Training and innovation networks for sustained capacity development related to ethics, regulatory, pharmacovigilance, and related digital regulatory platforms

Expected Impact:Expected ImpactThrough strategic capacity building, digital transformation, and cooperation in SSA, the actions funded under this topic should contribute to the establishment of a resilient and future-ready ethics, regulatory and PV environment.Applicant consortiumIf requested by the applicant consortia, the EDCTP Association may offer technical support for the preparation of their proposal, in particular because of the lump sum nature of the Grant Agreement. The applicant consortia may also decide to include the EDCTP Association as coordinator. In that case, the applicant consortia should contact the EDCTP Association to obtain the estimated amount of the Association’s contribution as well as any other relevant information. The EDCTP Association will timely provide the necessary information to all potential applicants.Expected Outcome:BackgroundEthics bodies, regulatory agencies, and pharmacovigilance (PV) systems in sub-Saharan Africa (SSA) continue to face significant challenges that hinder effective provision of healthcare services, safety reporting and timely regulatory approval for clinical trials, and marketing authorisation of products. These challenges are largely attributed to limited resources, limited training provision and access to mentor expertise, governance constraints, disparities in digital infrastructure, and limited regional and international regulatory alignment. In response, initiatives such as the African Vaccines Regulatory Forum (AVAREF), the African Medicines Regulatory Harmonization (AMRH) Programme and most recently the African Medicines Agency (AMA) have been launched to address these gaps. International bodies, including the World Health Organization (WHO), along with partnerships in SSA, have contributed to bridge the gap by offering technical support, training, and resources to strengthen ethics, regulatory and PV capacities. Public-private partnerships have further supported ethics and regulatory capacity strengthen