Essential Medicines and Biologicals
Medicines and Health Technologies
Mission:Promote the harmonization of the pharmaceutical requirements of vaccines in order to guarantee its quality, safety and efficacy, creating efficient mechanisms to contribute to vaccine availability to all countries in the region.
1. To harmonize requirements for authorization of vaccine clinical trials, and follow up activities that should take place to monitor this harmonization process.
2. To harmonize technical requirements for the registration (marketing authorization) of vaccines; and monitor its implementation.
3. To promote the exchange of information and the convergence and recognition of the vaccine regulation systems among the ANRs of the Region.
4. To set up tools and organize training activities for technical staff of NR agencies in the Region.
5. To harmonize GMP requirements, specifically for vaccines, and follow up activities should take place in order monitor this harmonization process.
6. To promote the establishment of systems for the vigilance of Adverse Events Following Immunization (AEFI) in the region.
7. To identify other important issues on vaccines regulation that may deserve special attention, and establish an appropriate working plan to address them.
Members of the Working Group on Vaccines
- MERCOSUR: Marina Rossi, Argentina.
- ANDEAN COMMUNITY: Maria Teresa Ibarz, Venezuela.
- SICA: Olga Jacobo Casanueva, Cuba.
- NAFTA: Elwyn Griffiths, Canada.
- FIFARMA: Aldo A. Topasio, Chile.
- ALIFAR: Hector Ostrowski.
- MERCOSUR: Maria Fernanda Reis e Thees, Brazil.
- ANDEAN COMMUNITY: Leonor Suarez Cozarelli, Ecuador.
- SICA: Martha Escobar, Panama.
- CARICOM: Stella Harrigin, Trinidad and Tobago.
- FIFARMA: Tarsila Rey, Mexico.
Secretariat (PAHO / WHO)
- Maria Luz Pombo, Washington, DC.