The ICH GCP R3 Roadmap: Changes and Challenges of ICH E6 (R3) – Are you ready?

In the EU, the ICH Guideline E6 (R3) will be effective on 23 July 2025. The guideline underwent a major restructuring and modernisation. The risk-based and risk-proportionate approach has been introduced into every aspect of a clinical trial and modern techniques like the use of computerized systems (e.g., eCRF, eTMF, eConsent), as well as remote Source Data Verification are now included in the Guideline. Data Governance plays an important role, not only for sponsors but also for investigators.

Although the GCP wheel has not been re-invented, we all need to get familiarised with the new approaches and elements of the Guideline. The approximate 6 months between the adoption of the Guideline by the EMA and the coming into effect should be smartly used to get your teams trained, to revisit your SOPs and to bring them up-to-date. Solid knowledge of the changes and challenges of the new Guideline will ease the revision of your GCP Quality Management System (QMS).

Don’t miss this EUCROF Webinar – you, your QMS, your clinical trials and ultimately the trial participants will benefit from your good GCP knowledge.