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- SUMMARY UPDATE ON THE 5TH CLINICAL TRIALS RCORE TRAINING- 2022
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
- FDA TO REVIEW ‘RCORE’ TRAINING MANUAL FOR CLINICAL TRIALS REGULATION WITH SUPPORT FROM GIZ
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.
- EDCTP SPONSORED BERC-AFRICA WORK PACKAGE 4: TRAINING FOR FDA GHANA RCORE TRAINERS
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:
- HOME | BERC-Africa
Welcome to BERC AFRICA Building and enhancing Regulatory Capacity in Africa FDA GHANA 5TH RCORE FELLOWSHIP TRAINING This training has successfully ended. On your right are some lovely images. Click the link below to read on the training summary. Read More RCORE FELLOWSHIP 2022 RCORE FELLOWSHIP 2022 RCORE FELLOWSHIP 2022 RCORE FELLOWSHIP 2022 1/31 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 RECENT POSTS 7 hours ago 3 min TECHNICAL REPORT SUMMARY UPDATE ON THE 5TH CLINICAL TRIALS RCORE TRAINING- 2022 The Food and Drugs Authority (FDA) Ghana, in collaboration with the School of Public Health (SPH), Legon, organized the 5th Clinical... 5 views 0 comments 1 like. Post not marked as liked 1 Jul 13 2 min RCORE FDA TO REVIEW ‘RCORE’ TRAINING MANUAL FOR CLINICAL TRIALS REGULATION WITH SUPPORT FROM GIZ The Food and Drugs Authority Ghana (FDA) with funding support from the German Development Cooperation Deutsche Gesellschaft für... 21 views 0 comments Post not marked as liked Jul 1 1 min RCORE EDCTP SPONSORED BERC-AFRICA WORK PACKAGE 4: TRAINING FOR FDA GHANA RCORE TRAINERS 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... 14 views 0 comments Post not marked as liked 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 Quote Equipping regulators with enhanced regulatory skills and knowledge in quality assessment and compliance monitoring of clinical trials applications / BERC AFRICA
- ABOUT | BERC-Africa
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.
- CONTACT | BERC-Africa
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