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.