Pharmacometrics Africa, in collaboration with SAHPRA and the Department of Pharmacy and Pharmacology at the University of the Witwatersrand, marks the graduation of the fourth cohort of the Clinical Assessors Short Course — a programme designed to strengthen regulatory capacity across Africa.
This 14-week certified course is part of an ongoing effort to build technical knowledge in assessment of clinical sections of regulatory dossiers. The course has a primary focus on the development of professionals working in African National Regulatory Agencies, while also welcoming private sector regulatory scientists. Accredited by Wits University, the course brings together regulators, academics, patient advocates, and industry stakeholders to promote shared understanding and practical skills in clinical assessment.
The most recent cohort included participants from National Regulatory Authorities in Botswana, Ethiopia, Ghana, Kenya, Namibia, Rwanda, South Africa, Tanzania, Zambia, and Zimbabwe. Their participation reflects a growing interest across the continent in strengthening regulatory systems.
“This training course has once again brought together a diverse group of regulators, academic experts, and industry professionals to engage in honest, solutions-oriented dialogue. The outcomes speak directly to better patient access and improved therapeutic interventions,” added Professor Colin Pillai, CEO of Pharmacometrics Africa.
“As we mark the fourth cycle of this impactful programme, we are reminded that investing in regulatory training is an investment in patient safety. These graduates are shaping a healthier, safer future for the continent,” said Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA.
Professor Yahya E. Choonara of the University of the Witwatersrand emphasised, “We are proud to continue our leadership role in regulatory science education provided by our Pharmacy Practice team and the WITS Pharmacy Regulatory Sciences Hub. This programme not only strengthens technical skills but also fosters cross-border collaboration, vital for regulatory harmonisation in Africa.”
The course curriculum focuses on the evaluation of clinical components in regulatory submissions, with particular attention to risk-benefit assessment. Graduates complete the programme with practical tools intended to support quality, consistency, and timeliness in regulatory decision-making.
Reflections from participants, including those from the private sector, highlighted the value of engaging with both sponsor and regulator perspectives to support better patient outcomes.
You can hear from them and the rest of the stakeholders and faculty in the recorded ceremony:
About
Pharmacometrics Africa:
Pharmacometrics Africa is a not-for-profit company registered in South Africa as a platform for interested groups to establish and run open access quantitative clinical pharmacology educational programs in partnership with local research organizations and academic groups.
About SAHPRA:
SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in-vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).
SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of all who reside in South Africa: Safety, Efficacy and Quality. It is these three pillars that define the ethos of SAHPRA.
About the Department of Pharmacy and Pharmacology at Wits:
The Department of Pharmacy and Pharmacology at the University of the Witwatersrand is home to a dynamic and innovative community of academic and support staff, postgraduates, undergraduates and postdoctoral fellows. As leaders of pharmacy education and research in South Africa, the key areas of pharmaceutical formulation and drug delivery technology, regulatory sciences, pharmaceutical entrepreneurship, management of drug therapy, counselling on the use of medication, monitoring drug therapy outcomes and pharmacology lie at the heart of our activities. We are dedicated to providing high-quality research-led teaching and supervision that can change the world we live in.