Project profile — CHVI - Sustainable Regulatory Development to Accelerate Access to HIV Vaccines

• Africa, regional (100.00%)

• Population Policies/Programmes And Reproductive Health: STD control including HIV/AIDS (13040) (100.00%)

• Gender equality (not targeted)
• Environmental sustainability (cross-cutting) (not targeted)
• Participatory development and good governance (not targeted)
• Trade development (not targeted)
• Biodiversity (not targeted)
• Climate change mitigation (not targeted)
• Climate Change Adaptation (not targeted)
• Desertification (not targeted)
• Urban issues (not targeted)
• Children's issues (not targeted)
• Youth Issues (not targeted)
• Indigenous Issues (not targeted)
• Disability (not targeted)
• ICT as a tool for development (not targeted)

The goal of this program under the Policy and Regulatory Issues component of Canadian HIV Vaccine Initiative (CHVI) is to support activities to improve regulatory capacity in low- and middle-income countries, especially those where clinical trials are planned or ongoing. The program supports the integration of ethical review, regulation, and registration of clinical trials in Africa. It promotes and strengthens the collaboration between ethical committees and regulatory authorities in the targeted African countries. Finally, it develops training material, including e-learning tools for national regulatory authorities and ethics committees.

N/A

Results achieved as of June 2013 include: The African Vaccine Regulatory Forum (AVAREF) was formalized and courses on the inspection of good clinical practices as well as on the evaluation of clinical data were provided in the 19 AVAREF member countries. A course on legislation was developed to support national review authorities in the development of the legal framework for clinical trials. This course was delivered to 17 participants representing ten low and middle-income countries. The project also strengthened monitoring practices through the development of indicators that support research ethical committees and research institutions in low and middle-income countries to meet international ethics standards when conducting research with human participants.

• Proactive disclosure