VaccTrain Next
Capacity development in the area of regulatory oversight in clinical research of vaccines and biologicals for African countries
Context
Currently, only 3% of all global clinical trials are conducted in Africa, even though Africa accounts for 17% of the world’s population and has the greatest genetic diversity. This can significantly delay local access to new, urgently needed safe and efficacious vaccines and medicines. The follow-up project VaccTrain Next aims to strengthen the scientific and regulatory competencies of national regulatory authorities (NRAs) in seven African project countries. The focus is on the evaluation of innovative technologies for new vaccines, the improvement of the quality of clinical trials. It also includes collaborating with ethics committees to ensure compliance with internationally recognised scientific standards. To achieve this, the project supports the development of harmonised regulatory standards for conducting clinical trials and their implementation in Africa. Furthermore, VaccTrain Next conducts targeted regulatory and scientific training, also in cooperation with the African Vaccine Regulatory Forum and other international partners. In addition, the project supports specifically regional centers of regulatory excellence for clinical trials and pharmacovigilance. Their task is to train further regulators in their respective economic regions in Africa. This facilitates knowledge transfer in Africa and promotes South-South cooperation.
Objective
Improved response capacity of African partner countries to public health emergencies by strengthening the regulatory and scientific capacity of national regulatory authorities to monitor clinical trials for vaccines and biologicals
In Cooperation with
- Food and Drugs Authority Ghana, Accra, Ghana
- Medicines Control Authority of Zimbabwe, Harare, Zimbabwe
- National Drug Authority, Kampala, Uganda
- Pharmacy and Poisons Board, Nairobi, Kenya
- Botswana Medicines Regulatory Authority, Gaborone, Botswana
- Rwanda Food and Drugs Authority, Kigali, Rwanda
- Egyptian Drug Authority, Cairo, Egypt
- African Union Development Agency-New Partnership for Africa’s Development (AUDA NEPAD), technical committees African Vaccine Regulatory Forum (AVAREF) and African Union Smart Safety Surveillance (AU-3S), Johannesburg, South Africa
- WHO AFRO, Brazzaville, Republic of the Congo
- Coalition of Epidemic Preparedness Innovations (CEPI), Oslo, Norway
Thematic priorities
Facts
Activities
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Networking and cooperation
VaccTrain Next supports regional institutions in Africa, such as the regional centres of regulatory excellence (RCORE) and the regulatory working groups of WHO AFRO/AMRH/AMA. Moreover, it promotes Africa-wide harmonisation of regulatory processes and the scientific assessment of clinical trial applications through cooperation with the African Vaccine Regulatory Forum (AVAREF) and CEPI.
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Capacity building
The project supports the development of regulatory capacity in the areas of regulatory approval and oversight of clinical trials and improved responsiveness to health crises. It assists in the development of regulatory procedures, guidelines, and tools to promote the institutional development of NRAs. VaccTrain Next also supports RCORE training activities.
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Training and competence development
The project provides training to employees of national drug regulatory authorities. They are particularly trained and educated in the monitoring and approval of clinical trials, the regulatory oversight in the conduct of clinical trials and in the evaluation of clinical study data.
