FDA schools regulatory officers
Accra, July 7, GNA – To keep its regulatory officers abreast of current trends to enhance Food Drugs Authority (FDA) regulatory oversight the FDA, on Monday organised a training workshop for its regulatory officers.
The workshop facilitated compliance to Good Clinical Practice (GCP) and other regulatory requirements and build capacity for Ghanaian regulators.
It was organised by United Nations Inter-regional Crime and Justice Research Institute (UNICRI) and Agenzia Italiana del Farmaco (AIFA) in collaboration with FDA
The FDA as mandated by law has since 2004 regulated the conduct of clinical trials in Ghana through authorisation of trials and conduct of good clinical trial practice inspections.
FDA Chief Executive, Mr Hudu Mogtari, said the FDA has therefore put in the appropriate measures to develop a robust regulatory framework including reviewing its legal provisions for clinical trials.
It will also strengthen its human resource base by upgrading the clinical trials unit to a department and building staff capacity.
In this light, the FDA has received tremendous support in the form of training from the Government, World Health Organisation and also participated in several EU GCP inspectors workshops organised by the European Medicines Agency.
In May the FDA was designated as a Regional Centre of regulatory Excellency for clinical trials oversight and this implies that the Authority now has a bigger task of improving its capacity in clinical trials in order to live up to its growing responsibilities.
He said much effort had been put into the successful organisation of the training through selfless efforts of all especially UNICRI and AIFA and the FDA team.
Ms Aessandra Liuori O’neil of the UNICRI, said research showed that the main challenges that governments face are connected to lack of specific training, lack of organisational funding and lack of independence in the evaluation of clinical trials.
UNICRI was established in 1967 to support countries worldwide in addressing crime and in administration of the criminal justice.
It has been structuring its work programmes and modus operandi to make them always responsive to the needs of international community and assists inter-governmental, governmental and non-governmental organisations in formulating and implementing improved polices in the field of crime prevention and criminal justice.
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