RegTrain – PharmTrain

Short Description

The recurrent Ebola epidemics of recent years, as well as other infectious diseases widespread in Africa such as HIV, tuberculosis or malaria, show that effective and safe medicines for the prevention and treatment of these infectious diseases are not, or not sufficiently, available. Under the umbrella name “RegTrain” the BfArM (PharmTrain) together with the Paul Ehrlich Institute (VaccTrain) supports the development of necessary scientific and regulatory capacities in African project countries. In cooperation with the World Health Organization (WHO) and the multinational New Partnership for Africa’s Development agency (AUDA-NEPAD), the following objectives are being pursued:

1. Analysis and evaluation of the current situation in the project countries and preparation of individual development plans for building regulatory structures and scientific capacities.
2. Establishing sustainable training structures according to the Train-the-Trainer principle. Particularly suitable colleagues from the African partner authorities are trained at the BfArM with follow-up support after returning to their home authority, so that they are able to pass on their knowledge and skills to their colleagues in Africa. In addition to North-South cooperation, this also promotes South-South cooperation.
3. The overall objective is to contribute to the establishment of harmonised regulatory structures as well as scientific and regulatory capacities in order to promote cooperation between the authorities of different countries, to strengthen the regulatory system across countries and to improve drug safety.

Video: The PharmTrain project – Its first year

From 2023, the RegTrain-PharmTrain project will continue as a follow-up project under the name PharmTrain2.

In Cooperation with

• Food and Drug Administration (FDA), Ghana
• Liberia Medicines and Health Products Regulatory Authority (LMHRA), Liberia
• Pharmacy Board Sierra Leone (PBSL), Sierra Leone
• Medicines Control Agency (MCA), The Gambia
• Medicines Control Authority of Zimbabwe (MCAZ), Zimbabwe
• Paul-Ehrlich-Institut (PEI), Germany
• World Health Organization (WHO), Switzerland
• New Partnership for Africa’s Development Agency (AUDA-NEPAD), South Africa

Publications and Conference Presentations

• Semete-Makokotlela, B., Mahlangu, G.N., Mukanga, D., Darko, D.M., Stonier, P., Gwaza, L., Nkambule, P., Matsoso, P., Lehnert, R., Rosenkranz, B., and Pillai, G.C. (2022). Needs-driven talent and competency development for the next generation of regulatory scientists in Africa. Br J Clin Pharmacol 88, 579-586. 
• Mbichila, T., Kumwenda, G., Yola, N., Karim, Q. A., Tchelidze, T., Lau, J., Buchholz, S., Lehnert, R., et al. (2021). Commentary title: COVID-19 research, Africa, and global health. Journal of virus eradication, 7(1), 100030. doi:10.1016/j.jve.2021.100030
• “Widening the scope of regulatory capacity building based on the VaccTrain I Pilot” Project Projektpräsentation auf der 4th Biennial Scientific Conference on Medical Products Regulation in Africa (SCOMRA), Regine Lehnert, 30.09 – 01.10.2019, Victoria Falls, Simbabwe

Last update: December 2022