FDA Holds Clinical Trials Workshop

The Food and Drugs Authority (FDA) Ghana has organized its maiden Regional Center of Regulatory Excellence (RCORE) Fellowship training workshop on Clinical Trials which commenced from November 6 to November 30 2017 in Accra.

A statement issued by the FDA and copied to the Ghana News Agency said the RCORE fellowship training was a collaboration between the FDA, Ghana and the School of Public Health, University of Ghana partnered by New Partnership for African Development, (NEPAD) and African Regulatory Harmonization (AMRH), which seek to build capacity in clinical trials within the sub-region and further enhance access to medicine by harmonizing regulatory requirements.

The statement said this will ensure that African citizens have access to quality, safe and efficacious medication.

The statement said the objective of the training was to increase the regulatory workforce on the African continent by nurturing and developing technical and managerial competences to ensure effective clinical trials regulations in Africa.

It said the workshop was also to provide a 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 of FDA, extended her gratitude to all the role players; New Partnership for African Development (NEPAD), African Regulatory Harmonization (AMRH), the School of Public Health, University of Ghana, the training facilitators and coordinators that put in great effort to make this programme a success.

She expressed optimism in seeing a positive change with regards to the conduct of clinical trials not only in their various countries but across the whole African Continent.

Professor Richard Adanu, the Dean of the School of Public Health, on his part, advised the participants to ensure that they put into practice whatever knowledge have been acquired through the training in their respective countries.

He said the School of Public Health of the University of Ghana has introduced a new Master Program in Clinical Trials which would start during the next academic year.

The four-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 of the 'Malaria 094 Vaccine Trial' during a field trip to Agogo in the Ashanti Region of Ghana.

GNA