EuroMEEting - Genetic Alliance UK

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18 THEME 2 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 11:00-12:30 Session 0202/0302 DECISION-MAKING PROCESS OF BENEFIT/RISK ASSESSMENT – A COLLABORATIVE FRAMEWORK APPROACH (JOINT WITH THEME 3) Session Chair: Iman Barilero, Vice President, Regulatory Development Strategy & Policy, H. Lundbeck A/S, Denmark The session will provide an opportunity to discuss the CHMP work on methodologies for B/R assessment and address the views from industry and patients. The use of a consistent and transparent B/R assessment framework for decision making would facilitate communication of the rationale for decisions, but it should retain sufficient flexibility. An area of potential research is the further development of quantitative tools, which should not lead to a B/R ratio expressed as one single figure. Another area that requires deep reflection is how the B/R assessment will be applied in the so-called ‘staggered’ approval and how this approach will be integrated in the newly proposed B/R management plan. The implications of such an approach on the R&D investment should be assessed. CHMP Progress with the Methodologies and Decision-Making of B/R Assessment during the Product Lifecycle Eric Abadie, Chair, CHMP, Chair Pharmacogenomics Working Party, European Medicines Agency; General Directorate, Afssaps, France Industry Views on the Way Forward to Support Effective Decision Making of Benefit/Risk Assessment in Context of Global Development Programmes Iman Barilero, Vice President, Regulatory Development Strategy & Policy, H. Lundbeck A/S, Denmark Contribution of Patient’s organisation in the Decision-Making of B/R Assessment Patient representative invited 14:00-15:30 Session 0203 STRATEGIES TO OBTAIN COMPETITIVE APPROVALS IN A CHANGING ENVIRONMENT Session Chair: Henrik Kim Nielsen, Corporate Vice President, Novo Nordisk A/S, Denmark Six presenters will give their input on how to navigate in the current regulatory environments in order to achieve competitive approvals. After a brief presentation by the speakers, they will be available in break-out groups for in-depth discussion of their topic. A Good Start is Half the Battle: Exploiting the regulatory potential of known active substances by proactive and intelligent strategic planning Sabine Ingrid Hauk, Managing Director, Pharmalex GmbH, Germany Strategies for Navigating the European Regulatory Landscape Victoria English. Editor, Med Nous, UK Orphan Designation of Nimorazole as a Hypoxic Radio Sensitiser in the Treatment of HNSCC Patients Undergoing Radiotherapy Hanne Damgaard Jensen, CEO, Regunic, Denmark Simultaneous Submission in US, EU and Japan Mrs. Lene Thrane, Regulatory Project Director, Novo Nordisk A/S, Denmark The Timing of CPP Use and the Impact on Regulatory Approvals and Patient Access to Medicines in the Emerging Markets Lawrence E Liberti, Executive Director, CMR International Institute for Regulatory Science, USA Charting a Course through Shifting Global Regulatory Tides – How Sponsors Can Plan Today for the Changes of Tomorrow Geoff Fatzinger, Executive Director Regulatory Affairs Europe & Asia Pacific, INC Research, UK 16:00-17:30 Session 0204 DEVELOPING ADVANCED THERAPY MEDICINAL PRODUCTS – CHALLENGES AND OPPORTUNITIES Session Chair: Catarina Edfjäll, Senior Director, Regulatory Affairs Europe, Celgene International SARL, Switzerland This session will cover the functioning and experience to date of the work of the EMA Committee on Advanced Medicines on scientific advice and marketing authorisations as well as industry experience with developing ATMPs and interaction with the CAT. CAT Procedural Updates and Experiences Patrick Celis, Scientific Administrator, Scientific Committee Support, European Medicines Agency, EU Practical Steps towards a Marketing Authorisation for a Gene-Therapy Product Maureen Graham, Managing Director, Diamond BioPharm Ltd., UK CAT View CAT speaker invited Wednesday, 30 March 2011 09:00-10:30 Session 0205/1405 IMPLEMENTATION OF THE REVISED VARIATIONS REGULATION – ARE THE OBJECTIVES BEING MET? (JOINT WITH THEME 14) Session Chair: Michael J. James, Head of CMC Regulatory Advocacy and Intelligence, Global Regulatory Affairs, GlaxoSmithKline, UK The revised Variations Regulation (EC No. 1234/2008) applied from 1st January 2010 to marketed authorisations granted through a mutual recognition process, decentralised procedure or centralised procedure. The overall objectives of this revision were to provide a simpler, clearer and more flexible legislative framework governing variations. Based on 15 months' experience, industry and regulatory experts will provide a perspective on whether these objectives are being met. Specific considerations will be given to experience on procedural aspects, managing CMC changes, and implications for e-Submissions. The Revised Variations Regulation - Are the new ideas at life? Peter Bachmann, Senior Expert, European Drug and Regulatory Affairs, BfArM, Germany Implementation of the Updated EU Variation Regulation – Simpler, clearer and more flexible? Merete Schmiegelow, Director, Regulatory Intelligence, Novo Nordisk A/S, Denmark
THEME 2 19 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Challenges and Opportunities for E-submissions Remco Munnik, Regulatory Affairs Information Manager, Sandoz, B.V., The Netherlands 11:00-12:30 Session 0206 TOWN HALL MEETING – MEET THE REGULATORS Moderator: Christa Wirthumer-Hoche, Deputy Head, AGES PharmMed, Austria The Town Hall Meeting is an open interactive session where participants can ask key decision makers in the European Regulatory system burning questions. The panel will include representatives from the European Medicines Agency, National Competent Authorities and a patient organisation. The topics/ questions discussed are decided by the attendees and should be related to: • Responsibility of the Agencies in the EU network • Authorisation and Maintenance of Medicinal Products; Benefit/Risk Methodologies • Pharmacovigilance • International Cooperation and Inspection-Related Issues • Electronic Submission • The Role of Patient Organisations Responsibilities of the Agencies in the EU Network Noel Wathion, Head of Public Health Protection, European Medicines Agency, EU Aginus Kalis, Chair HMA-MG, Executive Director, Medicines Evaluation Board (MEB), The Netherlands Authorisation and Maintenance of Medicinal Products; Benefit/Risk Methodologies Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU Eric Abadie, Chair CHMP, Chair Pharmacogenomics Working Party, General Director, Afssaps, France Truus Janse-de Hoog , Chair CMD(h), Staff member MEB, European cluster, Medicines Evaluation Board, The Netherlands Pharmacovigilance June Raine, Director, Chair PhVWP, Director, Division of Vigilance Risk Management of Medicines, MHRA, UK Peter Arlett, Head of Pharmacovigilance and Risk Management, European Medicines Agency, EU International Cooperation and Inspection-Related Issues Emer Cooke, International Liaison Officer, European Medicines Agency, EU Electronic Submission Timothy Buxton, Head of Sector, ICT Development, European Medicines Agency, EU The Role of Patient Organisations Albert Van der Zeijden, Board Member, International Alliance of Patients Organisations, UK 14:00-15:30 Session 0207 MEETING THE INFORMATION NEEDS OF THE PATIENT Session Chair: Trine Moulvad, Manager, Novo Nordisk A/S, Denmark guideline while Agencies and Health Care professionals work on improving the communication on benefit-risk assessments and information to patients to improve treatment adherence. The session will discuss what information patients really need and how involved patients are in making decisions about their medicines. How to Comply with the Readability Guideline Dominique Westphal, European Expert, Paul-Ehrlich-Institut (PEI), Germany Communicating Benefit-Risk Assessments and Information from Agencies and HCPs to Patients Stuart Walker, Founder, CMR International Institute for Regulatory Science, UK Patients: How involved are they in the decision about their medicines? Lawrence Berry, CEO, Datapharm, UK 16:00-17:30 Session 0208 HOW TO MAKE THE PRODUCT AVAILABLE TO THE PATIENT Session Chair: Katie Harrison, Associate Director Regulatory Intelligence and Policy, Baxter Healthcare LTD., UK The key need for many patients is to have access to the product. How can this be achieved e.g. through compassionate use programs or early approval options? Practical Aspects of Managing Compassionate Use Programs – Industry's Perspective Mats Ericson, Regulatory Affairs Director, Amgen Ltd., France New Regulatory Background on Compassionate Use Thomas Sudhop, Head of Clinical Trials and Clinical Inspections Unit, BfArM, Germany What the Patient Needs Patient representative invited Panel with Anthony Humphreys, Head of Regulatory, Procedural and Committee Support, European Medicines Agency, EU 11th Conference and Exhibition on European Electronic Document Management - The New Frontiers 1-3 December 2010 Nice, France How do we secure approvals in a changing environment while meeting the information needs of the patient? The MAH has to comply with the requirements of the EU readability
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