During the year, two regulatory staff from the FDA Ghana undertook a ‘Train-the-Trainer’ regulatory attachment in Germany at the Paul Ehrlich Institute. The trainees play leading roles as trainers in FDA Ghana’s RCORE clinical trials fellowship training programme. The training was originally scheduled to be a 45-day on-site training at the Paul Ehrlich Institute but, due to the pandemic, it was ultimately delivered in two parts: a two-week online theoretical part and a four-week practical, hands-on session in Germany. An additional 23 regulators from the FDA Ghana (and other regulatory authorities in Africa) took part in the virtual theoretical sessions.

This high-level training and consulting programme from the Ghana RCORE for Clinical Trials was specifically designed to build their regulatory skills and knowledge, particularly in the area of evaluating clinical trial applications and monitoring the benefit–risk balance of vaccines and biologics.

In November–December 2022, the Ghana FDA also held its first advanced RCORE fellowship training in clinical trials, in collaboration with the University of Ghana and with support from the New Partnership for Africa’s Development (AUDA-NEPAD). Regulatory officers from national medicine regulatory authorities in The Gambia, Liberia, Nigeria, Sierra Leone, Tanzania, Uganda and Zambia attended the training.

A wide range of training activities were organised under the umbrella of the BERC-Africa project in 2022. In August 2022, the Food and Drugs Authority (FDA) Ghana, a designated Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials Regulation in Africa, organised a fifth round of clinical trials fellowship training, in collaboration with the University of Ghana. The training was originally intended for 10 participants, but 15 African regulators were ultimately trained thanks to additional sponsorship from the Paul Ehrlich Institute, Germany. For the first time since its inception, the training had six francophone participants.

The RCORE training aims at building capacity in clinical trials within the sub-region to enhance the conduct of clinical trials and improve access to medicine by harmonising regulatory requirements. The intensive 4-week programme was attended by participants from Benin, Cameroon, Gabon, The Gambia, Ghana, Guinea Conakry, Kenya, Liberia, Nigeria, Rwanda and Senegal.

As well as covering all key areas of clinical trial regulation, the training included a practical regulatory attachment where participants gained hands-on experience on clinical trials authorisation and Good Clinical Practice (GCP) inspections.