Implementing ICH E6(R3): Practical Risk-Proportionate Strategies for IRBs, Investigators, and Study Teams - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
(co-presented with PRIM&R)
Webinar
September 23, 2026 @ 1:00 pm – 2:00 pm
The MRCT Center is co-presenting a PRIM&R webinar on putting ICH E6(R3) into practice, and CIP credits are available. E6(R3) was adopted in January 2025 (Principles and Annex 1) and June 2026 (Annex 2). Quality by design, fit-for-purpose, risk proportionality, and essentiality of a record are now everyday vocabulary. What does that mean for IRBs, Investigators, and research teams? How do IRBs approach protocol review with a risk-proportionate lens? How do Investigators exercise appropriate oversight of research and determine which essential records should be maintained on file? David Nickerson, Head of Clinical Quality Management at EMD Serono and PhRMA Topic Lead for ICH E6(R3); Rebecca Stanbrook, Consultant at RESaltas GmbH, EFPIA Topic Lead for ICH E6(R3),; and Benjamin C. Silverman, MD, Senior IRB Chair in Human Research Affairs at Mass General Brigham, will lead the panel, moderated by Sarah White, MRCT Center Executive Director.