Train-the-Trainer Programme for African Regulatory Authorities at Paul-Ehrlich-Institut
The VaccTrain 2.0 project conducted two 14-day train-the-trainer courses in the spring and autumn of 2024. Authority employees from The Gambia, Liberia, Sierra Leone, and Zimbabwe attended the training at the Paul-Ehrlich-Institut. The course focused on how to facilitate training in evaluating applications for clinical trials of biomedical therapeutics and vaccines as well as monitoring of drug safety. The aim was to prepare for new vaccines and increasingly locally produced medicines.
Advanced course for two trainers from Zimbabwe
The Medicines Control Authority of Zimbabwe (MCAZ) is one of the well-established medicines regulatory authorities in Africa. The MCAZ has recently achieved the World Health Organization (WHO) Maturity Level 3. As a certified Regional Center of Regulatory Excellence (RCORE) for clinical trials, the MCAZ further trains regulatory authorities in the Southern African region. By doing so, it contributes to sustainable local competence development. Strengthening MCAZ as an RCORE is an important project pillar of VaccTrain. The aim is to consolidate the transfer of standardised regulatory knowledge to colleagues in the region in a sustainable way – independently from the project.
Two well-experienced regulators from MCAZ qualified for the RCORE trainers’ course organised by VaccTrain 2.0 in September 2024. During their stay, they learnt first-hand about the processes involved in assessing clinical trial applications and monitoring the safety of medicines at the PEI and at European level. Experts from the pharmacovigilance department explained how they process, track and evaluate adverse drug reaction reports. In addition, they shared insight on which databases they use and how the exchange at European level works. Finally, they illustrated how the PEI ensures through inspections that marketing authorisation holders have a functioning adverse drug reaction early warning system in place. The two trainees from Zimbabwe emphasised that the exchange with VaccTrain 2.0 and other PEI experts, their experiences and all the practical tips and documents shared during the training were very useful for their work at MCAZ and as RCORE trainers.
In addition to imparting knowledge, the train-the-trainer course also includes the development of didactic materials for knowledge transfer to the home region. By taking part in the VaccTrain 2.0 train-the-trainer courses, the participants committed to providing training to their colleagues. Towards the end of their stay at the PEI, the trainees prepared their own presentations on what they had learnt and presented them to the PEI team. Dr Olga Rassokhina of VaccTrain 2.0 was delighted with the quality of the presentations. She says, ‘The selected content was presented in a very clear, structured and comprehensive way and transferred to the trainees’ own context. It is really very enriching to have such great project partners with us.’
Another train-the-trainer with three authorities boosts networking
At the end of May 2024, VaccTrain 2.0 conducted a train-the-trainer course at the PEI with three regulators from West Africa. The VaccTrain contact persons from the regulatory authorities of The Gambia, Liberia and Sierra Leone took part. The course also focused on the approval and monitoring of clinical trials and drug safety, with training content tailored to the needs of the three authorities. Again, it was agreed that the trainees would train their colleagues in the home authorities with the knowledge they had acquired.
Another outcome of this train-the-trainer course is that the three trainees advocated formalised cooperation between their three authorities on clinical trials and pharmacovigilance. Besides, they intend to take the initiative in their authorities for this purpose. Dr Juwe D. Kercula, Manager at the Department for Clinical Trials & Pharmacovigilance at the Liberia Medicines & Health Products Regulatory Authority (LMHRA) said the training provided an opportunity to strengthen the network between the three West African authorities. This was his first visit to PEI and he emphasised that it was an insightful and great experience for him. He especially appreciated learning about the adverse drug reaction reporting system in Germany and Europe.
Ongoing technical support to the three partners
In addition to capacity building through training, an important component of VaccTrain 2.0 is to provide technical support to the partner countries Liberia, Sierra Leone and The Gambia. The intent is to develop and revise the necessary regulatory documents. The work on regulations, guidelines, forms and checklists, is an ongoing task for the country teams in this phase of the project. This particularly concerns exercising drug safety and good clinical practice inspections. Once these documents have been approved and implemented, the authorities will have a more stable and better functioning basis for protecting the safety and rights of patients. They are further essential for licensing and monitoring urgently needed and effective vaccines.
Key Facts:
Train-The-Trainer 1/2024:
Title: GHPP Train-the-Trainer Fellowship for African Regulators at the Paul-Ehrlich-Institut on Pharmacovigilance System and Clinical Trials Regulation in Germany and the European Union.
Participants: Three regulators from the MCA, The Gambia, LMHRA Liberia and Pharmacy Board of Sierra Leone (PBSL) in Sierra Leone.
Place and time: Langen, 27 May – 7 June 2024
Train-the-Trainer 2/2024:
Title: GHPP Train-the-Trainer Fellowship for African Regulators at the Paul-Ehrlich-Institut on Pharmacovigilance System and Clinical Trials Regulation in Germany and the European Union.
Participants: Two regulators from the MCAZ Zimbabwe
Place and time: Langen, 16 September – 27 September 2024
