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:

  1. A professional translator who is equally knowledgeable in Clinical Trials regulation should be included as part of the facilitators when inviting francophone participants.

  2. 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.

  3. The statistics session and its content should be extended to about 2 or 3 days.

  4. 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

​PARTICIPANT

​COUNTRY

​COMMENT

​Mrs. Rhanda Adechina Adehan

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!

Mr. Ngu Paul Nembo

Cameroon

It has been a wonderful experience being part of this fellowship program. Thank you, FDA Ghana, for improving my limited knowledge of the regulation of clinical trials. Thank you for your hospitality.

Mr. Leandre Orphe Nzame

Gabon

Please accept my modest thanks to the teachers. I enjoyed every minute of it, and I am infinitely grateful to you for the good times spent in your company. As we say at home “Akiba, Abora, Akewa. Thank you!

Dr. Ndayambaje Alphonse

Rwanda

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.

Prof. Yoro Tine

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.

Mr. Samuel Kerama

Kenya

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.

Dr. Alhagie Mutarr Bah

The Gambia

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. Carine Ngadi Mukagatare

Gabon

Congratulations to FDA. I am proud of your team. I was enjoying Ghana. I will come again.

Ms. Harriet Fianko

Ghana

I am highly grateful to my agency for giving me the opportunity to attend RCORE 2022. This training has enlightened and improved my scanty knowledge of clinical trial regulation. I hope to become a better regulator going forward. Thank you, FDA CT Team. Thank you, my fellow RCORE colleagues

Pharm. Nora Obodai

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

Dr. Aicha Drame

Guinea Conakry

​Thanks to the FDA and all the team for enriching my knowledge of clinical trials and for guiding me during these four weeks. Thank you for the care you have given to me. Ghana and Guinea-Conakry have been brothers since independence. Thank you for everything.

Pharm. Jennifer Essilfie -Conduah

Ghana

Meeting my colleagues from different African countries spiced up the program. Their knowledge and energy made this RCORE a unique one. The facilitators made justice to every topic given to them and the understanding of the participants was their main aim. Not forgetting about the lunch buffets every single day…. Wow! It was always a pleasure to be at lunch. The GCP inspection was one of a kind as we had so much fun alongside acquiring all the needed knowledge. RCORE 2022 has been successful, and I am glad I had the opportunity to be part.

Pharm. Sancee G. Gray

Liberia

Nobody is born with perfection. We all need some training and guidance to achieve perfection in any task. Training helps in achieving success in every field and clinical trials of no exception. I enjoyed the food, the trip to Kumasi and the visit to the museum. It was fun being together with all my colleagues from other countries. I will miss you all.

Ebele Perpetua Anto

Nigeria

I looked forward to this experience at the RCORE and must say I was not disappointed at all. The memory is indeed unforgettable and well cherished. Thank you, Ghana FDA for a great Job.

​Nana Clarisse Meme

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.




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