Featuring: Dave Nickerson, Head of Clinical Quality Management, EMD Serono
The transition from the previous ICH E6(R2) guidance to the new ICH E6(R3) represents one of the most significant updates to GCP in decades. With expanded flexibility, stronger alignment to ICH E8(R1), and deeper integration of quality-by-design and risk-proportionality principles, this revision aims to modernize clinical trial conduct for today’s evolving research landscape.
In this expert session, Dave Nickerson, Head of Clinical Quality Management at EMD Serono and a long-standing member of the ICH E6 Expert Working Group, breaks down what’s changing, why it matters, and how sponsors and sites should interpret the new expectations.
The discussion extends beyond simply defining what has changed in E6(R3). This session is designed to give clinical operations, quality, and regulatory teams the clarity they need to navigate the next generation of GCP requirements with confidence.
