpkin, Deputy Commissioner, International and Special Programs, OC, FDA, USA The Value and Benefit of the ICH to Regulators—The CTD, the Common Regulatory Language Justina A. Molzon, Associate Director for International Programs, CDER, FDA, USA 11:00 Session 0803 HEADS OF MEDICINES AGENCIES Session Chair: Craig McCarthy, Managing Director, CAMPHARM, France This session will focus on the HMA strategy paper and some topical regulatory challenges and initiatives that the HMA are pursuing as part of their strategy. The speakers in this session, who are key leaders of their respective national regulatory agencies, will outline some of the challenges from this decade and initiatives for the next decade in the development of this strategy. HMA Strategy Paper Kent Woods, Chief Executive, MHRA, UK HMA Initiatives on Clinical Trials Jean Marimbert, Director General, Afssaps, France HMA Initiatives on Resourcing Jytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark 14:00 Session 0804 CHANGES IN REGULATORY AGENCIES TO MEET FUTURE CHALLENGES Session Chair: Thomas Kühler, Regulatory Affairs Specialist, Sweden The regulatory landscape is under constant change as agency workload is ever increasing and new scientific committees are created. Additional pieces of legislation are put in place, the different marketing authorisation procedures are extensively used and new work-bits, funded or not, are emerging. This session will focus on the relationship between the different scientific committees, how the work content is transformed and measures taken by regulatory agencies to cope with these changes. The session will also explore what Industry’s expectations on the agencies in those resource-demanding times are. Architecture of European Medicines Agency Scientific Committees and their relationship with National Agencies – the Commission Perspective Martin Terberger, Head of Pharmaceuticals Unit, European Commission, EU Swissmedic’s Reorganisation: Mission Accomplished? Cordula Landgraf, Head of Networking, Swissmedic, Switzerland What Industry Wants from Regulatory Authorities Julian Thompson, Vice President, Worldwide Regulatory Strategy, Pfizer Ltd., UK 31
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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