About BERC-AFRICA 

Learn about BERC-AFRICA, its objectives and more

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Building and Enhancing Regulatory Capacity in Africa (BERC-Africa)

The rapid geographic spread of infectious diseases is a major public health concern that can be arrested by increasing the pace and efficiency of related clinical trials. In recognition of this need Food and Drugs Authority (FDA) Ghana sought to bolster the capacity of African regulators in the area of clinical trials.   

In April 2020 the FDA received favorable response to its application to the European and Developing Countries Clinical Trials Partnership (EDCPT) for clinical trial capacity building.

The project, Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) was officially commenced on 1st October 2020 with FDA Ghana as the lead implementer with support from the University of Ghana School of Public Health (UG SPH), Legon, Kumasi Centre for Collaborative Research (KCCR), Paul Ehrlich Institut (PEI) and the Coalition for Epidemic Preparedness Innovation (CEPI).

OUR OBJECTIVES

i

Train regulators from National Medicines Regulatory Agencies (NMRAs) under the Regional Centre of Regulatory Excellence (RCORE) Fellowship Training in Clinical Trials, including those from Francophone countries.

ii

Train regulators from National Medicines Regulatory Agencies (NMRAs) under the Regional Centre of Regulatory Excellence (RCORE) Fellowship Training in Clinical Trials, including those from Francophone countries.

iii

Train regulators from National Medicines Regulatory Agencies (NMRAs) under the Regional Centre of Regulatory Excellence (RCORE) Fellowship Training in Clinical Trials, including those from Francophone countries.

SPONSORING PARTNER

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public-public partnership between countries in Europe and sub-Saharan Africa, supported by the European Union. 

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COLLABORATING PARTNERS

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Food and Drugs Authority

Provide technical coordination as well as financial and administrative management to accomplish the objectives of the project. 

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University of Ghana School of Public Health (UG SPH)

Provide resource persons for the theoretical session of the RCORE Fellowship Training Programme in Clinical Trials. 

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Kumasi Centre for Collaborative Research (KCCR) into Tropical Medicine, KNUST

Provided a potential site for GCP inspection during the RCORE Fellowship Training

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Paul-Ehrlich-Institute

Serve as the host institute for regulatory attachment for RCORE trainers.  

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Coalition for Epidemic Preparedness Innovation 

Provide a resource person for regulatory training in first-in-human and early phases of vaccine clinical trials, complex and adaptive designs in clinical trials. 

EXPECTED IMPACT

  • Following the implementation of the project, regulators will have enhanced regulatory skills and knowledge in quality assessment and compliance monitoring of clinical trails applications.

  • In the long run this would ensure the credibility of results or data collected in the conduct of clinical trials in Africa, leading to informed decision making for public health related issues and improvement in human health.