With the recent implementation of the revised ICH E6 (R3) guidelines, this course offers a practical overview of the rationale and key implications of this revision - the most significant in over two decades.

Participants will explore the driving forces behind these changes, including technological advances, the latest developments in alternative clinical trial designs and the use of real-world data sources.

By the end of the course, participants will understand how the revised guideline provides a framework that supports fit-for-purpose clinical trial design, the use of new technologies and alternative operational strategies. They will also gain a thorough understanding of the key principles and expectations for proportionate, risk-based quality management of clinical trials and return to their roles with practical, concrete solutions for effective implementation of this revised guideline.

The course is delivered by GCP experts from both regulatory authorities and industry, who bring deep insight into the current clinical trial landscape. Drawing on their expertise, they explore the practical application of GCP across a range of scenarios from trial design to trial reporting.

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 14 May 2025 latest. Submit your questions to training.emea@diaglobal.org.