Given the ongoing expansion of the healthcare sector, particularly the growth in the clinical trials arena, it has become critical to remain up to speed on developments as well as the industry's constant challenges. The Impact Africa Summit (IAS), as an international pharmaceutical and clinical trial conference, provides a unique forum for the industry's finest experts in regulatory agencies, healthcare organizations, pharmaceutical bodies, and trial sponsors. This is to expand on the importance of collaboration/partnerships across sub-Saharan Africa and experts to engage on designs and systems that deliver transformational healthcare solutions for Africa.
The 4th Edition of the IAS summit was held in Lagos, Nigeria from 30th November 2023 – 2nd December 2023. As was done in the previous year, the FDA took the opportunity to speak about its regulatory capacity-building activities under the EDCTP-sponsored BERC-Africa. This is part of activities geared towards the dissemination and exploitation of the results or impact of the project.
The three-day summit was held under the theme, ‘Strengthening an Emerging Sector in Diverse Markers Through Local Partnerships and Participation.’ The objectives for the 2023 IAS were:
Hear experts in the field talk about issues and discover trends in pharmaceutical research and development. Gain exposure to clinical trial opportunities, therapeutic areas of interest, career opportunities, and regulatory market entry
Make lasting connections with industry experts, leaders, organizations, and peers who are driving research and innovation that is needed to shape the future of healthcare for Africa. Take this unique opportunity to collaborate with business executives, government agencies, investors, and decision-makers to maximize impact
Take part in a celebration to honour those who have impacted healthcare in Africa through cutting-edge research, development, and innovation
Participants and speakers at the summit included representatives from regulatory authorities and policymakers, researchers, scientists, clinical investigators, health tech innovators, and investors and leaders across the globe with in-depth experiences across the healthcare ecosystem – regulatory, healthcare, pharmaceuticals, and medical research. The FDA Ghana was invited to participate in two panel discussions and a presentation during the 3-day summit.
On the first day of the summit, many experienced speakers involved in healthcare and research across the globe were allowed to speak on diverse topics at the conference. Ghana FDA was invited to speak during the second panel discussion on the topic, ‘Enhancing Regulatory Frameworks for Clinical Trials in Africa: Ethically Balancing Global Standards with Local Realities.’ Panelists for this session were Dr. Yvonne Adu Boahen, Head of Clinical Trials Department at Ghana Food and Drugs Authority, Dr. Kwasi Nyarko, Coordinator, AVAREF Secretariat (WHO-AFRO), and Dr Benson Kanji, Product Safety Department, Clinical Trials Division, Pharmacy and Poison Board (PPB) Kenya. During discussions, emphasis was placed on the need to ensure faster timelines for the review of CT applications by African NRAs. This could be achieved if the quest for harmonization of regulatory requirements in Africa is continuously pursued. Dr Adu Boahen mentioned briefly the FDA’s quest to support the bid for harmonization of Clinical Trial requirements in Africa under the EDCTP-sponsored BERC-Africa Project. In addition, a call was made for African NRAs to activate the use of reliance in their local review processes. In such situations, decisions taken by well-resourced and stringent regulatory authorities (WHO Maturity level 3 or 4) on multi-country CT applications may be considered in their review procedures to shorten timelines.
The second day of the summit began with a presentation from Ghana FDA on, ‘Post-Marketing Authorization (PMA) Pathways in African Clinical Trials’ which was delivered by Mrs. Amma Frempomaa Asare, a Senior Regulatory Officer and the Training Coordinator for the EDCTP-sponsored BERC-Africa Project. She indicated that medicinal products are approved based on available data from clinical trials. In most cases, these trials involve a few hundred and on rare occasions, a few thousand. The limited number of patients included in clinical trials, the exclusion of certain patients/populations at-risk, the lack of significant long-term treatment experience and the limited data from concomitant therapies, do not allow a thorough evaluation of the safety profile of these products. Hence, a need to specify post-marketing authorization requirements/pathways for approved products. She briefly went through the requirements and commitments from sponsors following the MA of their products using Ghana FDA’s regulatory requirements. Mrs. Asare mentioned some challenges African NRAs face in PMA of medicinal products which include inadequate resources and infrastructure, technical capacity and expertise, data collection and reporting systems, patient recruitment and retention in post-approval studies, etc. Solutions to these problems include harmonization of regulatory requirements, robust regulatory systems and quality and accessible electronic health records.
Another important solution is capacity building and sensitization of relevant stakeholders and with this, Mrs. Asare took the opportunity to talk about the FDA’s contribution towards regulatory capacity building and harmonization of regulatory requirements in Africa under NEPAD’s RCORE initiative. She indicated that the FDA, in 2020 secured a grant from the European and Developing Countries Clinical Trials Partnership (EDCTP) for capacity-building programmes (relevant short courses and regulatory attachment) under a 39-month BERC-Africa Project. About 45 African regulators from over 15 countries were beneficiaries of the training programmes. Finally, she concluded by saying that collaborative efforts between all relevant stakeholders are necessary to strengthen regulatory frameworks for PMA pathways to ensure the safety and efficacy of medical products in Africa.
Dr. Yvonne Adu Boahen, was invited as a panelist to speak on the issue, ‘Capacity building for regulators: Fostering expertise to meet the growing demands of clinical research in Africa,’ on the second day of the summit. Here, panelists emphasized the importance of ensuring that regulators have the requisite capacity-building programmes that are necessary to equip them to carry out their mandates in the evolving landscape of clinical trials. Regulation is dynamic and therefore changes in trends for conducting clinical trials, call for accompanying regulatory requirements/laws to meet these demands.
During the summit, some notable recommendations or proposals which were made by participants to help improve the regulation of clinical trials in Africa include:
African NRAs should develop and activate reliance pathways, especially in the regulation of clinical trials as one of the solutions to shorten clinical trial review and approval processes
Collaboration in capacity-building activities
AVAREF and CT sponsors to find a way to compensate CT assessors as a means of motivating them for the tight timelines/schedules for assessing applications
The Impact Africa Summit was a success as it was very informative and insightful. It provided a platform for participants to network with industry experts, organizations, and peers, and learn about some current issues and trends in pharmaceutical research and development. Finally, it also 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.
Ghana FDA’s nominated regulators for the 2023 Impact Africa Summit, Dr. Yvonne Adu Boahen and Mrs. Amma Frempomaa Asare.
Dr Adu Boahen (2nd from Left) with others in a Panel Discussion at the IAS Regulatory Forum on Day 2 of the Summit.
Amma Asare, giving a PowerPoint Presentation at the Regulatory Forum on Day 2 of Summit
Dr. Yvonne Adu Boahen receives an award in recognition of her outstanding commitment to healthcare excellence in sub-Saharan Africa.