October/November 2023, Bonn Germany

Following the successful virtual launch of the GHPP PharmTrain2 biosimilar fellowship in May 2023, ten fellows from the partner national medicines regulatory authorities (NMRAs) in Ghana, South Africa, Tanzania, and Zimbabwe participated in a three-week workshop in Bonn.

At the opening event, Hiiti Sillo^[1] from the World Health Organization (WHO) advocated the development and promotion of regulatory structures and competencies to strengthen the functionality of NMRAs worldwide. The GHPP PharmTrain2 biosimilar fellowship aims at training trainers and thereby directly contributes to this goal (read more in Capacity Development). The workshop focused on hands-on training in assessing an application dossier under the guidance of BfArM experts. The fellows learned to apply important aspects in the assessment process of biosimilars. Intensive work in small groups led to vivid exchange among the fellows and with various experts from the BfArM. The fellows gained valuable insights into central approval procedures and the role of the European Medicines Agency (EMA) through virtual participation in sessions of the Committee for Medicinal Products for Human Use (CHMP) and the Biologics Working Party (BWP). Beyond the scientific exchange, the fellows demonstrated their motivation to further develop themselves as trainers during training session on didactics and methodology.

A highlight was the symposium on "Regulatory Landscapes in Africa, the EU, and Germany." Together with many BfArM employees, the fellows delved into Africa's regulatory landscape, the establishment of the African Medicines Agency (AMA) and its future continental role. International guest speakers^[2], the CHMP Chair of the EMA^[3] and the Vice President of the BfArM^[4] discussed common goals, opportunities, and challenges for the future of drug approval in Africa and Europe.

At the end of the workshop, a highly motivated and committed group, who are now closely connected both professionally and personally, said goodbye. There is great anticipation of seeing each other again soon for regular online training sessions and further networking across borders and disciplines.

^{[1] Unit Head Regulation & Safety, Department of Regulation and Prequalification, WHO
[2] Dr. David Mukanga & Dr. Mac Lumpkin, Bill & Melinda Gates Foundation; Farai Masekela EMP-TC Chair
[3] Dr. Harald Enzmann, European Union and International Affairs at the BfArM
[4] Prof. Dr. Werner Knöss, Vice President of the BfArM}