April 2024, Bonn, Germany

Continuing the successful collaboration of previous years, the GHPP PharmTrain team has invited eleven assessors from the National Medicines Regulatory Authorities (NMRAs) in Ghana (FDA), Zimbabwe (MCAZ), South Africa (SAHPRA) and Tanzania (TMDA) to a two-week workshop in Germany as part of the clinical fellowship for the fourth time. This year's workshop focussed on the assessment of pharmacokinetic studies in humans. As in previous workshops, the training was based on a real regulatory dossier. In addition, further sections for the Joint Training Manual were developed. This manual will serve as the foundation for the training of future clinical assessors.

After a warm welcome from the project lead, the coordinators and the head of BfArM’s unit 32, the guided assessment of the efficacy studies begun in the last onsite workshop was resumed and finalised before the focus turned to pharmacokinetic studies. Through keynote presentations on the respective sub-topics, work in small groups and the subsequent intensive exchange in the larger group as well as with the experts at the BfArM, many new learnings were achieved and the newly acquired knowledge was immediately applied in practice. “This approach was very productive”, reported one of the fellows with broad agreement from the others, which reinforced the concept of the workshop.

In anticipation of the continental drug assessment in Africa, which will be piloted this year, the fellows, once again, gained insight into decision-making processes and the underlying scientific exchange in centralised approval procedures in Europe. The group took part virtually in the meetings of the Committee for Medicinal Products for Human Use (CHMP) and the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).

The program was complemented with expert presentations and hands-on exercises on the assessment of drug interactions by BfArM experts. The fellows themselves gave trainings on selected pharmacokinetics topics. These will be included as PowerPoint presentations and facilitator's notes in the training manual described above. These elements rounded off the workshop and emphasised the importance of the comprehensive training and further development of the fellows as trainers for knowledge multiplication on site (train-the-trainer), which is an integral part of the PharmTrain2 project.

It were exciting two weeks in which the opportunities to deepen contacts, learn from each other, inspire, strengthen and trust each other contributed significantly to the success. An exhausted but very satisfied group bid farewell with much praise for the successful workshop and anticipation of next year's visit.