Successful Regional Training on Bioequivalence Study Assessment Held in Nairobi
June 2025, Nairobi
Since 2019, the PharmTrain project has trained assessors from its partnering national medicines regulatory authorities in the clinical assessment of marketing authorisation applications. Over the past years twelve colleagues from Ghana (FDA Ghana), South Africa (SAHPRA), Tanzania (TMDA ), and Zimbabwe (MCAZ) have expanded their expertise. Key to the PharmTrain2 clinical fellowship is the train-the-trainer principle to ensure efficient, sustainable knowledge transfer and strengthen the South-South collaboration. Three of the fellows had the opportunity to apply their skills in practice during a workshop on the assessment of bioequivalence studies in Nairobi, Kenya. A training manual, comprised of presentations and trainers’ guidance notes, which has been developed jointly by the fellows and the PharmTrain team since 2023, served as the basis for this training.
Especially for low- and middle-income countries, generics are a key component to improve access to healthcare since they are usually less expensive due to reduced developmental costs. Evaluating bioequivalence studies for the regulation of generics requires specific expertise and the workshop in Nairobi was designed to build and strengthen this critical knowledge.
The five-day workshop was organised by the PPB Kenya in partnership with the PharmTrain2 project, part of GHPP. The training was performed by fellows of the clinical fellowship and facilitated by the PharmTrain team. A total of 14 assessors from the national medicines regulatory authorities of Kenya, Egypt, Ethiopia, Rwanda, Tanzania, Uganda, and Zanzibar took part. The group included both experienced and newer staff, creating a vibrant learning environment and enabling regional collaboration.
Participants were taught on a wide range of topics, including Good Clinical Practice and ethics, clinical study design, statistical methods, biowaivers, bioanalytical method validation and data integrity. Besides presentations, the trainings consisted of group exercises, quizzes, reporting sessions and hands-on work with actual dossiers. A pre- and post-test demonstrated that every participant improved his/her knowledge in the field of bioequivalence, with some participants improving their test results by nearly 50%.
What I valued most about the training was the opportunity to engage directly with fellow African assessors and international experts in the field. This exposure not only broadened my understanding of how bioequivalence assessments are approached across the continent but also emphasised the importance of network.
This training has strengthened my commitment to contributing to improved medicines regulation and access in Africa.
Quotes from two participants
The workshop concluded with many heartfelt goodbyes, the exchange of contact details and the expressed wish for more trainings like this one. After an intense week of dedicated learning, the participants looked forward to passing on their newly gained skills in their respective national authorities. The fellows of the clinical fellowship and the PharmTrain team were deeply satisfied to witness the participants’ growing confidence in performing assessments, as well as the growth of the South-South collaboration.
