European Information Network - Ethics in Medicine and Biotechnology
A project of the European Commission,Quality of Life and Management of Living Resources Programme
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European Information Network - Ethics in Medicine and BiotechnologyA project of the European Commission,Quality of Life and Management of Living Resources Programme |
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| Date: | 11.12.2003, 09:15h to 12.12.2003, 13:00h |
| Location: | Hilton London Metropole Hotel London United Kingdom |
| Keywords: | Ethics committees - Health care system/Health policy - Pharmaceutics/drugs |
| Details: | WORKSHOP DESCRIPTION: A first EMEA Workshop on ethical considerations in clinical trials was held at the EMEA in November 2001. For the first time an open dialogue took place between Ethics Committees and the EMEA on ethical considerations relating to the design and conduct of clinical trials for medicinal products for human use. Participants requested a follow-up meeting as further opportunity for communication between Ethics Committees and regulatory bodies. Other initiatives were taken at European level: a European Conference on Clinical Trials & Ethics organised by the EFGCP at the European Parliament in September 1997, and the EFGCP Workshop on Education Programmes for Research Ethics Committee Members in Europe on 3 December 2002. This workshop examines the current legal and regulatory requirements for ethical review in Europe, based largely on Directive 2001/20/EC and the supporting 'Detailed guidance on the application format and documentation to be submitted in an application for an ethics committee opinion on a clinical trial on a medicinal product for human use'. The workshop considers these legal and technical requirements in relation to EU and Candidate Member State systems and practices for ethical review. It also explores the relation between EU and national requirements in the context of international guidance in the area of ethical review. The current regulatory situation at the national and European levels provides a focal point for discussion, with the aim of integrating ethical review more closely into the development of health research policy. The systems of ethical review in the various European countries are examined against the background of developments at the European and international levels. At the same time, specific challenges for ethical review are examined in the context of growing expectations and societal reliance on the capacity of ethical review to protect research subjects and ensure the responsible development of health research, especially in the framework of research and clinical development of new technologies and pharmacogenetics. WORKSHOP TOPICS: The workshop focuses on the legal and regulatory expectations for ethical review in Europe. Within this focus, the following topics are discussed: * Directive 2001/20/EC & The Supporting Implementing Texts (esp., Applications to ECs) * Procedures for Regulatory Review of Health (Medicines) Research in Europe - both at the EMEA level and the national levels * National Guidance on Ethical Review in Europe * International Guidance on Ethical Review (WMA) * Challenges to Ethical Review (financing ethical review, follow-up on approved applications, SAE review) * European and International Issues in Ethical Review (research methodology [e.g., placebo]), standard of care, access to medicines during and post research participation, reviewing research in developing countries) * Situating European Ethical Review Practices in a Wider Global Context of Ethical Review and Regulatory Expectations * Examining Needs for Education for Members of Ethics Committees in Europe WORKSHOP FORMAT: The workshop is structured around plenary sessions that will address general topics affecting ethical review and regulatory expectations throughout Europe. There are breakout sessions for working groups to address specific challenges and different approaches in Ethical Review for Members States, trying to achieve a shared European approach. The impact of the EU enlargement on Ethics Committees in candidate countries will also be addressed. WORKSHOP PARTICIPANTS: The workshop invites members of European ethics committees and regulatory authorities to participate. It also invites representatives of European health and research authorities, as well as national ethics committees' organisations, educators, and oversight authorities. Members of research sponsoring organisations (governmental and non-governmental) as well as representatives of international organisations providing guidance and support for ethical review are invited. Leading representatives of ethics committees in other regions of the world are also invited to participate. WORKSHOP LANGUAGE: The language of the workshop is English. |
| Organizer: | The European Agency for the Evaluation of Medicinal Products; The European Forum for Good Clinical Practise |
| Contact: | Stéphanie Bouchard Address: EFGCP Conferences Secretariat, Downtown Europe, Avenue de la Chasse 198, B-1040 Brussels, Belgium Tel: +32 - 2 - 7 32 35 20 Fax: +32 - 2 - 7 36 89 30 Email: conferences@efgcp.org |
| Webpage: | http://www.efgcp.org/index.asp?div=events_up&id=events_up |
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