The PharmTrain2 Clinical Fellowship is at the forefront of advancing clinical regulatory expertise across Africa. Through a combination of workshops and hands-on training sessions, the programme equips clinical assessors with the skills necessary to optimise regulatory practices and ensure the effective evaluation of medicinal products. This report highlights two key milestones: the recent manual workshop in Tanzania and the first continental clinical assessment training – both of which underscore the fellowship's commitment to capacity-building and harmonization across the African continent.

Manual workshop in Tanzania: progress of the RegX Joint Training Manual for clinical assessment

The fourth onsite workshop of the PharmTrain2 Clinical Fellowship took place from 04-08 November 2024 near Stone Town, Tanzania. Marking the programme's first event outside Germany, this workshop focused on the advancement of a comprehensive training manual tailored for clinical assessors in national medicines regulatory authorities. The joint development of the RegX Joint Training Manual was a key goal of the ten fellows from the regulatory authorities of Ghana (FDA Ghana), Zimbabwe (MCAZ), South Africa (SAHPRA) und Tanzania (TMDA), as well as the PharmTrain team. Until now, nearly 30 training sessions about the clinical evaluation of medicines were developed and tested, including an introduction into the topic along with specific modules about pharmacokinetics. The workshop in Tanzania progressed the modules on the assessment of efficacy and safety studies.

Another key point on the agenda was preparing for the continental training on clinical assessment, scheduled for the subsequent week (for details see below). This event adopts a train-the-trainer approach, with the fellows serving as trainers to teach assessors across Africa. After five days of intense work, significant progress was achieved in the development of the training manual. Modules on assessing the efficacy and safety studies of medicinal products were piloted and collaboratively refined within the group. The fellows demonstrated significant growth in both clinical expertise and teaching abilities since the fellowship's inception and especially during this workshop. Time was further efficiently used to prepare for the upcoming continental training: Parts of the training were practiced, and hands-on exercises were developed to ensure an engaging and practical learning experience for participants. The seed for growing expertise in clinical evaluation and training competence was beginning to sprout.

African assessors are training African assessors in clinical evaluation

Since its inception in 2019, the PharmTrain Clinical Fellowship has been instrumental in fostering a network of skilled clinical assessors, who are equipped with regulatory, scientific and didactic skills to become trainers themselves. The first continental training on clinical assessment was held in Dar es Salaam, Tanzania, involving assessors from 12 African countries and was organized in collaboration with the AUDA-NEPAD. Seven PharmTrain fellows devised and carried out a total of 16 highly interactive and stimulating trainings, where they gathered valuable teaching experiences and refined their teaching materials.

The trainings covered essential modules from the jointly developed training manual: This included strategies and preparation for clinical evaluations, ethical considerations of clinical research and the evaluation of the different types of pharmacokinetic study data crucial for marketing authorization applications. Topics ranged from single and multiple ascending dose and bioavailability to food- and drug-drug interaction studies as well as investigations of the effect of renal or hepatic impairment on the medicine’s exposure. The training featured hands-on training with actual dossiers, blending theoretical knowledge with practical application. By the end of the week, participants showed measured improvements in their understanding of clinical dossier evaluation and the feedback of the participants was overwhelmingly positive.

This training sets the stage for future continental initiatives, emphasizing sustainability and ongoing skill development. By offering a forum for participants to exchange diverse regulatory perspectives, the event fostered supranational collaboration and harmonization.

The GHPP-PharmTrain fellows played a pivotal role, serving as inspiring and efficient trainers. Their achievements attest to years of hard work and the positive results of this training represent the first harvest. It was deeply fulfilling for the fellows and the PharmTrain team as organizers to watch the growth of the South-South collaboration and the consolidation of the success of the fellowship programme.