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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

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.

The Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) Project is a project funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) to build regulatory capacity in Africa. As part of the capacity-building activities under Work Package 3 of this project, an Officer of the Clinical Trials Department at the Food and Drugs Authority (FDA), Ghana, Amma Frempomaa Asare, was nominated to attend an Introductory Course in Epidemiology & Medical Statistics. To be well-equipped as regulators offering training to others, there is a need for officers of the Clinical Trials Department at the FDA to be trained in areas relevant to the regulation of clinical trials. Activities under Work Package 3 of this project were geared towards capacity-building programmes necessary for the professional development of FDA Officers who are RCORE trainers and assessors of clinical trial applications. The Introductory Course in Epidemiology & Medical Statistics is a 3-week intensive short course organized by the London School of Hygiene and Tropical Medicine (LSHTM). The 2023 session of the training took place from 26th June 2023 to 14th July 2023. The course is structured to enable students understand the design and interpretation of epidemiological studies as well as the statistical methods underpinning many of the founding principles in epidemiology. An understanding of epidemiology (the distribution, occurrence, and causes of disease in populations) along with medical statistics, serves as the quantitative foundation for public health. This is relevant because obtaining, interpreting, and using health information helps to reduce illness and disability as well as increase health and well-being among populations. The training took the form of theoretical sessions delivered through PowerPoint presentations and hands-on practicals/assignments in the form of group breakout sessions and discussions. There was a course evaluation at the end of each topic and an overall course evaluation on the last day of the training. This enabled participants to make some recommendations to enhance future trainings Certificates of participation were also issued to participants. Due to the lengthy duration and the intense nature of the course, there were some social activities which were planned by the organizers to help participants relax, socialize and enjoy some tourism in London. Places visited included the Thames, the London Eye, and the historical John Snow Pump where epidemiology is known to have begun. At the end of the course, students gained more understanding of the common pitfalls associated with study designs, enabling them to choose the most appropriate analytical methods to verify stated hypotheses in studies and undertake basic statistical analysis. Ms. Amma Asare (L) and a colleague participant (R) at LSHTM Ms. Amma Asare (L) and her colleague participants in a tour of the Thames A ride in the London Eye Ms. Asare stands beside the water pump which John Snow in 1854 discovered was the source of the contaminated water responsible for the cholera outbreak in the Soho region in London.

As part of the capacity-building activities under Work Package 3 of the Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) project, two officers of the Clinical Trials Department at the Food and Drugs Authority (FDA), Jesse Kojo Kuntoh and Pearl Entsua-Mensah, were nominated to attend a course on Essentials of Clinical Trials. The BERC-Africa Project is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP). The training which was organized by the London School of Hygiene and Tropical Medicine and planned for Year 3 of the Project came off as scheduled. Activities under Work Package 3 of the project are geared towards capacity-building activities necessary for the professional development of FDA Officers who are RCORE trainers and assessors of clinical trial applications. The Essentials of Clinical Trials Training is an intensive and comprehensive one-week course/programme which is designed to equip healthcare professionals, researchers, and individuals involved in clinical research with the fundamental knowledge and skills essential for the successful planning, execution, and evaluation of clinical trials. Clinical trials are pivotal and indispensable in advancing medical knowledge, informing evidence-based practice, and ensuring the safety and efficacy of healthcare interventions. Students were expected to understand the common pitfalls associated with study designs, be able to choose the most appropriate type of trials and ensure that the data churned out of such trials is credible. This training therefore serves as a cornerstone in fostering a deep understanding of the intricacies and ethical considerations surrounding clinical trials. The two nominees from Ghana FDA took part in the training from 3rd to 7th July 2023. The training was virtual and took the form of theoretical sessions delivered through PowerPoint presentations and hands-on practicals/assignments in the form of group breakout sessions and discussions. There was an overall course evaluation on the last day of the training. This enabled participants to make some recommendations to enhance future training. At the end of the course, the training provided a holistic understanding of clinical trials, encompassing both theoretical and practical aspects. Participants were exposed to diverse trial designs and the global perspectives broadened the officers' outlook on clinical trial methodologies which is essential in the understanding and discharge of their duties. Jesse Kojo Kuntoh, a regulator at Ghana FDA and participant in the July 2023 Essentials of Clinical Trials Training organized by LSHTM, a training funded by the EDCTP-under the BERC-Africa Project. Pearl Entsua-Mensah, a regulator at Ghana FDA and participant in the July 2023 Essentials of Clinical Trials Training organized by LSHTM, a training funded by the EDCTP-under the BERC-Africa Project.

The Ghana Food and Drugs Authority (FDA) in collaboration with the School of Public Health of the University of Ghana and support from AUDA-NEPAD recently held its maiden Advanced RCORE Fellowship training in Clinical Trials from 28th November to 10th December 2022 at the MJ Grand Hotel at East Legon, Accra-Ghana. Participants of the training were regulatory officers from National Medicine Regulatory Authorities in Liberia, Nigeria, Sierra-Leone, Zambia, Uganda, The Gambia and Tanzania. The Advanced RCORE training sought to equip NMRA officers with the requisite knowledge and capacities needed to enhance the conduct of clinical trials in Africa, thus make provision for access to quality, safe and efficacious medication, medical devices and health claimed products in Africa. Some topics treated during the training include Clinical Trial Protocol Development, Introduction to Immunology, Safety in Clinical Trials, Basics in Biologics & Vaccines, Assessment of Statistical Analysis amongst many others. For more information on the training, click on the link below: https://www.youtube.com/watch?v=wTBCqGS9DFg Below are some images from the training.

With this training, the Paul-Ehrlich-Institut (PEI) – through the GHPP VaccTrain project – asserts its commitment to strengthening national regulatory systems in Africa and supporting to implement good regulatory practices for regulatory oversight of vaccines and biologics. The training conducted in the remit of the Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) project, served to complete the PEI’s work package with a specific objective to enhancing the regulatory skills and knowledge of FDA Ghana Clinical Trials regulators involved in evaluating Clinical Trials Applications and monitoring risk-benefit balance of new vaccines and biologics candidates. The RCORE Trainers from Ghana with the VaccTrain team at PEI in Langen (Source: PEI/VaccTrain) BERC-Africa is an EDCTP2-funded project coordinated by FDA Ghana and supported by local and international partners including the PEI in a concerted effort aimed at bolstering the capacity of African regulators in the area of Clinical Trials. As part of its work package under a consortium agreement, the PEI on 30th September 2022 completed the training of two selected regulatory staff from the Clinical Trials department of FDA Ghana in a ‘Train-the-Trainer’-model regulatory attachment in Germany. The trainees were regulators who are involved in CTO activities and play leading roles as trainers in FDA Ghana’s Regional Center of Regulatory Excellence (RCORE) clinical trials fellowship training programme. Due to the pandemic, the training which was originally scheduled to be a 45-day on-site training at the PEI, was delivered in two parts: a two-week online theoretical part (June 20-July 1, 2022) and a four-week practical, hands-on session on-site at the PEI in Langen, Germany (September 5-30, 2022). The GHPP PEI-VaccTrain team and experts from other PEI departments shared their knowledge in virtual lectures and on-site in Langen during the hands-on assessments. In addition to the two regulators, around 23 regulators from the FDA Ghana and other VaccTrain partner regulatory authorities including The Gambia, Liberia, Sierra Leone and Zimbabwe took part in the first virtual theoretical part. Overview of training content: The VaccTrain team, led by Dr. Heidi Meyer, Head of the International Coordination and Regulatory Service Unit at the PEI, and experienced assessors and biostatisticians from the Paul-Ehrlich-Institut provided training on the following thematic areas in lectures and practical applications: Organizational structure and legal regulatory framework in Germany and the European Union (EU) for regulatory monitoring of clinical trials, as well as insight into the structures of work-sharing within the EU. Regulatory assessment and technical know-how regarding quality, non-clinical and clinical evaluations as well as statistical assessment of clinical trial applications Monitoring the risk-benefit balance of vaccines and biologics during the conduct of clinical trials Regulatory scientific advice formats at PEI and the EU that facilitate the translation of research results into medicinal products and support product development at various stages Suggestions on how to improve own skills in knowledge transfer and mentoring other African regulators Exchange on current challenges in clinical trial evaluation. Training Sessions, on the left with Dr. Heidi Meyer, Head of the International Coordination and Regulatory Service Unit at PEI, on the right with the Innovation Office (Source: PEI/VaccTrain) Feedback on the training: What the fellows rated as particularly relevant In a post-training evaluation, the two RCORE trainers cited the Scientific Advice procedures they experienced at PEI as a highlight. They found the structure of the Advice to be well defined, robust and insightful, with concrete questions from the manufacturers and, accordingly, dexterous and proficient expertise from PEI in addressing them. Equally instructive was the practical assessment of real clinical trial applications. The PEI assessors tailored their instructions to FDA Ghana vaccine clinical trials application landscape context and the related critical and safety-relevant aspects. The trained fellows rated the exchange of information on more complex, novel agents as valuable. The same applies to the complex world of biostatistics. Here, the fellows were pleased with the insight into analysis and the applicable statistical tools that provide support in a more mechanized manner. Back at their home agency, the FDA Ghana, the two fellows are expected to pass on their knowledge through internal seminars to other colleagues, with practical exercises on real trial applications. The concept also envisages that the PEI fellows incorporate their newly acquired skills into the curriculum of the RCORE training courses and pass them on to future RCORE training participants. These measures shall ensure sustainable multiplication at the regional level. Richard & Yvonne from FDA Ghana with Olga & Ulysse from VaccTrain discussing the Training Expectations at the beginning (Source: PEI / VaccTrain) PEI work package in the BERC project PEI is a partner in the European Union-funded BERC-Africa project, for which the Ghana Regulatory Authority - FDA Ghana – is the co-ordinating institution. The project aims to strengthen regulatory capacity in Africa in the area of clinical trials oversight to ensure that clinical trials in Africa meet appropriate and modern regulatory standards. Through its New Partnership for African Development (NEPAD)-designated RCORE CT fellowship training program, FDA Ghana has since 2017, played an important role in training regulators from many African countries in regulatory science applicable to clinical trials oversight. Through this BERC-Africa project, the FDA Ghana aims to continually enhance the delivery and quality of the RCORE deliverables through the Train-the-Trainer scheme. In this model, the PEI's work package serves to address the strengthening of the clinical trials RCORE training in Ghana. The six weeks "high-level" training and consulting program for two trainers from the Ghana RCORE for Clinical Trials was specifically designed to build their regulatory skills and knowledge, particularly in the area of evaluating clinical trial applications and monitoring the benefit-risk balance of vaccines and biologics. The virtual training part with lectures from PEI experts were also accessible to regulators from all VaccTrain partner countries (Source: PEI / VaccTrain) GHPP VaccTrain Project at PEI is Committed to Establishing Efficient Regulatory Oversight of Clinical Trials As part of the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health, PEI's VaccTrain project has been working with five African partner countries since 2017 to build regulatory structures and competencies for the regulatory oversight of clinical trials in the partner countries. The Ebola crisis in particular showed that there is a massive need to catch up in this area and revealed how relevant an efficient regulatory authority that can ensure rapid and appropriate regulatory assessment of clinical trial applications is for combating health crises. Excursus: Why it is important to monitor clinical trials by regulatory authorities The official monitoring of clinical trials by national regulatory authorities serves to ensure the safety and observance of the rights of trial participants, patients and the general public. Before new vaccines or drugs can be administered to humans for the first time, manufacturers must demonstrate their safety and efficacy in clinical trials. In most countries, an application to conduct a clinical trial must be submitted to the responsible regulatory authority. This authority examines the applicant's documents, approves the clinical trial (Phase I-II), can demand improvements or reject the trial with justification. The conduct of the trial itself is also monitored by the authorities and checked through routine or triggered inspections. Ideally, regulatory monitoring is anchored in law and led by regulations and guidelines. These form the justifying basis and guide for regulatory decisions. SOURCE: https://ghpp.de/en/projects/regtrain-vacctrain/clinical-trials-rcore-trainers-from-fda-ghana-completed-a-six-week-training-held-by-the-paul-ehrlich-instituts-ghpp-vacctrain/

As part of the goal of EDCTP Work Package 4 under the BERC Africa project, the FDA Ghana nominated two officers from its Clinical Trials Department to embark on a extensive professional internship program at Paul-Elhrlich Institut, an Agency of the German Federal Ministry of Health. The training was intended to build capacity and provide field experience in clinical trial applications, monitoring and evaluation of risk benefit balance of vaccines and biologics. The 45-days training provided experiential learning in the conduct of Scientific Advice Meeting, Evaluation of Clinical Applications, Clinical and Non-Clinical Assessment, Quality and Statistical Assessment At the end of the training the Ghanaian delegation expressed their profound gratitude to Paul-Elhrlich Institut and applauded the organizers of the training for the depth of knowledge imparted as well as the networking opportunities created. They noted that the training has further enhanced their knowledge and would enable them to continue to deliver similar capacity building program in Ghana as a Regional Center for Regulatory Excellence in clinical trial in Africa. From left to right (Dr. Ulysse Ateboa, Dr. Heidi Meiyer, Dr. Yvonne Adu-Boahen, Mr. Richard Osei Buabeng, Dr. Olga Rassokhina)

The Food and Drugs Authority (FDA) Ghana, in collaboration with the School of Public Health (SPH), Legon, organized the 5th Clinical trials fellowship training in August 2022. This follows four successful trainings organized in November 2017, August 2018, August 2019 and August 2020 by the FDA as a designated Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials Regulation in Africa. The training forms part of the capacity-building activities under the Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) Project which is being funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). The training was originally intended for ten (10) participants, however, a total of fifteen (15) African regulators were trained as there was additional sponsorship from the Paul Ehrlich Institute (PEI), Germany. For the first time since its inception, the training had Six (6) Francophone participants. The RCORE training aims at building capacity in clinical trials (CT) within the sub-region to enhance the conduct of clinical trials and improve access to medicine by harmonizing regulatory requirements. This is to ensure that African citizens have access to quality, safe and efficacious medication, medical devices, and health-claimed products. The 4-week intensive programme which commenced on 1st August 2022 and ended on 26th August 2022, was attended by fifteen (15) participants from the African sub-region (Cameroon, Kenya, Rwanda, Nigeria, Guinea Conakry, Gambia, Gabon, Benin, Liberia, Senegal and Ghana).Topics covered included: Evaluation of Clinical Trial Application (Clinical, Non-clinical, Quality and Statistics) Drug Development Ethics and Historical Perspective on Drug Development Regulation • Assessment of Statistical Analysis Protocol Development Institutional/Independent Ethics Committee Development of Clinical Trials Application GCP Inspection (theory and practical) Trial Management and Implementation Quality Assurance • Reporting from trial sites Post Marketing Approval Pharmacovigilance and Signal detection. There was practical regulatory attachment where participants got hands-on experience of the theoretical aspect of the training in the areas of Clinical Trials Authorization (including both preliminary and detailed evaluation of CT Applications) and Good Clinical Practice (GCP) Inspections. Sessions began each day at 9:00 am with a recap of the previous day and ended by 5:00 pm. There were PowerPoint presentations, discussions and exercises each day with a tea/coffee break and a lunch break in between. Participants also had the opportunity to observe a GCP inspection of two ongoing clinical trials in the Ashanti Region of Ghana, the 75th Technical Advisory Committee Meeting on Clinical Trials as well as the FDA’s Annual GCP training held virtually in Accra. The participants appreciated the RCORE training well, and generally, the training objectives and expected learning outcomes were achieved. Participants were keen on using the knowledge and skills acquired in their respective fields of work and improving clinical trial regulation in their home countries and in the sub-region. The major challenge faced during the training was the language barrier for the francophone participants. A translator had to translate every lecture which prolonged the entire lecture hours. This resulted in some lecturers not being able to complete their lectures within the stipulated time. Additionally, the translation devices used for the training did not function as expected. For subsequent training it is therefore being recommended that: A professional translator who is equally knowledgeable in Clinical Trials regulation should be included as part of the facilitators when inviting francophone participants. Alternatively, as part of the criteria for selecting participants from francophone countries, participants should be either bilingual or required to have at least a limited working proficiency in the English Language. The statistics session and its content should be extended to about 2 or 3 days. Expand the RCORE faculty to include facilitators from other African countries and the rest of the world to share their experiences in clinical trials across the world to enrich the course. Participants’ comments and impression about the training

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.

The COVID-19 pandemic took the world by storm and the only way to navigate its associated challenges was to find innovative ways of doing things. Virtual meetings supplanted traditional face-to-face meetings and paved the way for ever-increasing participation, since transportation and logistical obstacles were no longer impediments. The EDCTP work package 4 which involves a 45-day regulatory attachment of two (2) RCORE trainers at Paul-Ehrlich-Institut (PEI) has this time around decided to take advantage of the virtual space to allow for the participation of more trainers/regulators. PEI (work package lead) with support from FDA Ghana has divided the package into two: 2 weeks virtual training in the form of lectures and seminars 30 days of hands-on activities at the different departments of PEI for two (2) regulators The main objectives of this package are: To enhance regulatory skills and knowledge in the area of Clinical Trial Applications assessment and monitoring benefit-risk balance of vaccines and biologics. To provide mentorship and continuing professional development for regulators involved in the evaluation of Clinical Trial Applications. The first part of the package which is the two (2) weeks virtual training begins on Monday, June 20, 2022 and ends on Friday, July 1, 2022. This training involves RCORE trainers as well as regulators from Ghana, Sierra Leonne, The Gambia, and Liberia. The activities lined up for the 2 weeks are in the attached document:

In May 2014, Ghana's Food and Drugs Authority (FDA) was designated by the New Partnership for African Development (NEPAD) and the African Regulatory Harmonization (AMRH) as a Regional Centre of Regulatory Excellence (RCORE) in Clinical Trials and Drug Registration. This designation was assigned to FDA Ghana in recognition of the institution’s proven capacity and capability in training and delivering as a regulator of clinical trials. As an RCORE, the FDA seeks to build regulatory capacity in Africa to facilitate quality review of clinical trials and harmonize existing clinical trial processes in the sub region in line with globally accepted standards. This is to ensure that African citizens have access to quality, safe and efficacious medication, medical devices and health products. Following the FDA’s designation as an RCORE, the Clinical Trials Training Manual for Capacity Building in Regional Centres of Regulatory Excellence (RCOREs) and other training institutions was developed in 2016 by the FDA in collaboration with the University of Ghana School of Public Health. This manual can be found on the website of NEPAD. Since 2017, FDA Ghana has been organizing an annual RCORE clinical trials fellowship that has trained a total of fifty-four (54) clinical trials regulatory experts from ten (10) African countries. The RCORE Fellowship training is an intensive 4 week learning journey with theoretical and practical training modules. The specific objectives are the training are as follows: Increasing regulatory workforce to facilitate review of clinical trials conducted in Africa. Harmonising and improving existing clinical trial processes in Africa in line with globally accepted standards (WHO an ICH guidelines) while taking into consideration local conditions peculiar to each African country. Providing a platform for regulators and researchers to continually share ideas, knowledge and experiences over the years. Helping African regulators to enhance and effectively apply the existing regulatory tools in the regulator’s toolkit. Building capacity and enhancing skills of regulators in the area of effective clinical trial regulation through hands-on training and exchange programmes to help improve their output. So far, the RCORE training has been well appreciated by the participants with training objectives and expected learning outcomes being achieved. Participants have reported increased knowledge of drug development processes and the impact of research on the safety, quality and efficacy of medicines. Trainees were keen on using the knowledge and skills acquired in their respective fields of work and improving clinical trial regulation in their home countries and the sub-region. It can therefore be deduced that the training was effective in accomplishing its core goal of building the capacity of the participants to strengthen and harmonize the clinical trial regulatory systems in Africa. The RCORE training therefore has the potential to enhance the conduct of clinical trials in Africa, thus the training of RCORE trainers as part of the BERC-Africa project would serve as a significant step towards the achievement of this aim. The BERC-Africa project also offers the opportunity for the FDA Ghana to extend the scope of this RCORE training to serve Francophone countries for the first time. Under this funding, provision has been made to enable the translation and delivery of the RCORE training and training material in French.