Rosemarie D. L. C. Bernabe

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...

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...