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

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20 Theme 2 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Ready, Fire, Aim? An update on the ever-changing global legislation related to clinical trial disclosure Jacqueline Sayers, Quality Projects Manager, Pharma Development Quality, Roche Products Ltd., UK Limitations and Challenges of Current Registries and Results Repositories Frauke Naumann, Clinical Assessor, Oncology Licensing Unit, BfArM, Germany Transparency beyond Registries: A concept for a clinical trials commons Greg Koski, Associate Professor of Anesthesia, Massachusetts General Hospital Partners Healthcare System, USA Panel with Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, Switzerland Tuesday, March 09, 2010 09:00 Session 0202 THE PRICE OF GLOBALISATION: BRINGING MODERN THERAPIES TO DEVELOPING COUNTRIES OR ONLY INCLUDING PATIENTS IN TRIALS? WHAT SHOULD WE ALL KNOW ABOUT INDIAN SOCIETY, MEDICAL PRACTICE AND PATIENTS BEFORE DRAWING CONCLUSIONS? Session Chair: Shirish Dattatraya Sherlekar, Practice Head, Life Sciences, Tata Consultancy Services, Ltd., India Indian Society and Medical Care Shirish Dattatraya Sherlekar, Practice Head, Life Sciences, Tata Consultancy Services, Ltd., India Risk Evaluation and Mitigation Strategies - Outcome of a survey on clinical trials in India Kurt Pfister, CEO, PFC Pharma Focus AG, Switzerland Engaging India: Borrowing from APEC and China Mark Paxton, Associate Vice President, International Regulatory Affairs, PhRMA, USA 11:00 Session 0203 THE PRICE OF GLOBALISATION: THE COSTS, BENEFITS, RISKS AND PITFALLS WHEN MOVING DEVELOPMENT AND MANUFACTURING TO LATIN AMERICA Session Chair: Sergio Guerrero, Director, OCA Hospital/Monterrey International Research Center, Mexico Emerging markets, such as Latin America, are now significant players in the global pharmaceutical industry. Economic and demographic growth has combined with changing disease profiles to present attractive new consumer markets as well as potential research and development locations. Latin America offers the opportunity to test on a wide variety of diseases that affect both developing regions as well as Western countries. As a whole, the region comprises 20 countries and over 560 million people, largely condensed around mega-cities with populations in excess of 10 or 20 million. The pharmaceutical and biotechnology industry has consolidated its presence in Latin America over the last decade, and today all the large multinational companies are reestablishing their presence outweighing the challenges. Emerging markets are unsurprisingly expected to grow at a much healthier rate, with the seven "pharmerging" regions of China, Brazil, Mexico, South Korea, India, Turkey and Russia expected to grow in importance. In this session we will provide you with the insight of industry experts related to the requirements for conducting qualified API GMP audits e.g., in India or China, and if this structure could be useful for the industry. On the other hand we will discuss the trend of the international US FDA inspections among the emerging markets pertaining to medical devices and device combination products, and where the FDA has a presence. Current and Future Requirements for Qualifying the GMP Compliance of API Manufacturers Stefan Kettelhoit, Managing Director, Blue Inspection Body GmbH, Germany The US FDA Medical Device and Device-Drug Combination Product Inspection Experience in Emerging Markets Lester B. Lacorte, FDA Medical Officer - Commissioner's Fellow, FDA, USA Clinical Development of New Drugs in Brazil: Opportunities and benefits João Massud, Executive Director/CEO, Newco Trials, Brazil 14:00 Session 0204 COUNTERFEITING: WHO OWNS THE PROBLEM? WHO IS IN CONTROL? Session Chair: Yves Juillet, Senior Advisor, LEEM, France Drug counterfeiting is a public health threat. The EU legislative proposal as well as technology projects like the Data Matrix 2D pilot study is making progress. In this session an update of this necessary coordinated fight against counterfeiting will be presented. Counterfeiting: A necessary fight Silvia Fritz, International DRA Manager, F. Hoffmann-La Roche AG, Switzerland Update on the EU Legislative Proposal Christer Backman, EU Coordinator Scientific and Regulatory Strategy, Medical Products Agency, Sweden Track and Trace: The results of Data Matrix 2D pilot study in Sweden Jean-Marc Bobee, Director Anti-Counterfeiting Strategy, Department of Strategy and Information Industrial Affairs, sanofi-aventis, France The Role of the Pharmaceutical Industry in Tomorrow’s Coordinated Fight against the Counterfeiting of Medicines Julie Maréchal, Senior Manager, Regulatory Affairs, EGA, Belgium 16:00 Session 0205 MISUSE OF MEDICINES AND DOPING: WHAT IS THE PROBLEM, HOW BIG IS THE PROBLEM? Session Chair: Olivier Rabin, Science Director, WADA, Canada Doping is considered to be the most important threat to modern sport. The World Anti-Doping Agency (WADA) was created by the governments of the world and by the sport movement to globally promote, coordinate, and monitor the fight against doping in sport in all its forms. Collaborations between the pharmaceutical industry has allowed the development of anti-doping tests and consequently prevented the athlete from misusing or abusing new drugs for the purpose of performance enhancement. The example of the successful collaboration between Roche and WADA for the detection of Mircera will be presented. Globalisation of such collaborative mechanism is being discussed with the industry. The public authorities are also an essential partner in the fight against doping in sport. The role and expectations of the public authorities will be presented with the particular perspective on the collaboration between the pharmaceutical industry and the anti-doping authorities. Introduction to the Problem of Doping in Sport and Society - WADA’s role Olivier Rabin, Science Director, World Anti-Doping Agency (WADA), Canada Rising to the Challenge – How a sponsor is tackling doping abuse Barbara Leishman, Clinical Science Leader, F. Hoffmann-La Roche AG, Switzerland Working Together in the Fight against Doping: French collaboration between public authorities and pharmaceutical industry, towards a European approach Jean-Marc Julien, Pharmacist, French Ministry for Health and Sport, France
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Wednesday, March 10, 2010 09:00 Session 0206 QUALITY RISK MANAGEMENT: MYTH, PROMISE OR A SOLUTION TO THE OPERATIONAL CHALLENGES OF CLINICAL DEVELOPMENT AND REGULATORY COMPLIANCE? Session Chair: Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany Acknowledging the costly and time-consuming quality management measures that sponsors, CROs, vendors and other service providers respectively take to reach compliance with GCP, the extent of findings, frequently identified by European GCP inspectors during inspections, indicate that the current approach to clinical quality management frequently fails to achieve the required quality standards. Sponsors are expected to cope with this challenge and to move towards a more systematic and holistic approach. This session will give an insight into what Health Authorities expect from risk-based quality management, what progress has been made by Pharmaceutical Companies implementing QRM and what academic sponsors think of all of this. Risk-Based Quality Management of Clinical Trials - An inspector view Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany Risk Analysis and Risk-Based Quality Management in Non-Commercial Clinical Trials Oana Brosteanu, Coordination Centre for Clinical Trials Leipzig, Germany Preventing Investigator Fraud and Non-Compliance Kenneth A. Getz, Senior Research Fellow, Center for the Study of Drug Development, Tufts University; Chairman, CISCRP, USA Panel Discussion: What Was Accomplished and What Have We Learnt? Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, Switzerland 11:00 Session 0207 NEW EFFORTS TO IMPROVE QUALITY AND EFFICIENCY IN CLINICAL DEVELOPMENT Session Chair: Raffael Jovine, Vice President and Global Head of Business Development and Head for Stakeholder Engagement, ii4sm, Switzerland CTTI: Challenging dogma, changing research practice Martin Landray, Reader in Epidemiology, Clinical Trial Service Unit, University of Oxford, UK Risk Based Contracted Services Relationship Model Siegfried Schmitt, Principal Consultant, PAREXEL, UK A New Model and Approach to Share and Leverage Compliance and Quality Information Beat Widler, Global Head, Clinical Quality Assurance, F. Hoffman-La Roche AG, Switzerland Panel discussion with Leslie Ball, Director, Division of Scientific Investigations, Office of Compliance, CDER FDA, USA, Gabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany, Fergus Sweeney, Head of Compliance and Inspections, European Medicines Agency, EU 14:00 Session 0208 GOVERNANCE CHALLENGES WHEN MANAGING PARTNERS SUCH AS CROs AND LICENSING PARTNERS Session Chair: Janis Little, Senior Director, Development Quality & Compliance, Genentech Inc., USA Risk-Based Contracted Services Relationship Model Siegfried Schmitt, Principal Consultant, PAREXEL, UK Theme 2 - Theme 3 Pharmacovigilance in Licensing Situations Christine Benert, PV Contract Management, Bayer Schering Pharma AG, Germany FDA View David A. Lepay, Senior Advisor for Clinical Science, Science and Health Coordination, OC, FDA, USA Theme 3 Paediatric Medicines on their Way to Patients Theme Leaders: Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp and Dohme (Europe) Inc., Belgium Thomas Severin, Medical Scientific Expert, Novartis Pharma AG, Switzerland The Paediatric Theme at the 22nd DIA EuroMeeting will reflect on opportunities and current challenges of paediatric drug development. The new Paediatric Legislation was established in Europe over 3 years ago and some early stocktaking can already be made: The impact of the new framework is multidimensional and touches on many aspects of new product development and lifecycle management. Regulators and Industry are discussing the adequate implementation of the new requirements and are negotiating Paediatric Investigation Plans. The overall goal is to meet the needs of children in many therapeutic areas whilst delivering the best possible safety protection for the population. Researchers and industry are collaborating to set up the necessary infrastructure to conduct numerous paediatric studies within a global R&D scope. They define new uniform standards as well as clinical and non-clinical methodologies to overcome the various challenges in the unique paediatric environment. Better and more innovative paediatric formulations are needed to address the selective preferences of children and enable good compliance with a treatment for optimal outcomes. Involvement of patent attorneys and lawyers is recommended for the development of a strategy to claim and achieve the deserved benefits in compensation for undertaking the additional research investments. A preliminary assessment of the positive impact on public health in balance with required resources will be made. Monday, March 08, 2010 16:30 Session 0301 REGULATORY CHALLENGES AND EXPERIENCE WITH NEW PAEDIATRIC REQUIREMENTS Session Chair: Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp and Dohme (Europe) Inc., Belgium In this session experts will share their experiences with the regulatory requirements and their interpretations under the Paediatric Regulation. Participants will learn more about the European Medicines Agency Paediatric Committee’s (PDCO) evaluation and decision criteria related to the PIP scope to be able to factor those aspects into their regulatory strategy development. Specific case studies illustrating the challenges of regulatory input from different bodies, authorities and regions during the global paediatric development and their impact will be presented. Specifically, the impact of the global marketing authorisation concept for Article 8 PIPs and the access to incentives related to orphan drugs will be discussed. Major inconsistencies caused by interpretation of several provisions of the regulation and their impact on industry will be highlighted and constructive suggestions for improvements presented. PDCO Experience, Evaluation and Decision Criteria Daniel Brasseur, Chair PDCO, European Medicines Agency, EU, Senior Member, Federal Drug Agency, Belgium Challenges for Manufacturers of Orphan Medicinal and PIP Case Studies Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs & Scientific Communication, Switzerland 21
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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