FDA ENDS CLINICAL TRIALS FELLOWSHIP WORKSHOP – A BIG STEP IN REGULATION OF CLINICAL TRIALS IN SUB-SAHARAN AFRICAN
The Food and Drugs Authority (FDA) in collaboration with the School of Public Health of the University of Ghana partnered by New Partnership for African Development (NEPAD) and African Regulatory Harmonization (AMRH) have organized its maiden Regional Center of Regulatory Excellence (RCORE) Fellowship training workshop on Clinical Trials which commenced from 6th – 30th November 2017 in Accra, Ghana.
The RCORE fellowship training which will be organized annually for the next five years, was funded by International Aids Vaccine Initiative, INC (IAVI) sought to build capacity in clinical trials within the sub-region and further enhance access to medicine by harmonizing regulatory requirements. This will ensure that African citizens have access to quality, safe and efficacious medication.
In collaboration with the Technical Advisory Committee on Clinical Trials (TAC) the training was opened on Monday 6th November 2017 with the objective of training participants to increase the regulatory workforce on the African continent by nurturing and developing technical competency to ensure effective clinical trials regulations in Africa. This workshop was also to provide a great platform for regulators, researchers and stakeholders to meet and continually share ideas, knowledge and experience over the years with the aim of learning from one another and improving activities.
Mrs. Delese A. A. Darko, the Chief Executive Officer (CEO) of FDA in her closing remarks extended her gratitude to all the role players; New Partnership for African Development (NEPAD), African Regulatory Harmonization (AMRH), the School of Public Health of the University of Ghana, the clinical trials department of FDA, training facilitators and coordinators that put in great effort to make this programme a success.
She indicated her optimism in seeing a positive change with regards to the conduct of Clinical Trials not only in their various countries but across the African Continent.
The Dean of the School of Public Health, Prof. Richard Adanu, on his part, advised the participants to ensure that they put into practice whatever knowledge have been acquired through the training and ensure to impact the knowledge to others in their respective countries.
The participants from Sierra Leone, Liberia, Rwanda, the Gambia and Ghana thanked the FDA and the School of Public Health for the training offered and regulatory tools shared with them. They indicated that the training was very informative and would help them enhance their regulatory activities on clinical trials, hence clinical trials in the sub-region would be similarly regulated.
The 4-week intensive program covered topics on Clinical Trials Authorization, Good Clinical Practice (GCP) inspections, Adverse Events and Safety Monitoring (Pharmacovigilance) and a practical regulatory attachment where trainees got hands – on experience of the theoretical aspect of the training. Trainees also had the opportunity to observe a GCP inspection in the Ashanti Region of Ghana.