FDA Commence 5th Regional Centre of Regulatory Excellence (RCORE) Fellowship Training (PICS)
The Food and Drugs Authority (FDA) has commenced the 5th Regional Centre of Regulatory Excellence (RCORE) Fellowship Training in Accra for regulators, researchers and Clinical Trial stakeholders from some selected African countries.
According to the FDA, the 5th Regional Centre of Regulatory Excellence (RCORE) Fellowship Training will last for four (4) weeks.
In a speech read on behalf of the Chief Executive Officer (CEO) of the FDA, Delese Darko, the Deputy Chief Executive (DCE), Health Products and Technology, Seth Seneake said “The Chairman of the Technical Advisory Committee; Clinical Trials, the Dean of School of Public Health, Resource Persons, and Training participants, may I take this opportunity to welcome you all to the 5th Regional Centre of Regulatory Excellence (RCORE) Fellowship Training Programme in Clinical Trials. We thank God we are able to meet in person for this year’s training after COVID-19 restrictions prevented this in 2020”
The statement also mentioned that the RCORE fellowship training, which is a collaboration between the Food and Drugs Authority Ghana and the School of Public Health, University of Ghana, seeks to build capacity in Clinical Trials in Africa and improve access to much needed pipeline therapeutic medicines by harmonizing clinical trial regulatory requirements.
This, according to the statement, is to ensure that African citizens have access to quality, safe and efficacious medication.
He said “This training provides a great platform for regulators, researchers and Clinical Trial stakeholders to meet and continually share ideas, knowledge and experiences over the years with the aim of learning from one another and improving activities”
This year’s training is being organized under the EDCTP funded project titled Building Regulatory Capacity in Africa (BERC-AFRICA) with additional sponsorship from the Paul Ehrlich Institute (PEI).
“It promises to be special as for the first time since its inception, we have Francophone participants in this training.”
The 4-week intensive programme will cover Clinical Trials Authorization, Good Clinical Practice (GCP) inspection, review of reports from trial sites and a practical session where trainees will have a hands-on experience of the theoretical aspect of the training by reviewing a clinical trial application using the AVAREF forms.
Participants were urged to fully participate in all activities.
Madam Darko extended her gratitude to the Africa Union New Partnership for African Development (AUDA-NEPAD), EDCTP, Paul-Ehrlich-Institut (PEI), the School of Public Health, the training facilitators and coordinators that have made it possible for this training to come off today.
On his part, Professor and Dean at the School of Public Health, College of Health Sciences, University of Ghana, Professor Kwasi Torpey said “As an RCORE, the FDA seeks to build regulatory capacity in Africa to facilitate quality review of clinical trials and harmonize existing clinical processes in the sub region in line with globally accepted standards.”
He added that this is to ensure that African citizens have access to quality, safe and efficacious medication, medical devices and health products.
He remined the participants that the RCORE Fellowship training is an intensive programme with theoretical and practical training modules.
“The specific objectives are to increase regulatory workforce to facilitate revie of clinical trials conducted in Africa and also harmonize and improve existing clinical trial processes in Africa in line with globally accepted standards (WHO and ICH guidelines) while taking into consideration local conditions peculiar to each African country”
Taking her turn, Head of Clinical Research Department, Centre for Plant Medicine Research, Mampong-Akuapem, Mavis Boakye-Yiadom said “The FDA since 2004 has given authorization for the conduct of many clinical trials.
She added that prior to this, clinical trials were conducted without regulatory approval as required by International best practices and Good Clinical Practice.
“When the FDA started regulating the conduct of clinical trials in Ghana, many applications were deferred after initial evaluation due to incomplete documentation and the lack of awareness of the regulatory requirements by sponsors and investigators”
She added that there has been a tremendous improvement over the years with regards to general regulatory compliance due to the inputs and advice from the Technical Advisory Committee.
The participants who spoke to Thinknewsonline.com promised to partake fully in the four weeks programme.
They also added that they will use their stay to tour some interesting sites in the country.
Below are some pictures:
Story by: Joshua Kwabena Smith