Project: Upgrading national ethics review systems and regulatory bodies in Senegal

Acronym	SEN-ETHICS (Reference Number: CSA2017ERC-1925)
Duration	01/11/2018 - 30/04/2021
Project Topic	Ethical and regulatory evaluations systems are central to health in a developing country. They are key for ensuring high quality clinical trials and safe interventions using drugs, vaccines or other medical products and devices for patients who need them most. In Africa, human and institutional resources should therefore be constantly assessed and upgraded to fully comply with the international standards. The World Health Organization) recognizes the importance of drugs in the management of health and wisely includes regulatory system functions as one of the six core building blocks of health systems: access to medical products, vaccines, and technologies of assured quality, safety, and efficacy. The EDCTP call for proposals entitled 'Ethics & Regulatory Capacities'; call identifier: CSA2017ERC, offers to Senegal a unique opportunity to upgrade government’s drug regulatory and ethical authorities, namely the National Council for Ethics and Health Research (CNERS) and the Department of Pharmacy and Medicine (DPM), to better professionalize the current ethical and regulatory evaluation systems. SEN-ETHICS is aiming to strengthen CNERS and DPM for better governance of clinical research and other regulatory functions. This will be done by starting with a situational analysis to identify gaps, needs and opportunities. Current tools and procedures will be reviewed, updated and harmonized for better inter institutional and inter disciplinary collaboration. SEN-ETHICS will assist Senegal for the establishment of institutional review boards and for the training of 160 civil servants, health executives on ethical and regulatory evaluation systems. Collaboration with the regional regulatory agencies such as the African Vaccine Regulatory Forum (AVAREF) is already secured. Other partnerships within the Developing Countries Vaccine Regulators Network (DCVRN) and African Medicines Regulatory Harmonization Program (AMRH) and its current eleven Regional Centers for Regulatory Excellence (RCOREs) will be sought. SEN-ETHICS operational activities will be spread across four work packages that arenamely (i) project management, (ii) capacity building, (iii) ethics and regulation and (iv) networking/ communication/ capacitation.
Network	EDCTP2
Call	Ethics and regulatory capacities 2017

Project partner

Number	Name	Role	Country
1	Ministry of Health and Social Action, Senegal	Coordinator	Senegal
2	Réseau Africain de Recherche sur le SIDA	Partner	Senegal
3	Université Cheikh Anta Diop de Dakar	Partner	Senegal