NOTICE OF VACANCY
The Food and Drugs Authority invites applications from the following experts to join the Technical Advisory Committee on Clinical Trials listed below:
1.Regularly review and advice the Authority on the clinical trials system in Ghana and make recommendations regarding its maintenance and improvement.
2.Perform causality assessment of Adverse Event (AE) reports relating to clinical trials presented to the TAC by the Authority.
3.Upon request Authority, the TAC will make recommendations to the Authority regarding actions the Authority may take to resolve issues or concerns related to the conduct of clinical trials. The TAC will also recommend to the governing Authority, based on information made available to it by the by the Authority on the need halt or suspend a clinical trial.
4.The TAC may also recommend publication of case reports, their risk/benefit evaluations, recommendations and communications arising from the TAC meetings that are deemed appropriate for medical and scientific journals with prior consent of the sponsor.
5.The TAC may recommend educational programs and topics for investigators aimed at enhancing reporting of AEs and improving compliance to Good Clinical Practice (GCP) as recommended by the ICH (International Conference on Harmonization) Guidelines and Helsinki Declaration.
6.Advice the Authority periodically on the Food and Drugs Authority guidelines for clinical trials and GCP.
7.Advice the Authority on clinical end points in the review of protocols submitted to the Authority.
8.Evaluation of final reports of clinical trials that have been approved by the Authority. Such evaluation will be based on the information provided to the TAC by the Authority. Evaluations should be relevant to the risk/benefit implications for the trial in question.
9.Advice the Authority on issues relating to GCP and Good Laboratory Practice (GLP) inspections conducted.
Mode of application
Interested applicants should submit their updated CVs (hard copy) to the Chief Executive Officer of the Food and Drugs Authority, (Location address: GPS CODE: GA-237-7316) by 31st December 2020.
The FDA exists to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances, tobacco and the conduct of clinical trials in the country.