B02. TGA Clinical Trial Initiatives
Tracks
Clinical Research
| Wednesday, June 4, 2025 |
| 11:15 AM - 12:15 PM |
| Pyrmont Theatre |
Chair & Speakers
Tessa Sherry
Acting Director Pharmacovigilance Compliance and CT Section. Department of health and Aged Care, TGA
TGA, Pharmacovigilance Branch
B02. TGA Clinical Trial Initiatives
Abstract
The TGA has invested in the improvement of the clinical trials environment with a particular focus on regulatory efficiency and Good Clinical Practice (GCP). This session will provide information on the TGA’s recent clinical trials initiatives, including the Clinical Trial Approval scheme review, High-risk Device Reforms and their evaluations, insights from our 2024 GCP inspection program metrics report and the TGA and Human Research Ethics Committee discussion forum
Biography
Dr Tessa Sherry is the acting Director of the Pharmacovigilance Compliance and Clinical Trials Section, which is responsible for managing the clinical trial notification and approval schemes, as well as the pharmacovigilance and Good Clinical Practice inspection programs. She has a PhD in genetics and biochemistry. Since joining the TGA in 2020, Tessa has worked across regulation of biologicals, prescription medicines and clinical trials.
