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.
Speakers
Claire Riches, VP 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.
Message Presenter
Pierre Mermet-Bouvier, PhD, Senior Manager, eClinical Strategy & Delivery, ICON plc
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.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following roles or areas of expertise:
- Clinical Operations/Clinical Development
- Clinical Research/Clinical Affairs/Clinical Strategy
- Study Management/Patient Recruitment
- Patient and Site Engagement
- Regulators/Regulatory affairs
- Therapeutic Heads/Patient Advocacy Leaders
- Medical Affairs
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
Xtalks Partner
Citeline
Citeline, a Norstella company, powers a full suite of complementary business intelligence offerings to meet the evolving needs of life science professionals to accelerate the connection of treatments to patients and patients to treatments. These patient-focused solutions and services deliver and analyze data used to drive clinical, commercial and regulatory-related decisions and create real-world opportunities for growth.
Citeline’s global teams of analysts, journalists and consultants keep their fingers on the pulse of the pharmaceutical, biomedical and medtech industries, covering it all with expert insights: key diseases, clinical trials, drug R&D and approvals and market forecasts. For more information on one of the world’s most trusted health science partners, visit Citeline.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account