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Needs driven talent and competency development for the next generation of regulatory scientists in Africa
  • +8
  • Boitumelo Semete-Makokotlela,
  • Gugu Mahlangu,
  • David Mukanga,
  • Delese Darko,
  • Peter Stonier,
  • Luther Gwaza,
  • Portia Nkambule,
  • Precious Matsoso,
  • Regine Lehnert,
  • B Rosenkranz,
  • Goonaseelan Pillai
Boitumelo Semete-Makokotlela
South African Health Products Regulatory Authority
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Gugu Mahlangu
Medicines Control Authority of Zimbabwe
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David Mukanga
Bill & Melinda Gates Foundation
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Delese Darko
Food and Drug Authority Ghana
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Peter Stonier
King's College London Faculty of Life Sciences and Medicine
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Luther Gwaza
World Health Organization
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Portia Nkambule
South African Health Products Regulatory Authority
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Precious Matsoso
Health Regulatory Science Platform
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Regine Lehnert
Federal Institute for Drugs and Medical Devices
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B Rosenkranz
Stellenbosch University Department of Medicine
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Goonaseelan Pillai
CP Plus Associates
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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.

Peer review status:UNDER REVIEW

23 Feb 2021Submitted to British Journal of Clinical Pharmacology
23 Feb 2021Submission Checks Completed
23 Feb 2021Assigned to Editor
25 Feb 2021Reviewer(s) Assigned
29 Mar 2021Review(s) Completed, Editorial Evaluation Pending
06 Apr 2021Editorial Decision: Revise Major
18 May 20211st Revision Received
19 May 2021Submission Checks Completed
19 May 2021Assigned to Editor
19 May 2021Review(s) Completed, Editorial Evaluation Pending
26 May 2021Reviewer(s) Assigned