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\begin{document}

\title{Needs driven talent and competency development for the next generation
of regulatory scientists in Africa}



\author[1]{Boitumelo Semete-Makokotlela}%
\author[2]{Gugu Mahlangu}%
\author[3]{David Mukanga}%
\author[4]{Delese Darko}%
\author[5]{Peter Stonier}%
\author[6]{Luther Gwaza}%
\author[1]{Portia Nkambule}%
\author[7]{Precious Matsoso}%
\author[8]{Regine Lehnert}%
\author[9]{B Rosenkranz}%
\author[10]{Goonaseelan Pillai}%
\affil[1]{South African Health Products Regulatory Authority}%
\affil[2]{Medicines Control Authority of Zimbabwe}%
\affil[3]{Bill \& Melinda Gates Foundation}%
\affil[4]{Food and Drug Authority Ghana}%
\affil[5]{King's College London Faculty of Life Sciences and Medicine}%
\affil[6]{World Health Organization}%
\affil[7]{Health Regulatory Science Platform}%
\affil[8]{Federal Institute for Drugs and Medical Devices}%
\affil[9]{Stellenbosch University Department of Medicine}%
\affil[10]{CP Plus Associates}%


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  \date{May 26, 2024}


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\begin{abstract}
There is a critical skills gap on the African continent in regulatory
sciences, and an acknowledged need to develop a long-term strategy for
training and professional development of African regulatory personnel.
Capacity building programs for African regulators should link education,
training and research with career development in an approach that
combines an academic base and experiential learning aligned within a
competency framework. A regulatory ecosystem that engages with a broad
range of stakeholders will mean that expertise in the ever-expanding
field of regulatory science filters into teaching and research in a
symbiotic way. In this way capacity development interventions will be a
collaborative approach between the learning context (academic and
training institutions) and the performance context (regulatory agencies
and industry), which will ultimately best serve the patients. Monitoring
and evaluation of capacity development interventions will be essential
to show value of investments and ultimately guide continued funding and
sustainability. This paper reviews the skills and human capacity gap and
outlines a staged tactical approach for Africa that builds on previous
efforts to strengthen African regulatory ecosystems.%
\end{abstract}%



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