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

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38 Theme 12 - Theme 13 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Progress on the Creation of ICH Standards for Safety Reporting and Identification of Medicinal Products Andrew P. Marr, Director, Global eRegulatory Development, Global Regulatory Operations, GlaxoSmithKline, UK Emerging ICH Technical Standards for Safety & Identification of Medicinal Products Raun S. Kupiec, Senior Director, Regulatory Affairs, Genzyme Europe, The Netherlands Panel with Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk Management, European Medicines Agency, EU 11:00 Session 1107 UTILISATION OF ELECTRONIC MEDICAL RECORDS IN CLINICAL DEVELOPMENT Session Chair: Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France With the adoption of electronic Health Records throughout the world, their use for Clinical Research is increasingly attractive. Especially the areas of patient recruitment for clinical trials or the integration of electronic data capture within the hospital environment are being explored. This session contains several case studies exploring this new field. Utilisation of Electronic Medical Records in Clinical Development Joseph Kim, Director, Site Feasibility and Patient Recruitment, ePharmaSolutions, USA EHR Use for Recruiting Patients on Oncology Trials Marc Cuggia, Department of Medical Information, University Hospital of Rennes and INSERM, France Integration in a Hospital Environment Christel Daniel, Pathologist, Associate Professor, Hôpital Européen Georges Pompidou, INSERM, France 14:00 Session 1108 CONNECTING HEALTHCARE AND CLINICAL RESEARCH Session Chair: Philippe Verplancke, Managing Director, XClinical GmbH, Germany Healthcare and clinical research are intimately linked; however different work processes and information standards, as well as different regulatory environments make their integration challenging. In this session we will explore how we can make integration possible. Connecting Healthcare and Clinical Research - EHRCR Link Miguel A. Valenzuela, Head of Enterprise Systems QRM, Roche Products Ltd., UK Integration of Electronic Health Records (EHR) and Electronic Data Capture (EDC) Systems – A case study Wolfgang Summa, Executive Vice President, Business Development, OmniComm Systems, Germany Theme 12 Pharmaceutical Sciences in 2020 Theme Leaders: Geoff Tucker, Emeritus Professor of Clinical Pharmacology, University of Sheffield and UK Chairman, Simcyp Ltd., UK Hubert Leufkens, Professor Division of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Studies, The Netherlands The pharmaceutical sciences are likely to look very different in 10 years time. These sessions will peer into the crystal ball with respect to changes in research emphasis, enabling technology, paradigms for drug development, evaluation and regulation and the education of the workforce. Tuesday, March 09, 2010 09:00 Session 1202 WHAT MAJOR RESEARCH ACTIVITIES WILL DRIVE DRUG DISCOVERY AND DEVELOPMENT? Session Chair: Geoff Tucker, Emeritus Professor of Clinical Pharmacology, University of Sheffield and UK Chairman, Simcyp Ltd., UK By 2020, developments in target identification, systems biology, bioengineering and bioinformatics are likely to have transformed the pharmaceutical sciences. Perspectives will be provided from academia, industry and business development. Looking into the Academic Tea Leaves Malcolm Rowland, Emeritus Professor of Pharmaceutical Sciences, University of Manchester, UK What Will Tomorrow's Innovation Ecosystem Be for Biomedical R&D? Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline, UK 11:00 Session 1203 WHAT WILL THE ENABLING TECHNOLOGIES BE? Session Chair: Daan Crommelin, Scientific Director, Top Institute Pharma, The Netherlands Basic science provides us with a plethora of new insights that may be drivers for innovation in the pharmaceuticals sciences. One can think of: the impact on therapeutic handling of ultrafast computing, tissue engineering/stem cells, noninvasive imaging, on-demand delivery/miniaturisation of monitoring/delivery equipment, robotics, enhanced and pervasive information technology for sharing knowledge. In three presentations a selection of these drivers will be discussed. The Role of Computers in the Pharmaceutical Sciences 2020 Speaker invited Nanotechnology - Will the hope turn out to be hype? Daan Crommelin, Scientific Director, Top Institute Pharma, The Netherlands Advanced Technologies in 2009: What will have happened to them by 2020? Egbert Flory, Head of Tissue Engineering and Somatic Cell Therapeutics, Paul- Ehrlich-Institut, Germany Panel with Christian Schneider, Chair CAT, European Medicines Agency, Head, Division EU Cooperation/Microbiology, Paul-Ehrlich-Institut, Germany 14:00 Session 1204 WHAT PARADIGM/GEOGRAPHICAL SHIFTS WILL THERE BE IN DRUG DISCOVERY/DEVELOPMENT? Session Chair: Vinod Shah, Scientific Secretary, International Pharmaceutical Federation (FIP), USA By 2020 a number of balances are likely to undergo further change – small companies in favour of large companies for discovery, while clinical development and marketing development will remain the province of large companies; more biologicals relative to small molecules; an increasing component of metabolomics relative to genetics in the drive for personalised medicine; and eastward global drifts in the brain gain/drain ratio. Climate change is also likely to have a significant impact on the complexion of drug
discovery and development. This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Pharmaceutical Sciences 2020 – Medicines of the Future Vinod Shah, Scientific Secretary, International Pharmaceutical Federation (FIP), USA Pharmaceutical Sciences 2020 – Business Models of the Future Mario Rocci, Executive Vice President, Icon Development Solutions, USA The Prospective Contribution and the Global and Integrated Approach to Pharmaceutical Industry’s New Challenges Catherine Frade, Director, AxeLPharm, France 16:00 Session 1205 HOW WILL REGULATORS AND THE HTA COMMUNITY RECONCILE THE NEED FOR RAPID MARKET ACCESS WITH THE ASSESSMENT OF BENEFIT/RISK? Session Co-Chairs: Hubert Leufkens, Chairman of the Medicines Evaluation Board, The Netherlands Geoff Tucker, Emeritus Professor of Clinical Pharmacology, University of Sheffield and UK Chairman, Simcyp Ltd., UK There is growing awareness that granting a marketing authorisation for a new medicinal product is rather the beginning than the end in pharmaceutical innovation. First, a decision of approval is virtually always made under conditions of great uncertainty with respect to the benefit/risk of the product in real life practice; rapid access scenarios need post-approval studies to bridge this gap. Moreover, a new medicinal product will be increasingly subject to health technology assessment (HTA) in order to fuel evidence-based formulary and/or reimbursement decision making. This session will highlight the current scientific, regulatory and economic challenges and will address the various opportunities for collaboration and synergy between the different stakeholders. Is the Industry Ready to Embark on Rapid Access to New Medicines Scenarios? Ulf Janzon, Director External Affairs, Merck Sharp & Dohme, Sweden Rapid Access to New Medicines Given Uncertain Benefit/Risk from the HTA/Payers Perspective Albert Wertheimer, Director of the Center for Pharmaceutical Health Services Research at the School of Pharmacy, Temple University, USA Benefit/Risk Management throughout the Product Lifecycle as a Key to Sustainable Access to Medicines Hubert Leufkens, Chairman of the Medicines Evaluation Board, The Netherlands Wednesday, March 10, 2010 09:00 Session 1206 HOW WILL CHANGES IN EDUCATION MEET THE DEMANDS OF INDUSTRY AND REGULATION? Session Chair: Lyle Bootman, Dean and Professor, College of Pharmacy, University of Arizona, USA An overview of the reform of healthcare delivery reform that is occurring in the USA and globally will be followed by an assessment of the how this will impact educational needs and demands of academia (science and practice), industry and regulation to meet this paradigm shift at undergraduate, graduate and professional levels. Impact of Health Reform on Pharmacy Education Lyle Bootman, Dean and Professor, College of Pharmacy, University of Arizona, USA Theme 13 Changes in Pharmaceutical Sciences Education: Needs and demands from Academia and Industry Jonathan Cooke, Director of Research and Development, Clinical Director for Medicines Management and Pharmacy, University Hospital South Manchester, UK Training for the Future: A Regulatory Perspective on the Future of Professional Education Gro Wesenberg, Director Medical Department, Medicines Agency, Norway Theme 13 Clinical Trials and e-Submissions Theme Leaders: Bruno Flamion, Chair Scientific Advice Working Party (SAWP), CHMP; Professor Clinical Pharmacology, University of Namur, Belgium Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, Pfizer AB, Sweden This theme differs from the other themes in that it does not take a multidisciplinary view of a certain area. When developing the programme, it was noticed that a number of aspects related to clinical trials as well as to esubmissions would be of interest to cover and would thus merit inclusion, however not falling within any of the defined themes. Theme 13 is hence a mix of topics related to clinical trials and to e-submissions. The aim has been to capture aspects that might benefit a broader audience. Tuesday, March 09, 2010 09:00 Session 1302 IS THE EUROPEAN APPROACH TO IMPLEMENTATION OF THE ICH-GCP STANDARD KILLING CLINICAL RESEARCH? Session Chair: Ingrid Klingmann, Managing Director, Pharmaplex bvba, Belgium ICH-GCP was introduced 13 years ago with the intention to protect patients in clinical trials and to ensure acceptable quality standards in the global development of new treatments. The resulting European legislative framework for clinical trials combined the implementation of the GCP principles with the introduction of a system to harmonise the clinical trial performance in the EU Member States and to increase transparency in clinical research. In addition, national legislation, ethics committees and commercial sponsors felt obliged to further strengthen the adherence to these principles – everyone with own ideas and own rules. As a result, investigators are confronted with a flood of administrative requirements, different systems and approaches, minimising their capacity to recruit and retain patients in clinical trials or to organise most needed, scientifically sound treatment optimisation studies that are of no interest to the pharmaceutical industry. But also ethics committees and (especially) smaller Pharma companies feel unable to work at their best capability in the patients’ interest. It is high time to streamline the current European clinical trial process, to reduce duplication of efforts and to clarify distribution of responsibilities. This session will highlight the most critical areas and present solutions. Is the Current European Ethical Review Process Really in the Patients’ Best Interest? Jan Geissler, Executive Director and co-founder, European Cancer Patient Coalition (ECPC), Germany Does the Current Safety Reporting System in Clinical Trials Reduce Patients’ Risks in Clinical Trials? Nathalie Dubois, Head of Pharmacovigilance Unit, EORTC, Belgium Reduction of Bureaucracy in Clinical Trials – A proposal to rescue clinical research in Europe Ingrid Klingmann, Managing Director, Pharmaplex, Belgium 39
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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