This information may be of interest to:
-Research and academic institutions conducting clinical trials
-Sponsors and other members sponsoring or involved in clinical trials
The TGA will provide an overview of the new Guidance for GCP Inspection of clinical trial sites for investigational biologicals and medicinal products via an online webinar, to be held on Tuesday 28 June 2022, 1pm-2pm. Click here to register.
This webinar follows the recently published Guidance on the TGA website for Good Clinical Practice (GCP) inspection of clinical trial sites for medicinal products. The guidance describes how the TGA prioritise and schedule GCP inspections; the kinds of inspections the TGA might conduct; the inspection process, and how the TGA report and follow-up on inspections.
While CMA is aware that currently the TGA prioritise inspections for high risk products such as prescription medicines or biologicals, meaning CM trials may not be inspected, the information at the webinar and in the guidance is nonetheless valuable for those conducting trials.
CMA recommends attending the webinar that if you are conducting or sponsoring clinical trials for complementary medicines. Please also see CMA’s 28 April technical alert for more information.