VaccTrain: Second Phase of Project begins with Benchmarking & Training Sessions
In spring and summer of 2023, the VaccTrain team conducted on-site assessments of the needs of the three West African medicines regulatory authorities in clinical trial oversight and drug safety. This benchmarking led to the tailor-made project roadmap.
Needs-based plan for building structures and skills
VaccTrain continues to support its partners in building regulatory capacity during the second phase of the GHPP. The VaccTrain team visited three of its five partner countries, The Gambia, Liberia, and Sierra Leone, between February and July 2023. During this, the project teams assessed the regulatory capacity of the authorities using the WHO’s internationally standardized tool, the “Global Benchmarking Tool (GBT)”. The on-site assessment provided all partners with a transparent overview of the progress made since start of our collaboration within the VaccTrain project in 2017, the implementation of the regulatory structures developed so far, and the remaining challenges and gaps. “Thanks to the openness of our partners, the country visits were very informative and essential for meaningful benchmarkings. These insights help us to better understand their actual day-to-day challenges and how we can specifically support them to overcome it”, emphasizes Dr. Heidi Meyer, Lead of the VaccTrain project. Based on the results of these benchmarkings and the individual priorities set by our partner authorities tailored country-specific work plans were established to further strengthen the three authorities in their capacity for regulating clinical trials and monitoring drug safety (pharmacovigilance).
Joint training promotes a harmonised approach
The country visits to Sierra Leone and The Gambia were also used by the VaccTrain team to strengthen partners’ skills in pharmacovigilance. The training workshop in Sierra Leone, for example, was attended on-site by eleven regulators from The Gambia, Liberia and Sierra Leone. In addition, ten employees from the MCAZ in Zimbabwe were virtually participating. The training focused on practical exercises in pharmacovigilance, such as routine benefit-risk assessments, methods and algorithms for causality assessment and risk minimisation measures. The joint training with four partner countries promoted exchange, builds trust and is intended to lay the foundation for a harmonised, standardised approach.
Mission of the project: Strong regulation for safe and effective vaccines
The VaccTrain project focuses on capacity building in the regulatory areas of “clinical trials oversight” and medicines safety monitoring (“pharmacovigilance”). These are crucial tasks of a medicines regulatory authority to ensure that new vaccine candidates or medicines are tested rapidly and according to the required ethical and scientific standards in clinical trials while patient safety is maintained. Even after vaccines and drugs have been approved, monitoring their safety, known as pharmacovigilance, is an ongoing task of many regulatory agencies. This involves registering suspected cases of adverse events, evaluating them and, if necessary, initiating appropriate steps to minimise and prevent risks. For authorities to be effective in their regulatory role, they need clearly defined responsibilities, guidelines, standard procedures and trained staff. This is where the VaccTrain project provides support. Since 2017, it has been working with its three partner authorities to develop appropriate structures in accordance with international standards, strengthen competencies in the authorities through training, and support harmonised structures across Africa.
Dates of Benchmarkings und Trainings:
20.– 24. February 2023, Monrovia, Liberia
28.– 31. March 2023, Freetown, Sierra Leone
03.– 07. July 2023, Banjul, The Gambia
