Initially created in 2006 by the World Health Organization, the African Vaccine Regulatory Forum (AVAREF) was created as an informal capacity building platform dedicated to improving the regulatory and ethical oversight of interventional clinical trials in Africa. In 2016, a revised governance structure was agreed upon and the remit of AVAREF was expanded to include all interventional clinical trials in Africa.
AVAREF seeks to enhance the efficiency and quality of regulatory and ethical reviews and inspections, develop and disseminate harmonized guidelines and approaches, protect participant and patient safety, and improve the timeliness of regulatory decisions for all trials. As a pan-African network, AVAREF is an important contributor to the African Medicines Regulatory Harmonization (AMRH) initiative and the future African Medicines Agency (AMA). Dr. Bierer was invited to describe the work of the MRCT Center and to participate in discussions of capacity building and regulatory systems strengthening.