Project: Competence-based Fellowship for African Medicines Reviewers and Regulatory Science Professionals

Acronym Reg. Science-Fellows (Reference Number: CSA2017ERC-1910)
Duration 01/11/2018 - 31/10/2021
Project Topic Limited availability of medicines reviewers and regulatory science staff is a challenge for the medicines control authority of Zimbabwe (MCAZ) and other sub-Saharan African national medicine regulatory authorities (NMRAs). The overall goal of the project proposal is to provide sufficient number of competent and well- experienced medicine reviewers and regulatory science professionals with specialised training necessary to review (a) new medicines that require first time review by African NMRAs, (b) complex products such as biotechnology or biosimilars as well as (c) bioequivalence data for simple and complex generic medicines. A limitation of the few available postgraduate training courses in regulatory science / affairs is their lack of experiential training. An integrated model of regulatory science and experiential learning opportunities, which includes a rotation-based training program at the NMRA or industry is therefore critical. In this regard, MCAZ will not only offer a structured and formalised two three-week competence-based short courses, and a 2-year fellowship in regulatory sciences as well as annual proficiency testing for its own staff, but also to other African NMRAs through its designation as a Regional Centre of Regulatory Excellence (RCORE). The first objective focuses on training at least 100 regulatory staff through 4 competence-based courses offered annually (total of 12 for the grant period). The second objective is to implement a fellowship program in regulatory science targeted at 10 fellows over the 3 years. The fellowship will involve completion of the competence short courses through block release training of fellows at MCAZ/UZ, completing summer and winter courses in Utrecht-WHO Collaborating Centre, some practical work assignments and case studies, specific hours of practice (medicine reviews) over the fellowship period and a capstone project. The total budget for this program is €315,444.36 for 3 years, of which €270,329.61 is requested from EDCTP (direct costs). MCAZ will contribute €33,817.46. The short courses are run on a cost recovery basis. Eight fellows will be supported through full scholarship, while the remaining 2 will be on self-sponsorship. Developing sufficient numbers of competent medicine reviewers and regulatory science staff will strengthen the functionality, recognition and performance of NMRAs in sub-Saharan African countries. This will ensure the application of appropriate risk benefit approaches and regulatory pathways related to clinical trials and registration of new medicinal products to strike a balance between the public health interest, the interests of the pharmaceutical industry, and ethical values.
Network EDCTP2
Call Ethics and regulatory capacities 2017

Project partner

Number Name Role Country
1 Medicines Control Authority of Zimbabwe Coordinator Zimbawe
2 University of Zimbabwe Partner Zimbawe