ICH E6(R3) Updates: Operationalizing Risk Management in Clinical Operations

Wed, May 21, 2025 · 9:00–10:15 AM EDT Sheraton Boston Hotel

About this session

Delve into the updated ICH E6(R3) guidance and discover practical strategies for integrating risk-based methodologies into day-to-day clinical operations. This session will explore essential considerations, real-world examples, and best practices to streamline compliance while safeguarding participant welfare and data integrity.

Speakers

Carolina Hewell

Director, Head of Country Operations · Merck

Speaker
Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations · BioNTech

Speaker