In this video, Dr. Elsa Ferrão and Penelope Hutton discuss the evolving roles of sponsors and CROs in light of the updates to GCP ICH E6R3 guidelines. They delve into key concepts such as quality by design, risk-based approaches, and data governance, emphasizing the need for a paradigm shift in clinical trial oversight and management. The webinar also includes an interactive Q&A session, where the speakers address audience questions on implementing these new guidelines effectively.
The webinar focuses on the evolving roles of sponsors and CROs under the new ICH E6R3 guidelines, emphasizing quality by design, fitness for purpose, and risk-based approaches in clinical trials.
The importance of sponsor and investigator oversight is highlighted, with a focus on ensuring data quality and participant safety in clinical trials.
Data governance is a new section in ICH E6R3, providing a framework to manage data throughout the clinical trial process, emphasizing a proportionate risk-based approach.
