From Trainees to Trainers: The Journey of the PharmTrain Fellows
The PharmTrain Clinical Fellowship has established a network of skilled trainers who recently delivered the first continental training for clinical assessors. This marks a significant milestone in regulatory capacity development across Africa.
The PharmTrain clinical fellowship involves fellows from the national medicines regulatory authorities (NMRAs) in Ghana, Zimbabwe, Tanzania and South Africa, i.e. from three different economic regions, thus covering large parts of Sub-Sahara Africa. This group committed to an intensive, multi-year journey to acquire both technical expertise and didactic skills within the fellowship of the GHPP PharmTrain and subsequent PharmTrain2 projects. At the heart of this fellowship lies the train-the-trainer concept, ensuring that participants not only gain knowledge and expertise but also develop the ability to effectively share it with others. All activities foster a sustainable approach to capacity development. The fellows engage in monthly online sessions covering a range of clinical topics, complemented by homework assignments requiring an additional time of self-study. An essential highlight of the programme is the annual two-week onsite training at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. At the institute fellows participate in intensive, hands-on learning experiences, including practical dossier assessments and direct interaction with regulatory experts. Despite the demanding workload and long duration, the current group has remained largely intact, evolving into a cohesive and capable team of trainers.
Another major goal of the fellowship is the development of the comprehensive ‘RegX Joint Training Manual on Regulatory Excellence in Clinical Assessment’ designed to serve as a resource for training clinical assessors at national, regional, and continental level. The manual includes professionally designed PowerPoint presentations, extensive facilitator’s notes, and work-related hands-on exercises, enabling structured and impactful training sessions. The individual units of the training manual have been refined through peer review and pilot sessions, proof testing their applicability and improving the quality. While large parts of the manual are nearing finalisation, some units are still under development, with the complete resource scheduled for completion in 2025.
The fellowship’s impact became evident as units from the RegX Joint Training Manual were introduced to broader audiences through trainings at regional initiatives. This included the ZaZiBoNa collaboration in the Southern African Development Community (SADC) region and the West African Health Organization’s Medicines Regulatory Harmonization (WAHO MRH) programme in the Economic Community of West African States (ECOWAS) region. For these initiatives, the fellows conducted training sessions, extending the reach of the training activities to NMRAs, which are not partner institutions of PharmTrain. By selecting the trainers mainly from the other regions than that of the participants, interregional collaboration was fostered.
This progression culminated in the First Continental Training for Clinical Assessors, held in Dar Es Salaam, Tanzania in November 2024. Organised in collaboration with the African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), this event brought together assessors from 12 African countries for one week of intensive training. The PharmTrain-fellows led sessions on topics such as the fundamentals of clinical dossier evaluation and interpreting pharmacokinetic study data. All trainings were based on the RegX Joint Training Manual.
‘I liked most the provision for participation of the trainees; I loved the hands-on exercises, the learning games… Overall, it was fun learning, and the presenters did their best to simplify the process for us!’
Participants provided overwhelmingly positive feedback, emphasising the value of the hands-on approach and the relevance of the training to their regulatory work. Moreover, pre- and post-training assessments revealed a significant overall increase in knowledge on clinical and regulatory topics, with every trainee demonstrating measurable improvement. Plans are already underway for subsequent continental trainings focusing on other topics from the RegX Training Manual, including assessment of efficacy and safety.
So far, this continental training has been a highlight of the Clinical Fellowship, harvesting and enjoying the fruits of the programme. The fellows, who began as trainees, are now equipped to perform and contribute as trainers for clinical assessment in Africa. Their journey demonstrates the fellowship’s effectiveness and underscores its potential to create lasting and meaningful improvements in the clinical capacity of regulatory systems.
