Strengthening clinical trial capacities in Lusophone Africa: training NRAs reviewers

From 9 to 13 June 2025, WHO-AFRO, through AVAREF, in collaboration with various partners, including the EDCTP Association, ANVISA, INFARMED, and ANARME, conducted its inaugural Portuguese-language training on clinical trials in Maputo, Mozambique. This significant event saw the participation of nineteen evaluators from six different countries, all of whom enhanced their skills in harmonised clinical trial assessments.

The EDCTP Association was represented by Dr Baltazar Cá, General Assembly Representative for Guinea-Bissau, who facilitated two engaging training sessions focusing on (1) an overview of quality management systems and (2) safety reporting in clinical trials.

This comprehensive training series aimed to equip scientific reviewers within the National Regulatory Authorities (NRAs) with the necessary skills to effectively review clinical trial dossiers. The courses, offered through the Research Ethics Committees (RECs), are designed to optimise the selection of appropriate reviewers from the relevant agencies, promote familiarity with AVAREF tools, guidelines, and processes for clinical trial reviews, and encourage the adoption of these essential tools.

The regional training initiative is expected to play a vital role in the institutional development plan, empowering countries to operationalise their regulatory functions effectively.

For more information and to access the AVAREF Clinical Trials Assessment guidance tools, please visit the WHO African Region website.