The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Background
This webinar provides an overview of the TGA’s Good Clinical Practice (GCP) Inspection Program clinical trial compliance activities in 2023 - 2024. It will cover key areas of compliance and non-compliance with an opportunity to ask GCP inspectors questions to clarify compliance expectations. This webinar is based on the recent publication of our second GCP inspection metrics report.
The Good Clinical Practice Inspection Program (GCPIP) aims to strengthen the TGA’s monitoring activities and protect the safety and wellbeing of clinical trial participants. The GCPIP commenced inspecting trials of medicines and biologicals in 2022. The program was expanded to include medical device trials in November 2023.
GCP inspectors assess whether Australian clinical trial sites are meeting their GCP responsibilities. We can inspect all Australian clinical trial sites involved in clinical trials conducted under the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes. Inspectors verify compliance with the applicable Australian therapeutic goods legislation and guidelines.
Speakers
- Michelle Vo, Assistant Director, Pharmacovigilance Branch, TGA
- Anastasia Makshakova, Senior Good Clinical Practice (GCP) Inspector, Pharmacovigilance Branch, TGA
Webinar details
When: Friday 9 May 2025
Where: online webinar
Time: 12:30 - 1:30pm AEST