B15b. ICH GCP R3: Changes, Flexibility and Challenges
Tracks
Clinical & Regulation
| Wednesday, June 4, 2025 |
| 3:15 PM - 3:45 PM |
| Parkside 2 |
Chair & Speakers
Tanya Symons
Director
T Symons Associates Pty Ltd
ICH GCP R3: Changes, Flexibility and Challenges
Abstract
Over the past three decades, the administrative burden of clinical trials has increased significantly, often hindering progress and innovation. This session will explore the latest changes in the ICH E6 (R3) Guidelines, focusing on new concepts designed to enhance trial quality and efficiency. Attendees will gain practical insights into changes related to investigator and sponsor responsibilities, along with the potential challenges in implementing this important guideline.
Biography
Dr Tanya Symons is a highly experienced clinical trial consultant and an internationally recognised GCP expert. Tanya has delivered Clinical Trial and Good Clinical Practice (GCP) and ethics committee training to over 80,000 people.
In the UK, Tanya manages the internationally recognised NIHR Clinical Trials Toolkit. In Australia, Tanya works with governments, government-funded organisations and clinical trial sponsors to ensure that trial initiatives align with international best practice. She has authored or co-authored several national clinical trial guidelines, including the TGA Australian Clinical Trials Handbook, the NHMRC Safety Reporting and Serious Breach Guidelines and was the content writer for the ACTA/CTIQ Consumer Involvement and Engagement Toolkit.
