The Quality Issue – July 2025

Hot Topic: ICH E6(R3) is Official in Europe

ICH E6(R3) will become effective across the EU starting this Wednesday, July 23, as confirmed by the EMA. The FDA hasn’t set a date yet, but forward-thinking teams are already adjusting their processes. Staying proactive now can give you a critical edge in what’s coming next.

More than a routine update, this marks a meaningful evolution in how we think about clinical trial conduct. We’ve put together The Smart Guide to RBQM in ICH E6(R3), a free resource designed to help you cut through the complexity and turn guidance into action.
Download it here

Summer Focus: All Eyes on E6(R3)

Throughout the summer, we’re exploring the key updates and implications of ICH E6(R3). Breaking it down, sharing insights, and helping you implement the changes that matter. We’ll wrap things up with a live webinar at the end of the season, so watch this space for further details.

Article Spotlight: Transforming Clinical Trials with ICH E6(R3)
In this expert commentary from Justin Scott Brathwaite, MBA and Naresh Poondla, PhD, MBA, explain how ICH E6(R3) is set to reshape the clinical trial landscape. The new guideline focuses on flexibility, patient-centricity, decentralized trials, and digital tools to improve efficiency, data quality, and participant engagement. It also highlights the importance of risk-based quality management, stronger data governance, and clear role definitions to enhance compliance.
Read the full article