FDA ORGANISES 3RD RCORE CLINICAL TRIAL FELLOWSHIP TRAINING.
Mr. Seth Seaneke, the Acting Deputy Chief Executive Officer responsible for Drug Registration and Inspectorate Division, at the Food and Drugs Authority (FDA) has duly opened the 3rd Regional Centre of Regulatory Excellence (RCORE) clinical trial fellowship training. The RCORE fellowship program which is being organised from 6th August, 2019 to 30th August, 2019 in Accra, seeks to build capacity in Clinical Trials within the African Region and to improve access to medicine by harmonizing regulatory requirements.
Mr. Seaneke, who opened the program on behalf of the Chief Executive Officer of the FDA said, the 4-week intensive training is aimed at improving the conduct and regulation of Clinical Trials not only in the various countries of the participants, but across the whole African Continent. This he said will to a large extent ensure that African citizens have access to quality, safe and efficacious medication.
He added that the training also provides a great platform for regulators, researchers and Clinical Trial stakeholders to meet and continually share ideas, knowledge and experiences to enhance their activities.
A member of the FDA’s Technical Advisory Committee-Clinical Trials (TAC-CT), Prof. Alexander Nyarko, revealed that since 2004, the FDA has given authorization for the conduct of many Clinical Trials in Ghana. He however added that there have been many applications for Clinical Trials that have also been deferred after the FDA’s initial evaluation of submitted documents due to either incomplete documentation and the lack of awareness of the regulatory requirements by sponsors and investigators.
Prof. Nyarko further stated that prior to the FDA’s regulations, Clinical Trials were conducted without regulatory approval as required by international best practice and Good Clinical Practice. There has therefore been a tremendous improvement over the years with regards to general regulatory compliance with inputs and advice from the TAC-CT, Prof. Nyarko added.
Prof. Julius Fobil, the Acting Dean of the School of Public Health on his part, congratulated the FDA for organizing the training and reminded participants that there would be no safe medicine and inventions without clinical trials and thus the training could not have come at a better time such as this because Africa is looking for appropriate platforms for regulators and researcher across the continent.
This program which will cover Clinical Trials Authorization, Good Clinical Practice (GCP) inspections, Adverse Events and Safety Monitoring (Pharmacovigilance) and a practical regulatory attachment where trainees will have hands-on experience of the theoretical aspect of the training have participants drawn from, Ghana, Gambia, Liberia, Sierra Leone, Nigeria, Zimbabwe and Rwanda.
Other stakeholders for the training include the New Partnership for African Development (NEPAD), African Regulatory Harmonization (AMRH), Global Health Protection Programme (GHPP) VaccTrain at the Paul-Ehrlich-Institut (PEI), and the School of Public Health, University of Ghana.