Stakeholder meeting on Regulatory Affairs

The objective of the regulatory affairs stakeholder meeting was to review the current developments, strategies and key players involved the strengthening of regulatory capacity in Africa, to ensure synergy and maximise leverage for joint funding. These include the WHO activities supported by the Gates Foundation; and the African Medicines Regulatory Harmonization (AMRH) initiative implemented through the regional economic communities and countries, spearheaded by the NEPAD Agency). It also aims to address emerging issues that directly impact on EDCTP core activities, such as clinical trial sponsorship, regulatory reviews, and the role of NRAs in pre and post registration safety monitoring of adverse events in clinical trials; and identify priority regulatory areas that may be supported in EDCTP2.

Participants at the regulatory meeting will include representatives from key organisations involved in regulatory strengthening activities in Africa and Europe. This includes WHO, NEPAD Agency, representatives from African and European regulatory agencies, European Medicines Agency, Gates Foundation, PDPs and academic institutions involved in sponsoring clinical trials.

Expected outcomes of the meeting

A report with recommendations to shape the EDCTP strategic and operational business plan was published.

Background reading material

• Dadié Maïga et al., Regulatory oversight of clinical trials in Africa: progress over the past 5 years, Vaccine 27 (2009) 7249-7252
• Dadié Maïga et al., Joint reviews and inspections: Strategic forms of collaboration for strengthening the regulatory oversight of vaccine clinical trials in Africa, Vaccine 28 (2010), 571-575
• Sharing responsibility: Report of the post-registration medicinal products safety monitoring in Africa meeting, 4 November 2012. EDCTP 2012.

Presentations

• Dr Michael Makanga, EDCTP
  Background on EDCTP1 regulatory programme and progress towards EDCTP2
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• Mr Gordon Sematiko (on behalf of Mrs Margareth Ndomondo-Sigonda), African Union NEPAD Agency
  African regulators’ perspective on strengthening regulatory capacity and overview of the African regulatory harmonization process
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• Ms Emer Cooke, European Medicines Agency (EMA)
  How to support regulatory capacity strengthening in sub-Saharan Africa – European perspective
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• Dr Samba Cor Sarr, Senegal National Health Research Council (CNRS)
  AVAREF experience on strengthening regulatory pathway capacity in Africa
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• Dr Delva Shamley, University of Cape Town
  Clinical trials sponsorship by academic and research institutions: Challenges and opportunities – African experience
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• Ms Christine Mathieu, Clinical Trial Center
  Clinical trials sponsorship by academic and research institutions: Challenges and opportunities – European experience
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