- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Mots-clés > African Medicines Regulatory Harmonization (AMRH)
- Mots-clés > harmonization of pharmacovigilance
- Mots-clés > medicine safety
- Mots-clés > national regulatory systems - assessment
- Mots-clés > national reporting systems - adverse reactions to medicines
- Mots-clés > pharmacovigilance
- Mots-clés > pharmacovigilance reporting system
- Mots-clés > post marketing surveillance
- Mots-clés > regulatory harmonization
- Mots-clés > safety
- Mots-clés > seguridad de los medicamentos
(2012; 52 pages)
Ouma, C., and E. Abwao. 2012. Africa Pharmacovigilance Meeting 2012: Technical Report. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services Program. Arlington, VA: Management Sciences for Health.
The US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program, a follow on to the SPS program, implemented by Management Sciences for Health (MSH), is implementing an interagency agreement between the USAID and US Food and Drug Administration (FDA)that is aimed at fostering collaboration between the two agencies to strengthening regulatory systems to ensure the quality and safety of health products in the supply chain of developing countries...
Through this interagency agreement, an assessment in 46 sub-Saharan African countries was conducted to assess medicines safety and quality systems performance. In 2011, the assessment report Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance was published. The publication was launched at the 2012 Africa Pharmacovigilance Meeting held at the Intercontinental Hotel in Nairobi, Kenya, held April 18–20, 2012.
The meeting was attended by 110 participants from 32 countries and included a one-day assessment dissemination conference and two-day workshop to identify priority package of tools and guidance documents related to pharmacovigilance (PV) and regulatory systems strengthening. The meeting brought together partners from the global regulatory and pharmacovigilance community, including the World Health Organization (WHO), the Bill & Melinda Gates Foundation (BMGF), the European Medicines Agency (EMA), the US Centers for Disease Control and Prevention, the FDA, the USAID, as well as national regulatory authorities and national public health programs.
The report below contains proceedings from the three-day meeting.