EuroMEEting - Genetic Alliance UK

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36 THEME 12 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Quality System Requirements for a Medical Device Company Dirk Wetzel, Head of the Medical Devices Division, BfArM, Germany 14:00-15:30 Session 1107 CLINICAL DEVELOPMENT OF MEDICAL DEVICES Session Chair: Danielle Giroud, Founder, World Medical Device Organisation, Switzerland Clinical Aspects of EU Medical Device Directives MDD 93/42/EEC and 2007/47/EC Danielle Giroud, Founder, World Medical Device Organisation, Switzerland Navigating ICH E6 GCP or ISO 14155 for your Combination Product Matthew J. Tarosky, Deputy Director, Division of Bioresearch Monitoring, Office of Compliance FDA, USA Notified Body Expectations for Clinical Evaluation of Medical Devices Christian Schübel, TüV Süd Product Service GmbH, Germany Theme 12 | Drug Development in the Real World Philippa Smit-Marshall, Vice President Medical and Scientific Affairs, PharmaNet B.V., The Netherlands Ineke Rijnhout, Consultant, Kenko International, The Netherlands This theme will address current issues in global drug development that face innovators and licensees. Have the recent changes in the industry structure with recent mergers and divestment of unwanted drug portfolios had an effect on strategies adopted to get products to market? Moreover, new regulatory challenges and revisions require not only compliance with requirements but also long term post marketing commitments and demand innovative approaches to the global approval process. Achieving quality and effective clinical study conduct determines product competitiveness. Tactics to improve operational achievements, partnering with service providers and the utilisation of emerging territories to recruit sufficient patients on time will be discussed. The increasing influence of patients or patient organisations in clinical research is a phenomenon that will be addressed. Tuesday, 29 March 2011 09:00-10:30 Session 1201 EFFECTIVE GLOBAL CLINICAL DEVELOPMENT: FUTURE TRENDS Session Chair: Philippa Smit-Marshall, Vice President Medical and Scientific Affairs, PharmaNet B.V., The Netherlands This session focuses on some of the current drivers for drug development including the economics of the pharmaceutical industry and clinical disease state modelling. Techniques used to derive information on the most appropriate strategy for conducting clinical research such as data mining techniques will be covered to indicate some of the more innovative techniques to ensure clinical development success. Economic Trends in the Pharma Industry: Drivers of medicines development Speaker invited Clinical Disease State Modelling: Personalised Medicine Michael N. Liebman, President/Managing Director, Strategic Medicine, Inc. USA Analysing Contemporary Clinical Trial Activity and Matching with Global Trends: The value of data mining David Cocker, MDC Partners, Belgium 11:00-12:30 Session 1202 COST REDUCTION STRATEGIES IN CLINICAL TRIAL CONDUCT Session Chair: Nermeen Varawalla, President & CEO, ECCRO, UK The imperative to contain the costs of clinical trial conduct is more than ever before. Eliminating the inefficiencies in stakeholder liaison could universally save costs. Best practices in managing CROs, study planning and setting up contracts with clinical trial sites will be shared followed by a discussion of the implementation of these practices. Cost Reduction during the CRO/Sponsor Interface Rikke Winther, Divisional Director, Outsourcing Management, H. Lundbeck A/S, Denmark Reducing Clinical Trial Costs while Maintaining Study achievability: Case studies Melinda Davis, Director, Clinical Services, Clear Trial, USA The Impact of Legal and Contract Process on Clinical Trial Costs and Efficiencies Myrthe Rijswijk-Trompert, Independent Consultant, The Netherlands 14:00-15:30 Session 1203 POST-APPROVAL STRATEGIES Session Chair: Jens Reinhold, Head GMA-NIS, Bayer Schering Pharma AG, Germany This session will focus on strategies to maintain product lifecycle and focus on the importance of post-approval research and strategies to ensure rapid approvals to maximise effective patent life on a global basis. When to Start Thinking about Peri-Approval Strategies Jens Reinhold, Head GMA-NIS, Bayer Schering Pharma AG, Germany Develop Globally - Like it or not Nancy Meyerson Hess, Director of Business Development, Harrison Clinical Research, Germany Post -Approval Strategies and Changes to Reduce Lead Time for Worldwide Approvals Lone Eskilden, Manager, Novo Nordisk A/S, Denmark 16:00-17:30 Session 1204 PATIENTS: AN INCREASINGLY INFLUENTIAL VOICE IN DRUG DEVELOPMENT Session Chair: Philippa Smit-Marshall, Vice President Medical and Scientific Affairs, PharmaNet B.V., The Netherlands Patients are important participants in clinical studies and are endpoint users of marketed products with unique expectations. Their voice in how clinical research should be conducted, from their perspective as trial participants, is important and their needs and expectations should be addressed in terms of good clinical practice and setting priorities for medicines development but also in the provision of information on marketed products. Additionally, guardians of vulnerable patient populations such as the elderly and paediatric
THEME 12 | THEME 13 37 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. subjects are instrumental to the success of clinical research and should be active partners in the drug development process. Enlightened Patient: Pharma customer expectations in the 2010s Juha-Matti Saario, SOP Governance Officer, Novartis Pharma AG, Switzerland Moving Beyond the Agency Interaction: Involving patients in drug development Anders Blaedel Lassen, Reg. Int. & Pol. Specialist, H. Lundbeck, Denmark Patient representative invited Wednesday, 30 March 2011 09:00-10:30 Session 1205 PARTNERING IN DRUG DEVELOPMENT Session Chair: Ineke Rijnhout, Consultant, Kenko International, The Netherlands Nearly half of today’s top-selling drugs in the pharmaceutical industry are the result of partnerships. The pressure to maintain strong portfolios underscores the importance of alliance management. Last year, in the depths of the financial crisis, many companies took drastic restructuring measures, bringing focus and creativity to the efficiency-related challenges. The key driver for survival is their ability to find ways to operate drug development more effectively. What creative partnering structures approaches are companies using in today’s challenging times? A New Model for Developing CRO Partnership: Project Nemo Frederic Monnot, Clinical Research Manager, Merck Serono, Switzerland CRO Pharma Partnership Example Speaker invited Biotech/Pharma Partnering Speaker invited 14:00-15:30 Session 1207 HEALTH ORGANISATIONS AND THEIR INFLUENCE ON DRUG DEVELOPMENT Session Chair: Richard Laing, Team Leader, Medicine Information and Evidence for Policy, Department of Essential Medicines and Pharmaceutical Policies, WHO, Switzerland Health Organisations play an important role in identifying the health needs of the global population and are instrumental in defining development strategies and access to safe medicines. One such organisation is the WHO. Other important areas are neglected diseases and orphan indications, where financial considerations and the logistical aspects of conducting clinical research in these populations may be important hurdles and play an important role in setting development priorities. The emergence of herbal medicines as a therapeutic intervention is increasing and the appropriate regulation of their manufacture and clinical development will be discussed. The Role of the WHO in Setting Drug Priorities Speaker invited Neglected Disease and Orphan Medicines Johan Frieling, Independent Consultant, The Netherlands The Importance of Herbal Medicines as a Therapeutic Class - How to conduct clinical research and regulate their development Speaker invited 16:00-17:30 Session 1208 INVESTIGATOR-LED CLINICAL DRUG DEVELOPMENT Session Chair: Xavier Carné, Head of Clinical Pharmacology Department, Hospital Clinic, University of Barcelona School of Medicine, Spain Prior to the introduction of the European Clinical Trial Directive, investigator led clinical development played a prominent role in medicines development. In some settings this is still the case and academic sites regain their influence on defining priorities for medicines based on the latest scientific advances. Speaker from academia and investigator networks will address the challenges ensuring that data generated from investigator led research is of the highest quality and is appropriate to support drug registration. Investigator-Led Research: Experience of the Medicines for Children Reasearch Network Nicholas Webb, Royal Manchester Children’s Hospital, UK Investigator Initiated Trials (IIT) – State of the industry and the need for global standards and metrics Ran Frenkel, CEO, Pharma Focus, Israel Theme 13 | Biologicals and Vaccines – Access to Innovation Thomas Verstraeten, Head Biologicals Clinical Safety & Pharmacovigilance, GlaxoSmithKline Biologicals, Belgium Michael Pfleiderer, Head of Section, Viral Vaccines, Paul-Erhlich-Institut (PEI), Germany This theme will focus on a number of areas specific to biologicals and vaccines. As well as looking to see what impact recent changes to the EU legislation have had, this theme will provide time to discuss and share new developments and advances that have and will be seen in the area of biologicals and vaccines. And finally, perhaps a slight departure from the other topics under this theme, there will be a session to allow reflection on the public perception of medicine and in particular the public perception of vaccines and vaccination programmes. Tuesday, 29 March 2011 09:00-10:30 Session 1301 PHARMACOVIGILANCE FOR BIOLOGICALS AND VACCINES Session Chair: Phil Bryan, Expert Scientific Assessor, MHRA, UK This session will outline recent examples of potential quality issues for authorised vaccines, describe the systems in place to identify and evaluate the potential clinical implications and risks and to discuss processes for traceability, recall and implications for immunisation programmes. It will also aim to explore ways in which systems and processes can be improved to optimise risk management of vaccines in this context.
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