EuroMEEting - Genetic Alliance UK

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24 THEME 5 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Theme 5 | Wider Access (Generics/Switching) Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, Belgium How can we meet the patients' need and expectations? This question will be analysed for generics and self-care medicine. The efficiency of the existing regulatory system (licensing procedures, handling of the lifecycle, switchprocedures) will be discussed. Pros and cons will be identified in order to optimise access to medicines - also in developing countries – as well as affordable treatment by generics and biosimilars; with a high level of information to patients and consumers, which is especially important for nonprescription medicines. The impact of the new changes in the pharmaceutical landscape – a new Directorate General (DG), a new European Commissioner, new strategic roadmaps as well as new pieces of legislation – will be elucidated. Tuesday, 29 March 2011 09:00-10:30 Session 0501 SWITCHING: IS THERE AN IDEAL ROUTE? Session Chair: Hubertus Cranz, Director-General, AESGP, Belgium This session will review the existing procedures (CP, DCP-MRP, national) that can be used to switch a medicine, the conditions to be met and their pros and cons in terms of resulting access, resources needed etc. What are the influencing factors companies consider when choosing their ‘switching pathway’ and what would be needed to make it the 'perfect route(s)'. These views will be confronted with that of the authorities at national and EU level. The Centralised Procedure and Switch Eric Abadie, Chair, CHMP, Chair Pharmacogenomics Working Party, European Medicines Agency; General Directorate, Afssaps, France View of a National Authority June Raine, Director, Division of Vigilance Risk Management of Medicines, MHRA, UK What are the Important Factors when Selecting a Procedure? Speaker invited 11:00-12:30 Session 0502 ARE NEW SWITCHES IN LINE WITH THE EXPECTATION OF THE 'EMPOWERED PATIENT'? Session Chair: Anthony Humphreys, Head of Regulatory, Procedural and Committee Support, European Medicines Agency, EU A number of new switches-in-class have born lately in the field of migraine, obesity, BPH, etc. Are these meeting patients' expectations? How is patient need/expectation known? What are consumers after? Are there gaps not met in terms of self-care? What are the criteria that matter for consumers and patients in a switching process both by industry and regulators? All these challenging questions will be addressed in this session giving a prominent role to patients and consumers. Switch: What could be on the horizon? Stephen Mann, Pharmaceutical Consultant, Co-Editor, SelfCare Journal, UK Voice of the Patients/Consumers Speaker invited 14:00-15:30 Session 0503 CHANGING REGULATORY ENVIRONMENT: IMPACT ON THE SELF-CARE SECTOR Session Chair: Shirley Norton, Deputy Director, Vigilance and Risk Management Division, MHRA, UK The last year or so has brought a number of changes in the pharmaceutical landscape: a new commissioner, a new DG, new strategic direction of the Agency and of the HMA, early experience with the variation regulations and possibly new legislations in pharmacovigilance and in the context of falsified medicines. The session will reflect on the impact these changes may have on the self-care sector and how it may adapt. Overview of the New Legislative and Regulatory Landscape European Commission speaker invited Will the Self-Care Industry be Better Off? Speaker invited Views of a National Competent Authority Regulator invited 16:00-17:30 Session 0504 IS THE PATIENT/CONSUMER ADEQUATELY INFORMED? Session Chair: Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU We are witnessing a breathtaking evolution of new forms of digital communication. All of this is unfolding so quickly that we do not have time to pause and reflect on what is happening. Providing 'the right information, in the right place, at the right time' is even more crucial in a non-prescription environment where the intervention of a healthcare professional is optional. This session therefore proposes to explore amongst industry, regulators and consumer organisations ways to improve the quality of the conventional forms of communication on non-prescription medicines, to debate ways to disseminate such information more effectively and the potential for individualising such information to the consumer/patient needs. Industry View Helen Darracott, Director of Legal & Regulatory Affairs, PAGB, UK The Regulators’ Perspective Isabelle Moulon, Head of Medical Information, European Medicines Agency, EU Consumers’ Perspective Ilaria Passarani, Health Policy Officer, BEUC -The European Consumers’ Organisation, Belgium The Patient’s Point of View Ian Banks, President, European Men’s Health Forum, UK
THEME 5 25 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Wednesday, 30 March 2011 09:00-10:30 Session 0505 SUPPLY OF QUALITY MEDICINES TO DEVELOPING COUNTRIES Session Chair: Milan Smid, Technical Officer, Prequalification of Medicines Programme, WHO, Switzerland Needs of essential medicines and procurement by international organisations will be presented to explain opportunities of involvement in supplies to developing countries. QA policies of international organisations, mechanisms of WHO prequalification and EU ‘Article 58’ assessment will be discussed. Assurance of Availability of High Quality Medicines in Developing Countries Speaker invited WHO Prequalification Programme for Essential Medicines Lembit Rago, Coordinator, Quality Assurance and Safety, Medicines, Policy, and Standards, WHO, Switzerland EU Contribution to the Availability and Quality of Medicines in Low Income Countries Emer Cooke, International Liaison Officer, European Medicines Agency, EU 11:00-12:30 Session 0506 HOW TO INCREASE ACCESS TO BIOSIMILAR MEDICINES Session Chair: Suzette Kox, Senior Director, Scientific Affairs, EGA, Belgium This session looks at the reasons for the generally slow introduction of biosimilar products into clinical practice and discusses approaches on how this new class of products should be optimally regulated in order to deliver the maximum benefit to society and patients. Views from the European Commission - DG Enterprise and Industry, national authorities and the biosimilar medicines industry will be presented. European Commission DG Enterprise and Industry Views and Activities on How to Increase Access to Biosimilar Medicines Christophe Roeland, European Commission, EU Perspective of a Member State’s Medicines Agency Jytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark How to Increase the Introduction of Biosimilar Medicines into Clinical Practice: A biosimilars manufacturer’s point of view Sandy Eisen, Chief Medical Officer, TEVA Pharmaceuticals Europe, UK 14:00-15:30 Session 0507 HOW TO IMPROVE THE CURRENT REGULATORY FRAMEWORK IN ORDER TO INCREASE ACCESS TO GENERIC MEDICINES Session Chair: Beata Stepniewska, Director of Regulatory Affairs, EGA, Belgium The possibility to provide EU citizens with affordable treatment by generic medicines on the next day following patent expiry should be in the interest of all involved parties: patients, healthcare professionals, health authorities and industry. To achieve this objective, there is a need for an efficient regulatory system allowing access to the market in a timely manner. The objective of the session is to discuss possible ways to remove the hurdles and to create a clear, open market that will benefit patients, spur innovation and generate considerable savings with the view to maintaining a sustainable EU healthcare system. The point of view of a representative of the competent regulatory authority and the generic medicines industry will be presented, followed by a panel discussion with additional panelists from the European Commission and a consumer organisation. Possible Ways to Improve the Current Regulatory Framework for Generic Medicines: Industry View Beata Stepniewska, Director of Regulatory Affairs, EGA, Belgium The Regulator’s Perspective Truus Janse-de Hoog , Chair CMD(h), Staff member MEB, European Cluster, Medicines Evaluation Board, The Netherlands Zaide Frias, Head of Regulatory Affairs, European Medicines Agency, EU Panel Discussion with Ilaria Passarani, Health Policy Officer, BEUC - The European Consumers’ Organisation, Belgium 16:00-17:30 Session 0508 PROS AND CONS OF THE CURRENT DECENTRALISED PROCEDURE FOR GENERIC APPLICATIONS Session Chair: Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria The current European regulatory framework offers different approaches for marketing authorisation applications (e.g. CP, DCP) for generic medicinal products. The complexity of continuously changing regulatory requirements (e.g. guideline for BE-studies, new variation regulation, pharma package) applicable to generic applications will be discussed and the latest updates presented. Pros and Cons of the Current DCP for Generic Applications Maren Von Fritschen, Director Regulatory Affairs, PharmaLex, Germany Session under development 2nd Global Animal Health Conference Global Availability of Veterinary Medicines - Providing a Climate for Science and Innovation 23-24 March 2011 London, UK
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