Better Together: How Principles, Annex 1, and Annex 2 Complete the ICH E6(R3) Picture

With the recent adoption of Annex 2, ICH E6(3) is now complete. For the first time, the industry has a fully modernized GCP framework—one that spans traditional interventional trials, decentralized approaches, pragmatic designs, and real-world data.

Each part plays a distinct role. The Principles set the foundation. Annex 1 delivers the operational framework for interventional trials. Annex 2 extends that framework to decentralized, pragmatic, and real-world data-driven designs. Used together, they form a flexible, modern GCP built for the trials we run today.

Register for this webinar to explore Annex 2 and how all three parts of E6(R3) work together when your trial design demands it, including:

• Annex 2 Unpacked: Decentralized elements, pragmatic designs, and real-world data—what’s new and what’s nuanced.
• Principles as the Backbone: The ethical and operational core that applies to every trial, no matter the design.
• Annex 1 and Annex 2 in Practice: How both complement each other when your trial blends traditional and decentralized elements.
• Quality by Design as the Connective Tissue: How QbD and proportionality principles guide decision-making across both Annexes.
• Getting Your Organization Ready: Practical steps for updating SOPs, training, and quality systems to reflect E6(R3) as one integrated framework.