Discover how the new ICH GCP E6(R3) guidelines are transforming clinical trials with a focus on patient-centricity, digital innovation, and risk-based quality management. Join this webinar to explore key changes and their impact on sponsors, CROs, investigators, and ethics committees.
The new ICH GCP E6(R3) guidance, effective July 2025, signals a significant shift towards more flexible, patient-centered and digitally supported clinical trials. With only 11 streamlined principles, E6(R3) emphasizes proportional risk management, robust data governance and clearer stakeholder responsibilities — all while prioritizing patient safety and data integrity.
But who does this impact? In short, everyone. Sponsors must now implement risk-based quality systems and maintain oversight even when outsourcing. CROs and service providers face increased expectations for innovation and compliance. Investigators and trial sites must demonstrate realistic recruitment capabilities and manage data with precision and accuracy. Furthermore, ethics committees are tasked with reviewing digital consent and recruitment materials, and patients are at the center of trial design, engagement and retention.
The featured speaker in this webinar will highlight the key elements of the new guidelines and explore their real-world implications for clinical research stakeholders.
Register for this webinar to learn how ICH GCP E6(R3) is reshaping global clinical trial standards and expectations.
What You Will Learn
Attendees will learn about:
What’s Changing: Get the inside scoop on the new ICH GCP E6(R3) guidelines and why they matter
Who’s Affected: See how sponsors, CROs, sites, ethics boards and patients are impacted
What Needs to Be Done: Explore practical approaches to more intelligent risk management and data governance to stay compliant
What’s The Opportunity: Find out how to turn regulatory change into strategic advantage and growth
Featured speakers
Claire Riches
VP of Clinical Solutions, Citeline
Claire Riches brings over 25 years of pharmaceutical experience to help biotech teams run faster and smarter trials. At Citeline, she leads with deep expertise in clinical research, commercial strategy and therapeutic leadership, turning complex data into clear, AI-driven clinical solutions. Claire is passionate about using data and AI to drive better decisions, particularly in patient recruitment, trial diversity and increasing the chances of success.
Pierre Mermet-Bouvier, is currently Senior Manager, eClinical Strategy & Delivery, at ICON plc. He held senior positions in global pharmaceutical & CRO companies for 30 years, in Clinical Operations, Project Management Office, Regulatory Affairs & Long-Range Planning. He has a long history of Regulatory Intelligence & information sharing.