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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

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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.

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