mindsON RBQM | Episode 32: The new ICH E6(R3) has landed!

The long-anticipated ICH E6(R3) revision has officially been adopted, introducing significant changes to Good Clinical Practice (GCP) and setting a new standard for how clinical trials are designed, conducted, and overseen. But how will these updates affect the industry’s current approaches to Quality by Design (QbD) and Risk-Based Quality Management (RBQM)?

In this mindsON RBQM session, our seasoned experts Johann Proeve and Keith Dorricott will walk you through the key changes and what they mean for your clinical operations. From proactive quality measures and enhanced roles and responsibilities to broader acceptance of decentralized elements, this session will offer a deep dive into how organizations can adapt and thrive under the new guidelines.

This interactive session also invites attendees to actively participate through live polls and whiteboards, providing a platform to share thoughts, ask questions, and engage with fellow professionals. Whether you’re new to RBQM or a seasoned practitioner, this workshop offers valuable perspectives to help you navigate the evolving regulatory landscape.

What you’ll gain:

• A practical breakdown of the key changes introduced by ICH E6(R3)

• Expert perspectives on how the revision affects QbD and RBQM implementation

• Interactive polling and whiteboard discussions to share your insights and challenges

• Guidance on what steps to take now to stay compliant and future-ready

Whether you’re overseeing clinical operations, managing quality systems, or implementing RBQM tools, this session is your chance to stay ahead of regulatory shifts and engage directly with thought leaders in the field.

Join us and be part of the conversation shaping the future of quality in clinical trials.