Projeto RegECs da CEDEAO
Este projeto (101103241 — ECOWAS-RegECs) é apoiado pela Global Health EDCTP3 Joint Undertaking e seus membros
Coordenado pela Coalizão para Inovações em Preparação para Epidemias (CEPI)
Os parceiros implementadores são a Food and Drugs Authority, Gana (FDA), a Organização de Saúde da África Ocidental (WAHO) e o Instituto Paul Ehrlich (PEI).
Fortalecimento prático da supervisão regulamentar e ética dos ensaios clínicos na África Ocidental
Aumento dos níveis de maturidade regulatória nos países alvo
The ECOWAS RegECs project aims to improve the capabilities of Economic Community of West African States (ECOWAS) Regulators and Ethics Committees in vaccines clinical research oversight, particularly in the early stages of vaccine development. It seeks to strengthen the regulators' ability to provide scientific advice and assess clinical trial dossiers based on risk-benefit analysis. By exposing National Regulatory Authorities (NRAs) and Ethics Committees (ECs) to the assessment of Lassa Fever vaccines, the project aims to prepare them for emergency use approval and streamline the regular registration process.
The project will promote collaboration between NRAs, ECs and the African Vaccine Regulatory Forum (AVAREF) network for efficient management of clinical research in West Africa and aims to create a Lassa disease-related regulatory and ethics network.
The second main objective of the project is to enhance the Maturity Level of selected ECOWAS NRAs by focused support through FDA Ghana on regulatory systems and clinical trial oversight (Work Package 3).
The WHO Global Benchmarking Tool (GBT) indicators for regulatory systems and clinical trial functions will be used to map the status of ECOWAS countries and develop a strengthening plan for the region.
The consortium collaborates closely with the following entities:
· AVAREF
· Pertinent ethics and regulatory experts
· ASRP, Senegal
