000341894 001__ 341894
000341894 005__ 20230827173330.0
000341894 0247_ $$2CORDIS$$aG:(EU-Grant)101103195$$d101103195
000341894 0247_ $$2CORDIS$$aG:(EU-Call)HORIZON-JU-GH-EDCTP3-2022-01$$dHORIZON-JU-GH-EDCTP3-2022-01
000341894 0247_ $$2originalID$$acorda_____he::101103195
000341894 035__ $$aG:(EU-Grant)101103195
000341894 150__ $$aStrengthening Regulatory Capacities for Clinical Trials Oversight in Southern Africa: South-South and South-North Collaboration Initiative for Regulatory Bodies.$$y2023-07-01 - 2026-06-30
000341894 372__ $$aHORIZON-JU-GH-EDCTP3-2022-01$$s2023-07-01$$t2026-06-30
000341894 450__ $$aSEARCH II$$wd$$y2023-07-01 - 2026-06-30
000341894 5101_ $$0I:(DE-588b)5098525-5$$2CORDIS$$aEuropean Union
000341894 680__ $$aThe Southern Africa Regulatory for Clinical Research (SEARCH) is a consortium established in 2020 under the second program of the EDCTP, designed to develop and promote a framework for collaboration, harmonization process and support regulatory capacity and develop technical expertise in Southern African countries to support the conduct of clinical trials (CT). It is composed of four institutions from Southern Africa and one European. In this proposal, SEARCH II, eight institutions come together to strengthen and increase the capacities for the clinical trials review process in Southern Africa built from the SEARCH I project, including the issuance of relevant permits, CT oversight and clinical research pharmacovigilance and post-trial market authorisation by NRAs. However, insufficient access to quality, safe, efficacious and affordable medical products in Southern Africa has imposed significant challenges on public health for decades. This, in part, is attributed to weakness or absence of technical expertise, lack of policies, guidelines and regulatory systems, a lack of competent regulatory professionals in the National Medicines Regulatory Authority (NMRAs) and ineffective regional collaborations among the NRAs and NECs. In response to these regulatory challenges, the SEARCH I project initiated a process of regional harmonisation efforts and conducted SWOT analysis among the southern African members, and developed a comprehensive common plan for continuous improvement and overcoming gaps at the beneficiary country level and effective harmonization of regulatory and ethical review processes. The SEARCH II project aims to support the national regulatory capacity system, develop technical expertise and continue promoting the South-South and North-South collaboration built from the SEARCH I project, while also enhancing and advocating the establishment and structuring of NRAs and NECs in Botswana, Eswatini, Lesotho, Mozambique, Namibia and Zambia.
000341894 909CO $$ooai:juser.fz-juelich.de:1011253$$pauthority:GRANT$$pauthority
000341894 909CO $$ooai:juser.fz-juelich.de:1011253
000341894 980__ $$aG
000341894 980__ $$aCORDIS
000341894 980__ $$aAUTHORITY