Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese Speaking African Countries

The Project “Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese Speaking African Countries (BERC-Luso)” aims to establish and develop well-grounded, sound, robust and long lasting ethics and regulatory capacities in 5 Portuguese Speaking African Partner Countries, allowing conditions for the development of biomedical research and specifically clinical trials in these countries, in the adoption of international best practices, thus assuring populations’ protection and countries’ development.
About the Project

BERC-Luso is a project of Biomedical Ethics and Regulatory Capacity Building for Portuguese Speaking African Countries, approved and financed by EDCTP2 (The European & Developing Countries Clinical Trials Partnership), with the support of the European Union (EU) and co-financed by the Calouste Gulbenkian Foundation (FCG). It engages 5 sub-Saharan African countries – Angola, Guinea Bissau, Mozambique, São Tomé e Príncipe and Cape-Verde –, working with their NECs and NRAs, in a partnership with Portuguese institutions experts in the field of ethical and regulatory revision - the Portuguese UNESCO Chair in Bioethics (Institute of Bioethics, Portuguese Catholic University), the National Authority of Medicines and Health Products (INFARMED, I.P.), the National Ethics Committee for Clinical Research (CEIC), and the Portuguese Pharmaceutical Society (Competent Authority for Pharmacists);

News and media

On June 17th, another webinar dedicated to the analysis of cases took place, presented by Professor Maria Alexandra Ribeiro, who presented a case of a prospective, randomized (1:1) open and multicenter clinical trial phase IIIb/IV to assess the efficacy and safety of the drug compared to clinical practice.
More Info

79th FIP World Congress of Pharmacy and Pharmaceutical Sciences

September 22-26, 2019, Abu Dhabi, United Arab Emirates

Audience of BERC-Luso Coordination Team with São Tomé and Príncipe Ambassador

March 2019