CLINICAL TRIALS FELLOWSHIP TRAINING
The Food and Drugs Authority (FDA) Ghana is organizing its maiden Regional Center of Regulatory Excellence (RCORE) Fellowship training workshop on Clinical Trials from 6th – 30th November 2017 in Accra, Ghana.
The RCORE fellowship training workshop is a collaboration between the Food and Drugs Authority, Ghana and the School of Public Health, University Ghana and 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 safe, efficacious and quality medication.
The objective of the workshop is 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. This workshop is 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.
Participants of the workshop, ten (10) in numbers, are from 5 African countries namely Ghana, Zambia, Liberia, Rwanda and Sierra Leone within the Medicine Regulatory Agencies and Health Institution.
It is expected that on return to their respective countries, participants will impart to others the knowledge they have acquired, to enhance the evaluation of Clinical Trial document such as the Protocol Investigators Brochure and the Informed Consent Form. The training also seeks to ensure that participants will demonstrate an understanding of the roles and responsibilities of different individuals and stakeholders in clinical research.
The 4-week intensive training workshop will cover Clinical Trials Authorization, Good Clinical Practice (GCP) inspection, Adverse Events and Safety Monitoring (Pharmacovigilance).
There will also be practical attachment where the participants will have hands on experience of the theories at the end of the workshop.