The African Regulatory Leadership Programme

Grant number: 312446/Z/24/Z

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2024
    2026
  • Known Financial Commitments (USD)

    $1,019,868.96
  • Funder

    Wellcome Trust
  • Principal Investigator

    Dr. MARGARETH NDOMONDO-SIGONDA
  • Research Location

    South Africa
  • Lead Research Institution

    Wits Health Consortium (Pty) Ltd
  • Research Priority Alignment

    N/A
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Therapeutics logistics and supply chains and distribution strategies

  • Special Interest Tags

    N/A

  • Study Type

    Not applicable

  • Clinical Trial Details

    N/A

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

In response to the COVID-19 pandemic, the political leadership of the African Union undertook to invest in local manufacturing capacity for vaccines, therapeutics and diagnostics, through the Partnership for African Vaccines Manufacturing Framework. The framework aims to locally produce 60% of vaccines needed on the continent by the year 2040, building on a sound regulatory environment established through the African Medicines Regulatory Harmonization Initiative and the African Medicines Agency. A competent Chief Executive Officer and the Executive Management Team of a national regulatory authority (NRA) are the driving force for accelerating organizational development towards stable, well-functioning and integrated national regulatory systems for medical products as recommended by the World Health Organization Benchmarking Tool. The African Regulatory Leadership Project-a recommendation of the Future of Health and Economic Resilience of Africa (FHERA) initiative-will be jointly led by Wits RHI, the largest research institute at the University of the Witwatersrand, and the Harvard T.H. Chan School of Public Health. The project goal is to increase the African NRAs senior executives' leadership capacity to provide oversight on the medical products' regulatory ecosystem. Two Cohorts of thirteen CEOs each will be piloted through a 4-days face-to-face interaction followed by a 6-months mentorship programme.