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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.

RCORE CLINICAL TRIAL REGULATORY FELLOWSHIP PROGRAMME Button OBJECTIVES OF PROGRAM Build capacity and enhance skills of regulators in the area of effective clinical trial regulation through hands-on training and exchange programs to help improve their output. Increase regulatory workforce to facilitate quality review of clinical trials conducted in Africa. Provide a platform for regulators and researchers to continually share ideas, knowledge and experiences over the years in the aim of improving their activities Build capacity and enhance skills of researchers in the area of conduct of clinical trials through hands-on training to help improve their output 30-DAY INTENSIVE FELLOWSHIP COURSE COURSE CONTENT 'To achieve the above objectives, the FDA has designed an intensive fellowship course covering the following areas; I. Clinical Trials Authorization Clinical Trials in Practice This module investigates the key steps in the logistical and implementation of clinical trials. It clarifies and operationalizes the primary and secondary objectives of clinical trials and implications of design choices for implementation of a trial. The module will also examine the governance , data collection and recruitment methods. Quality assurance and control, data processing and management issues will be explored as well. Regulatory Issues, Good Clinical & Laboratory Practice The module seeks to develop participants understanding of the main features relating to regulatory legislation and associated approvals and permissions required to conduct high quality clinical trials. Key issues relating to the legislation of Good Clinical Practice (GCP), understanding GCP, implementing GCP, including risk assessment and trial monitoring will be discussed. Good Laboratory Practice (GLP) in trial settings, Quality control and assurance systems shall also be explored. The focus will be on trials of drug products but trials in variety of other areas and in different locations will be taught. Ethics of Clinical Research in developing countries The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki Protocol Development The aim of this module is to be able to learn to develop the trial protocol and the steps to be taken for preparing the protocol for a trial: This entails how to develop the data collection forms, understand the required logistical and budgetary issues in the preparation of the protocol, and procedures different funding bodies use to award grants. I. Clinical Trials Authorization Clinical Trials in Practice This module investigates the key steps in the logistical and implementation of clinical trials. It clarifies and operationalizes the primary and secondary objectives of clinical trials and implications of design choices for implementation of a trial. The module will also examine the governance , data collection and recruitment methods. Quality assurance and control, data processing and management issues will be explored as well. Regulatory Issues, Good Clinical & Laboratory Practice The module seeks to develop participants understanding of the main features relating to regulatory legislation and associated approvals and permissions required to conduct high quality clinical trials. Key issues relating to the legislation of Good Clinical Practice (GCP), understanding GCP, implementing GCP, including risk assessment and trial monitoring will be discussed. Good Laboratory Practice (GLP) in trial settings, Quality control and assurance systems shall also be explored. The focus will be on trials of drug products but trials in variety of other areas and in different locations will be taught. Ethics of Clinical Research in developing countries The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki I. Clinical Trials Authorization I. Clinical Trials Authorization Ethics of Clinical Research in developing countries The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki Protocol Development The aim of this module is to be able to learn to develop the trial protocol and the steps to be taken for preparing the protocol for a trial: This entails how to develop the data collection forms, understand the required logistical and budgetary issues in the preparation of the protocol, and procedures different funding bodies use to award grants. I. Clinical Trials Authorization Clinical Trials in Practice This module investigates the key steps in the logistical and implementation of clinical trials. It clarifies and operationalizes the primary and secondary objectives of clinical trials and implications of design choices for implementation of a trial. The module will also examine the governance , data collection and recruitment methods. Quality assurance and control, data processing and management issues will be explored as well. Regulatory Issues, Good Clinical & Laboratory Practice The module seeks to develop participants understanding of the main features relating to regulatory legislation and associated approvals and permissions required to conduct high quality clinical trials. Key issues relating to the legislation of Good Clinical Practice (GCP), understanding GCP, implementing GCP, including risk assessment and trial monitoring will be discussed. Good Laboratory Practice (GLP) in trial settings, Quality control and assurance systems shall also be explored. The focus will be on trials of drug products but trials in variety of other areas and in different locations will be taught. Ethics of Clinical Research in developing countries The course aims to discuss the critical ethical issues related to conducting clinical trials in the developing world. The course will cover a historical overview of research ethics in the developing world, medical and human ethics, risk-benefit assessments, vulnerable populations as research subjects, informed consent process and documentation, privacy and confidentiality of research subjects and data, responsible conduct of scientific research, the role and functions of Institutional Review Boards, Data and Safety Monitoring Boards, international research and the Declaration of Helsinki Protocol Development The aim of this module is to be able to learn to develop the trial protocol and the steps to be taken for preparing the protocol for a trial: This entails how to develop the data collection forms, understand the required logistical and budgetary issues in the preparation of the protocol, and procedures different funding bodies use to award grants.

BERC-AFRICA WORK PACKAGES 01 PROJECT MANAGEMENT AND COORDINATION. This encompasses all activities geared towards coordination of technical, financial and administrative issues of the project. This Work Package is to be led by the Food and Drugs Authority (FDA) and expected to span from Year 1 to 3. The objectives of this package are to: ​ Coordinate activities to develop a project management strategy Ensure the implementation and integration of all work packages Ensure proper coordination of all partners and collaborators Coordinate all SC meetings, including Kick-off and Closure meetings Effectively monitor timelines set for deliverables and milestones and objectives of the entire project 02 RCORE FELLOWSHIP TRAINING IN CLINICAL TRIALS. This is a 4-week intensive theoretical and practical training for 10 African regulators. This session would be modeled after the FDA’s well acclaimed RCORE trainings and would include for the first time, regulators from francophone countries. The work package is to be led by the FDA with support from the University of Ghana School of Public Health (UG SPH) in year 2 of the project. The main objectives of this package are: ​ The participants will have hands-on experience on evaluation of Clinical Trial Applications and GCP inspections by using AVAREF templates, RCORE Training manual. Observe how the FDA engages external experts on issues related to clinical trials during Technical Advisory Committee meetings The establishment of a platform for regulators to share ideas, knowledge and experiences over the years. 03 TRAINING AND MOBILITY ACTIONS FOR REGULATORY OFFICERS IN AFRICA. This package includes three (3) short courses for regulators (trainers) involved in RCORE training as well as those responsible for assessment of clinical trial application related documents in Ghana and some African countries: This work package is to be led by Coalition for Epidemic Preparedness Innovation (CEPI) with support from FDA Ghana. ​ The trainings to be completed are: ​ Introductory course in Epidemiology and Medical Statistics for 1 regulator Pre-Clinical and First in Human Studies (FIH) and Complex/Adaptive study designs training for 8 - 10 regulators Essentials of clinical trials or Systematic Reviews and Meta-Analysis for 2 regulators The main objectives are to: ​ Build capacity to enhance output in regulation of clinical trials in Africa especially FIH, complex and adaptive studies Provide mentorship and training for RCORE trainers and those responsible for CT Application evaluation in Ghana 04 REGULATORY ATTACHMENT AT PAUL EHRLICH INSTITUT. This package involves a 45-day regulatory attachment of two (2) regulators at PEI. The attachment will be in the form of internal seminars, lectures, hands-on activities at the different departments in the host institution. This work package is to be led by Paul Ehrlich Institut (PEI) with support from FDA Ghana. ​ The main objectives of this package are: ​ Enhance regulatory skills and knowledge in the area of Clinical Trial Applications assessment and monitoring benefit-risk balance of vaccines and biologics. Provide mentorship and continuing professional development for regulators involved in the evaluation of Clinical Trial Applications.

Welcome to BERC AFRICA Building and enhancing Regulatory Capacity in Africa FDA GHANA RCORE TRAINING Below are some lovely images from the FDA's 5th RCORE and Advanced RCORE training organized in the year 2022. Click on the link below to read more. Read More RECENT POSTS 49 minutes ago 1 min RCORE GHANA FDA CONDUCTS ADVANCED RCORE TRAINING FELLOWSHIP 2022 The Ghana Food and Drugs Authority (FDA) in collaboration with the School of Public Health of the University of Ghana and support from... 28 views 0 comments Post not marked as liked Dec 6 5 min RCORE Clinical Trials RCORE trainers from FDA Ghana completed a six-week training held by the Paul-Ehrlich With this training, the Paul-Ehrlich-Institut (PEI) – through the GHPP VaccTrain project – asserts its commitment to strengthening... 16 views 0 comments 3 likes. Post not marked as liked 3 Oct 14 1 min RCORE GHANA FDA PAYS A WORKING VISIT TO PAUL-EHRLICH-INSTITUT 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... 14 views 0 comments 2 likes. Post not marked as liked 2 Benin Learning in a good mood”... These are my words if someone asks me to describe RCORE learning. Thank you to all the FDA team for sharing transparently your experience and allowing other African countries to improve our skills. Learning from the BEST! -Mrs. Rhanda Adechina Adehan The Gambia Here are some interesting comment the participants had to say about the RCORE fellowship training. Senegal Thank you for your enriching and construction at the beginning of my professional career on trials. This training allowed me to consolidate my knowledge in clinical trials. This training will also be useful for setting up on clinical trials department. ARP Senegal thanks you. -Prof. Yoro Tine Cameroon Thank you for this beautiful moment spent together for this opportunity which goes beyond the professional but also the love for a continent. You are a model to the new Africa. -Nana Clarisse Meme Rwanda Ghana RCORE is a great career credential. The range of teaching methodologies reflects the complexity of clinical trials. The use of a combination of intensive classroom training and the hands-on-skill building was very effective. -Pharm. Nora Obodai Kenya RCORE FELLOWSHIP TRAINING IN CLINICAL TRIALS OVERSIGHT I want to thank the FDA for organizing such valuable capacity-building training as this will significantly add value to my professional career. I hope and pray that the RCORE training will continue to grow from strength to strength to support the region in human resource development. -Dr. Alhagie Mutarr Bah Being in this beautiful land of Ghana has been a great experience. The RCORE program has enlightened me in the area of clinical trial inspection and Technical Advisory Committee meetings. I have appreciated the interactions, enjoyed the multinational diversity and the love extended to me. I leave as a better regulator, looking forward to implementing the lessons learnt to improve clinical trial regulation in Kenya. I highly appreciate my agency (Pharmacy and Poisons Board, Kenya) for the nomination to attend this session. I recommend this RCORE to all regulators. Mr. Samuel Kerama To Ghana FDA, it is a great opportunity for having participated in the 5th RCORE. It is an honour to witness the implementation and collaboration between Rwanda FDA and Ghana FDA for working towards harmonization of regulatory functions and mutual support in every way to ensure the safety of people. -Dr. Ndayambaje Alphonse OVERVIEW OF THE PROJECT Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) is part of the EDCTP2 Programme supported by the European Union. It seeks to bolster the capacity of African regulators in the area of clinical trials, with the FDA as the lead implementer and 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). RCORE CLINICAL TRIAL REGULATORY FELLOWSHIP PROGRAMME Are you a National Regulatory Authority (NRA) interested in applying for our RCORE Clinical Trail Fellowship Programme? ​ If YES, ​ Click the button to download our brochure for more information and kindly fill the form to apply. Brochure Form Quote Equipping regulators with enhanced regulatory skills and knowledge in quality assessment and compliance monitoring of clinical trials applications / BERC AFRICA