The Ebola epidemic in West Africa has shown that vaccines and therapeutics are not readily available to control an epidemic quickly. In many cases, health systems are overwhelmed under those conditions. Essential clinical trials can only take place with restrictions and delays, if at all.
The RegTrain-VaccTrain project aims to support the development of the scientific and regulatory capacity necessary to address these challenges in African partner countries. The purpose is to establish a harmonized regulatory framework on the continent and to encourage cooperation between different African national regulatory authorities. These activities are conducted in close collaboration with the World Health Organization (WHO) and various African and international organizations.
An important element in this project is the assessment and analysis of the current regulatory system in partner countries, especially for marketing authorizations, pharmacovigilance, and clinical trials. These results are then used to create a development program together with the selected countries.
Objectives of the Project
- to strengthen national regulatory authorities
- to promote universal access to medicines, especially vaccines, to improve global health standards permanently
- to contribute to the achievement of the WHO Millennium Goals, especially to reduce maternal and infant mortality
In Cooperation with
- Food and Drugs Authority Ghana (FDA), Ghana
- Liberia Medicines & Health Products Regulatory Authority (LMHRA), Liberia
- Pharmacy Board of Sierra Leone (PBSL), Sierra Leone
- Medicines Control Agency (MCA), The Gambia
- Medicines Control Authority of Zimbabwe (MCAZ), Zimbabwe
- African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD), South Africa
- African Vaccine Regulatory Forum (AVAREF
- Federal Institute for Drugs and Medical Devices (BfArM), Germany
- World Health Organization (WHO), Switzerland
Publications and Presentations
- Leveraging WHO’s Global Benchmarking Tool to strengthen capacity in clinical trials oversight for public health emergencies: the GHPP VaccTrain model.(Owusu Sekyere S, Škrnjug-Yudov I. et al.); in: Global Health. 2022 Jun 20;18(1):63. doi: 10.1186/s12992-022-00854-0.
- The Pivotal Role of Quality Technical Structures for Clinical Trials Oversight in the Achievement of Long-Term Capacity Strengthening Outcomes(Owusu Sekyere Solomon, Škrnjug-Yudov Ivana, et al.); in: Frontiers in Medicine, 9/ 2022
- DGTI 2021: E-learning approach for capacity building in the area of regulatory systems strengthening in Africa. (Pinz A, et al.) ePoster (PS-4-6), DGTI 2021.
- Clinical Trials regulation during emergencies: Liberia, an emerging regulatory system experiences through the EVD & COVID- 19 outbreaks. (Kercula J D, Owusu Sekyere S, Smith K C) 5th Scientific Conference on Medical Products Regulation in Africa (SCoMRA V) and the 7th African Medicines Regulators Conference (AMRC VII), 2021.
- SCoMRA-Präsentation 2021: Leveraging WHO’s GBT to strengthen capacity in Clinical Trials Oversight for public health emergencies: The GHPP VaccTrain model”, Dr. Solomon Owusu Sekyere,
5. Scientific Conference on Medical Products Regulation in Africa (SCoMRA V)
- SCoMRA-Präsentation 2019: “Clinical Trials Oversight in Liberia: Where are we?” (Pharm Juwe D. Kercula (LMHRA), Dr. Ivana Škrnjug (PEI)), 4th Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA), Victoria Falls, Zimbabwe, 30th September- 01st October, 2019
- Mutual recognition in the European system: A blueprint for increasing access to medicines? (I. Škrnjug et al.), in: Regulatory Toxicology and Pharmacology, Volume 106, August 2019, Pages 270-277.
Last update: December 2022