Many regulatory agencies across the African continent have been grappling with a critical shortage of skilled professionals due to resource constraints and a paucity of training opportunities. It is this gap that the South African Health Products Regulatory Authority (SAHPRA) and other African agencies highlighted in a paper published in the British Journal of Clinical Pharmacology, and intended to fill when they invited Pharmacometrics Africa to develop Africa-centric training opportunities in the regulatory sciences. Read on to discover what these efforts entailed, or download the report now.
Pharmacometrics Africa and its partner network collaborated with a network of dedicated subject matter experts to proudly conclude the second iteration of their course, “A Primer for Clinical Assessors within African Regulatory Agencies.” This innovative initiative spans over 12 weeks and delivers a comprehensive curriculum aimed at building and refining the essential competencies required by clinical assessors working within regulatory bodies across Africa.
The course takes participants on an intensive journey into assessing the clinical sections of regulatory dossiers with regards to efficacy and safety of new medicines that will be used in Africa. Through a combination of live tutorials and online coursework, participants dive deep into the intricacies of the field. What sets this initiative apart is its holistic approach, focusing on three distinct yet interconnected phases: Construction, Deconstruction, and Reconstruction of the Regulatory Dossier. These stages encompass the entire spectrum of regulatory work, from building robust dossiers to assessing their contents and supporting marketing authorizations.
Recognizing the importance of varied perspectives, the course enlists subject matter experts from both international and regional backgrounds. These experts don’t just deliver weekly lessons; they also contribute to crafting a reusable online curriculum and a repository of resources, ensuring a lasting impact beyond the course itself. The “train-the-trainer” aspect is exemplified by graduates of the program who re-join as faculty members, demonstrating a ripple effect that multiplies the reach of this valuable initiative.
Regulators are nominated from multiple participating agencies, including Ghana Food and Drugs Authority, Kenya’s Pharmacy and Poisons Board, Nigeria’s National Agency for Food and Drug Administration and Control, South African Health Products Regulatory Authority, Tanzania’s Medicines and Medical Devices Authority, and the Medicines Control Authority of Zimbabwe.
The University of Witwatersrand provided certificates of competence to participants who fulfilled the rigorous course completion criteria, thereby adding an academic rigour in addition to personal professional development for the participants. These criteria included lesson attendance, completion of tasks, group exercises, and examination results. The participants’ commitment and hard work were celebrated in a graduation ceremony.
In the spirit of continuous improvement, a robust monitoring and evaluation framework was employed, building upon the success of the pilot course. A comprehensive end-of-course survey not only provided valuable insights into the course’s effectiveness but also highlighted areas for further enhancement. Thanks to further funding from the Bill & Melinda Gates Foundation the course will continue.
Download the report “A Primer for Clinical Assessors within African Regulatory Agencies.