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Needs-driven talent and competency development for the next generation of regulatory scientists in Africa.
Semete-Makokotlela, Boitumelo; Mahlangu, Gugu N; Mukanga, David; Darko, Delese Mimi; Stonier, Peter; Gwaza, Luther; Nkambule, Portia; Matsoso, Precious; Lehnert, Regine; Rosenkranz, Bernd; Pillai, Goonaseelan Colin.
Affiliation
  • Semete-Makokotlela B; South African Health Products Regulatory Authority, Pretoria, Gauteng, South Africa.
  • Mahlangu GN; Medicines Control Authority of Zimbabwe, Harare, Zimbabwe.
  • Mukanga D; Bill & Melinda Gates Foundation, Seattle, USA.
  • Darko DM; Food and Drugs Authority, Accra, Ghana.
  • Stonier P; Pharmaceutical Medicine Department, Institute of Pharmaceutical Sciences, Faculty of Health Sciences and Medicine, Kings College London, UK.
  • Gwaza L; World Health Organization, Geneva, Switzerland.
  • Nkambule P; South African Health Products Regulatory Authority, Pretoria, Gauteng, South Africa.
  • Matsoso P; Department of Pharmacy & Pharmacology, Faculty of Sciences, University of the Witwatersrand, South Africa.
  • Lehnert R; GHPP-PharmTrain project, Federal Institute for Drugs and Medical Devices (BfArM), Germany.
  • Rosenkranz B; Fundisa African Academy of Medicines Development, Cape Town, South Africa.
  • Pillai GC; Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Br J Clin Pharmacol ; 88(2): 579-586, 2022 02.
Article de En | MEDLINE | ID: mdl-34346098
ABSTRACT
Capacity building programmes 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 gaps, reports on regulatory assessment pathways used in Ghana, South Africa and Zimbabwe and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.
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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Médecins / Écosystème Limites: Humans Pays/Région comme sujet: Africa Langue: En Journal: Br J Clin Pharmacol Année: 2022 Type de document: Article Pays d'affiliation: République d'Afrique du Sud

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Médecins / Écosystème Limites: Humans Pays/Région comme sujet: Africa Langue: En Journal: Br J Clin Pharmacol Année: 2022 Type de document: Article Pays d'affiliation: République d'Afrique du Sud
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