- Palabras clave > adverse event (AE)
- Palabras clave > efficacy and safety of medicines
- Palabras clave > pharmacovigilance
- Palabras clave > pharmacovigilance - capacity building
- Palabras clave > pharmacovigilance systems
- Palabras clave > post marketing surveillance
- Palabras clave > post-market safety surveillance - drugs and vaccines
- Palabras clave > risk/benefit ratio
- Palabras clave > safety - vaccine
- Palabras clave > surveillance
(2014; 65 pages)
Sponsored by the Bill and Melinda Gates Foundation
Drugs and vaccines are reaching unprecedented numbers of people in low- and middle-income countries (LMICs). These products have tremendous potential to save lives and reduce suffering, but many of the countries in which these products will be used do not have the capacity to effectively monitor their post-market safety. International initiatives have sought to address this gap, but have not attracted significant donor or industry support, or political capital and resources from LMIC governments. With new donor funding scarce in this weak global economy, substantial new resources for addressing post-market safety needs may not be forthcoming. Given limited resources and expanding post-market safety needs, a new strategy is needed. This report is the culmination of the seven-month effort of the Safety Surveillance Working Group (SSWG) to develop that strategy.
The strategy developed through the SSWG process is designed to complement and build upon, not duplicate or replace, existing international pharmacovigilance capacity building initiatives, World Health Organization (WHO) standards and technical assistance programs, and disease- and product-specific initiatives. The human and financial resources available to strengthen post-market safety surveillance in developing countries are limited. Synergies must be encouraged and reinforced.
This strategy developed through the SSWG process has five parts...