- Palabras clave > African Medicines Regulatory Harmonization (AMRH)
- Palabras clave > clinical trials registration
- Palabras clave > harmonization of medicines regulation
- Palabras clave > marketing authorization
- Palabras clave > medicines registration
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > pharmacovigilance - capacity building
- Palabras clave > registration of medicinal products
- Palabras clave > regulatory harmonization
- Palabras clave > regulatory institutional capacity
- Palabras clave > enregistrement des médicaments
(2015; 38 pages)
African Union Commission (AUC), NEPAD Agency and the World Health Organization (WHO) are organizing the 2nd Biennial Scientific Conference on Medicines Regulation in Africa (SCoMRA) and the 4th African Medicines Regulators Conference (AMRC).
The theme of the 2nd conference is “Regulatory Systems Strengthning for advancing Research, Innovation and local pharmaceutical production in Africa”. The conference will seek to position medical products regulation in Africa as a strategic framework for effectively contributing to Post 2015 development agenda and the African Union Agenda 2063 by facilitating access to the needed medical products, vaccines and technologies. The overall goal of the Second Biennial Scientific Conference on Medicines Regulation in Africa is to enable stakeholders to discuss how to strategically position medical products regulatory systems as a key aspect in facilitating research and development and local production of the needed medical products for diseases disproportionately affecting the people of Africa.
It will bring together representatives from regional economic communities (RECs), regulators from African Union Member States, foreign NMRAs, members of national ethics committees/ Institutional Review Boards (IRB), industry representatives, regulatory affairs professionals, scientists, academia, health financing specialists, and development partners in health and pharmaceutical Sectors in Africa.
While the 4th AMRC will be preceded by the 2nd Biennial Scientific Conference on Medicines Regulation in Africa, the conference will review the status of the regulation of medical products in the Region, identify challenges, and propose solutions for improvement within current global and regional contexts. In addition, the conference will agree on modalities for accelerating information sharing on medicines regulation and harmonization in Africa and regulation of medical devices, diagnostics and blood products. The general objective of the 4th AMRC is to support countries to accelerate the pace of establishing functional medicines regulatory agencies at national, regional and continental levels and strengthening the capacities of existing NMRAs in the Region.
The AMRC will bring together regulators from the African Union member states; representatives of pharmaceutical industry associations, regional economic communities and partners.