Strengthening Research Partnerships for Better Health and Sustainable Development
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1 11-14 June 2012 Strengthening Research Partnerships for Better Health and Sustainable Development AIFA-UNICRI-OPBG-NIMR Training Course on GCP in Developing Settings: the promotion of international harmonisation for respect of ethical principles, human rights and justice
2 Mission and objectives of EDCTP To reduce the burden of poverty related diseases (HIV/AIDS, malaria and tuberculosis) and generally improve the health of people living in developing countries by accelerating research and development of new or improved interventions against these diseases through the coordination of the European member state national programmes working in partnership with sub-saharan countries
3 Strengthening of clinical trials capacity and the enabling environment
4 EDCTP Regional Networks of Excellence for clinical trials Western Africa: WANETAM Website: Project Coordinator: Prof. Soleymane Mboup Burkina Faso The Gambia Ghana Guinea-Bissau Mali Central Nigeria Africa: CANTAM Website: Senegal United States Project Coordinator: Prof. Francine Ntoumi Cameroon Congo, Republic of the Gabon France Eastern Germany Africa: EACCR Website: Project Coordinator: Dr Pontiano Kaleebu Kenya Sudan Ethiopia Tanzania Uganda Germany Southern Sweden Africa: TESA United Kingdom Website: United States Project Coordinator: Dr Alexander Pym Botswana Malawi Mozambique South Africa Zambia
5 Good clinical laboratory practice Source: ASLM
6 Regulatory framework Ineffective regulatory systems pose public health risks May allow marketing of unsafe and inefficacious products Weakness and lack of harmonisation in regulatory framework create barriers to free movement of products and access between countries May deprive patients of the needed products
7 African Vaccines Regulatory Forum (AVAREF) Training Joint review of clinical trial applications and GCP inspections Harmonisation in collaboration with the African Medicines Regulatory Harmonisation (AMRH) initiative Cordination of activities with National Ethics Committee and the Pan African Clinical Trials Registry (PACTR)
8 Ethics committes Establishment and day-to-day running of ethics committees/institutional review boards Office equipment Standard Operating Procedures Administration Communication Mapping of ethics review and regulatory capacity (MARC) Sustainable, interactive and self-updating web-based African map of research ethics review and drug regulation capacity Tranining/workshops e-learning: AMANET, TRREE
9 Mapping of Research Ethics Review and Regulatory Capacity in Africa (MARC) Further information Gorvenance and policies Research ethics review Research regulations Regional research priorities Key institutions and networks National doscuments Research financing and partnerships Information resources Country reports
10 Clinical trials registration Why register clinical trials Transparency Avoid duplication/wastage Avoid selective reporting: availability of information on failed projects or negative results The Pan-African Clinical Trials Registry (PACTR) Regional register of clinical trials conducted in Africa Searchable electronic database of on-going and planned clinical trials Customised to ease registration bearing in mind difficulties of internet connectivity in Africa provision for registration by post, s or facsimile
11 The EDCTP partnership EDCTP-EEIG member states Austria Belgium Denmark France Germany Greece Ireland Italy Luxembourg Netherlands Norway Portugal Sub-Saharan Spain African countries Sweden Benin Switzerland Botswana United Kingdom Burkina Faso Cameroon Congo Cote d Ivoire Democratic Republic of Congo Ethiopia Gabon Ghana Guinea Guinea-Bissau Guinea-Conakry Kenya Liberia Madagascar Malawi
12 Thank you
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