As part of activities geared towards dissemination and exploitation of the results or impact of the EDCTP-sponsored BERC-Africa Project, the FDA took the opportunity to speak about the BERC-Africa project at the 2022 (3rd) edition of the Impact Africa Summit (IAS) which was organized in Lagos Nigeria from 1st – 3rd December 2022.
The Impact Africa Summit (IAS) is a high-level international pharmaceutical and clinical trial conference that seeks to bring together key healthcare stakeholders in Africa and beyond for the purpose of improving healthcare in Sub-Saharan Africa through dialogue, exchange, and networking between the public and private sectors at forums. The summit was organized by Xcene Research, an African Contract Research Organization (CRO) committed to providing clinical trials access to a more diverse population in Africa.
The three-day summit was held under the theme, “Clinical Trials Diversity with Inclusion of Africa: Achieving Clinical Research Equity, A Key Step Towards Healthcare Innovation in Africa’’ with the following objectives:
Dialogue among critical stakeholders in the healthcare and the pharmaceutical industry in improving health systems and the health status of patients in Sub-Saharan Africa.
Collaboration with key partners locally and globally to make an urgent paradigm shift towards harnessing the power of science, research innovation and technology for strengthening systems for promoting health and disease prevention.
The FDA Ghana was invited to participate and give two presentations during the 3-day summit.
On the first day of the summit was a conference where many experienced speakers involved in healthcare and research across the globe were given the opportunity to speak on diverse topics. A presentation was given by Mrs. Amma Frempomaa Asare, the BERC-Africa Project Training Coordinator and Senior Regulatory Officer at the Clinical Trials Department at FDA on the topic, ‘’The Blueprint of the African Regulatory Framework – Building Capacity in Clinical Trials Within SSA and Enhancing Access to Medicine by Harmonizing Regulatory Requirements.’’ In her presentation, she touched briefly on the FDA’s mandate in Clinical Trials, and the tools used in the regulation of trials in Ghana (guidelines, application and assessment forms, site progress and close-out reporting forms, as well as Standard Operating Procedures). She indicated that as part of the best practices, building the capacity of relevant stakeholders in clinical trials can be achieved through stakeholder engagements/meetings and trainings. She mentioned that the FDA in its quest to improve harmonisation of regulatory requirements within Africa is making great strides through mentorship programmes and trainings for African regulators such as the RCORE Fellowship Programme in clinical trial oversight.
On the second day, Mrs. Asare gave another presentation at the regulatory forum on the topic, ‘’Ghana FDA's Success in Increasing Capacity of Clinical Trials in Africa: Challenges Encountered and Solutions to Standardize Regulatory Framework Across Africa.’’ She highlighted some challenges the FDA had encountered over the years of regulating clinical trials in Ghana as
Lack of some local stakeholders’ appreciation of clinical trial regulation.
Conduct of trials without requisite regulatory approval, protocol violations and deviations by study teams.
Inadequate capacity-building in key areas of clinical trial regulation such as biostatistics.
Disparities between African countries with respect to regulatory capacities and language barrier between English and non-English-speaking clinical trial stakeholders.
In solving these problems, Mrs. Asare pointed out the need for continuous capacity-building activities such as stakeholder engagements and GCP trainings for clinical research teams as well as regulators. She took the opportunity to elaborate on the great achievements the FDA had so far made with the RCORE Fellowship Training for African regulators. She indicated that to address the issue of language barrier, the FDA had for the first time since the commencement of the RCORE Fellowship Training Programme in 2017, included regulators from French-speaking countries in August 2022. The training was organized with sponsorship from the European and Developing Countries Clinical Trials Partnership (EDCTP) as part of capacity-building activities under a 3-year project, Building and Enhancing Regulatory Capacity in Africa (BERC-Africa). Almost 70 African regulators have so far been trained under the fellowship programme.
Mrs. Asare took the opportunity to briefly talk about the other capacity-building activities/trainings programmes under the work packages of this all-important EDCTP-sponsored project project. She indicated that these activities had been carefully selected or designed to provide African regulators the technical know-how in quality review/assessment of trial applications in addition to enabling them set up the requisite systems and structures to ensure regulatory compliance in the conduct of clinical trials in their respective countries.
During the summit, some notable recommendations or proposals which were made by participants to help improve the regulation of clinical trials in Africa include:
Shorter timelines for reviewing clinical trial applications.
Electronic submission of applications and other related documents in a harmonized way across African countries.
The need for African countries to partner together to develop laboratories that can process biological samples from clinical trials to avoid shipping these samples outside Africa.
Sponsors should be encouraged to conduct pre-submission meetings.
In a nutshell, the Impact Africa Summit was a success as it was very informative and insightful. It provided the FDA Ghana with an opportunity to share the impact of the EDCTP BERC-Africa project on improving the regulation of clinical trials in Africa through capacity-building activities.
Amma Asare, BERC-Africa Training Coordinator, giving a PowerPoint Presentation at the Conference on Day 1
Amma Asare, BERC-Africa Training Coordinator, giving a PowerPoint Presentation at the Regulatory Forum
Panel Discussions during the IAS Regulatory Forum
Panel Discussions during the IAS Regulatory Forum
Participants during the Conference on the first day of the summit
Panel Discussions at the IAS Regulatory Forum