FDA trains pharmacists on Good Clinical Practice
Thursday, 19 November 2015
Posted by: Samuel Anim-Yeboah
Accra, Nov. 12 - The Food and Drugs Authority (FDA), has organised a two-day workshop on Good Clinical Practice (GCP) for Research Pharmacists to make them abreast of current trends in the industry.
The training course was designed to provide an introduction to GCP, local and international guidelines, regulations and other research governance framework requirements covering clinical trials and other clinical studies conducted in Ghana.
The rationale for the workshop, which has become an annual event of the FDA, was to ensure the credibility of clinical research, the protection of human subjects and the desirable roles of stakeholders on clinical trials.
About 30 participants across the country attended the workshop.
Mrs Delese Darko, Acting Deputy Chief Executive, Clinical Trials and Safety Monitoring Division, FDA, told the media that the training was necessary because regulation is dynamic, and there is therefore the need to bring Ghanaian research pharmacists abreast of new trends.
She said when research pharmacists are involved form the beginning of drug manufacturing, they become responsible for the safety and efficacy of the medicines.
The WHO Guidelines for GCP for trials on pharmaceutical products is to set globally applicable standards for the conduct of such biomedical research on human subjects.
They are based on provisions already promulgated in developed countries including Australia, Canada, European countries, Japan, Nordic countries- Denmark, Finland, Iceland, Norway and Sweden and the United States.
These guidelines inevitably vary somewhat in content and emphasis, but all are in consonant with regards to the prerequisites to be satisfied, and the principles to be applied as a basis for assuring the ethical and scientific integrity of clinical trials.
The guidelines are intended specifically to be applied during all stages of drug development, both prior to and subsequent to product registration and marketing, but they are also applicable, in whole or in part, to biomedical research in general.