FDA TO REVIEW ‘RCORE’ TRAINING MANUAL FOR CLINICAL TRIALS REGULATION WITH SUPPORT FROM GIZ



The Food and Drugs Authority Ghana (FDA) with funding support from the German Development Cooperation Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH has put together a team of experts to review its Regional Centre for Regulatory Excellence (RCORE) manual on clinical trials oversight. The manual is to reflect new recommendations from stakeholders after four years of its piloting in collaboration with the School of Public Health, University of Ghana, Legon and the Paul Ehrlich-Institut.


The FDA is mandated by the Part 8 of the Public Health Act, 2012 Act 851 to regulate the conduct of clinical trials through the implementation of appropriate and modern regulatory measures to achieve the highest standard for the design, conduct, recording and reporting of clinical trials in Ghana.


RCOREs aim to improve the safety and quality of health technologies by strengthening regulatory capacity in African Union member states and thus the need to bring together a team of experts to review the current training manual

The RCORE manual, a training manual that seeks to fill knowledge gaps was developed for NEPAD-designated RCOREs with clinical trial oversight to deliver training programs for regulatory personnel across National Regulatory Agencies in Africa.


The manual which is a strategic and tactical training tool has detailed content ranging from perspectives on drug development, clinical trial protocol development, trial design and GCP Inspections, identifying roles and responsibilities, trial management, quality assurance in clinical trials, adverse events and safety monitoring as well as reporting from clinical trial sites


In 2014, Ghana’s FDA was designated as a Regional Centre of Regulatory Excellence (RCORE) by NEPAD (now AUDA-NEPAD) to build capacity and enhance the skills of regulators and researchers in effective and quality clinical trial regulation through hands-on training and exchange programs.

This designation provides a platform to share knowledge and experience with other regulatory authorities in sub-Saharan Africa by offering capacity-building programmes since 2017.


So far 54 African regulators have been trained under the RCORE fellowship program and the FDA aims to train more regulators in the coming years to significantly enhance the workforce for Clinical Trial regulation in Africa which include regulators from non-English speaking countries in Africa.

The experts were drawn from the School of Public Health, University of Ghana, Paul Ehrlich Institute, a medical regulatory body from Germany and the Food and Drugs Authority.



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