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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)

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

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About BERC-AFRICA Learn about BERC-AFRICA, its objectives and more Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) The rapid geographic spread of infectious diseases is a major public health concern that can be arrested by increasing the pace and efficiency of related clinical trials. In recognition of this need Food and Drugs Authority (FDA) Ghana sought to bolster the capacity of African regulators in the area of clinical trials. ​ In April 2020 the FDA received favorable response to its application to the European and Developing Countries Clinical Trials Partnership (EDCPT) for clinical trial capacity building. ​ The project, Building and Enhancing Regulatory Capacity in Africa (BERC-Africa) was officially commenced on 1st October 2020 with FDA Ghana as the lead implementer with 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). ​ OUR OBJECTIVES i ​ Train regulators from National Medicines Regulatory Agencies (NMRAs) under the Regional Centre of Regulatory Excellence (RCORE) Fellowship Training in Clinical Trials, including those from Francophone countries. ii Train regulators from National Medicines Regulatory Agencies (NMRAs) under the Regional Centre of Regulatory Excellence (RCORE) Fellowship Training in Clinical Trials, including those from Francophone countries. iii Train regulators from National Medicines Regulatory Agencies (NMRAs) under the Regional Centre of Regulatory Excellence (RCORE) Fellowship Training in Clinical Trials, including those from Francophone countries. SPONSORING PARTNER The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public-public partnership between countries in Europe and sub-Saharan Africa, supported by the European Union. COLLABORATING PARTNERS Food and Drugs Authority Provide technical coordination as well as financial and administrative management to accomplish the objectives of the project. University of Ghana School of Public Health (UG SPH) Provide resource persons for the theoretical session of the RCORE Fellowship Training Programme in Clinical Trials. Kumasi Centre for Collaborative Research (KCCR) into Tropical Medicine, KNUST Provided a potential site for GCP inspection during the RCORE Fellowship Training . Paul-Ehrlich-Institute S erve as the host institute for regulatory attachment for RCORE trainers. Coalition for Epidemic Preparedness Innovation Provide a resource person for regulatory training in first-in-human and early phases of vaccine clinical trials, complex and adaptive designs in clinical trials. EXPECTED IMPACT Following the implementation of the project, regulators will have enhanced regulatory skills and knowledge in quality assessment and compliance monitoring of clinical trails applications. ​ In the long run this would ensure the credibility of results or data collected in the conduct of clinical trials in Africa, leading to informed decision making for public health related issues and improvement in human health.