Hellen Opolot

Strengthening pharmacovigilance systems through Africa-Europe collaboration: Insights from a regulatory roundtable discussion

Background Many African countries have established national pharmacovigilance (PV) centers under their medicines regulatory authorities, but multiple barriers still limit system performance. Comprehensive, well-enforced PV regulations are often lacking, and the reporting culture...

Multi country training to strengthen leadership among administrative staff of research ethics committees and national regulatory bodies in the East African Community

Clinical research in the East African Community (EAC) has expanded significantly in response to epidemics, increasing the complexity and workload. Research ethics committee (REC) and National research regulatory (NRA) members involved in leadership and administrative work play a...

Collaborative clinical research ethics and regulatory governance in Sub-Saharan Africa: Gaps, challenges and implications

Although some countries in sub-Saharan Africa have strengthened their systems and reached WHO GBT Maturity Level 3, important gaps remain. Addressing these gaps is critical for strengthening clinical research oversight and preparedness. This open letter highlights that ethics and...