Webinar
Date: September 23, 2026
Co-presented with PRIM&R (Public Responsibility in Medicine and Research)
ICH E6(R3) moves Good Clinical Practice toward quality by design and risk-proportionate oversight. This webinar looks at what that shift means for the people who review, run, and document clinical trials: IRBs, investigators, and study teams. The panel discusses what is changing, how the guideline relates to the US regulations that govern IRB review, the move from investigator supervision to investigator oversight, and how to decide which essential records a trial needs. The panel then applies these ideas to a case study: an investigator-initiated trial of an approved drug in a new indication for a rare neuromuscular condition, run at three sites under a single reviewing IRB.
Panelists
- David Nickerson, VP, Head of Clinical Quality Management, EMD Serono, and PhRMA Topic Lead for ICH E6(R3)
- Rebecca Stanbrook, Founder and Director, RESaltas GmbH, and EFPIA Topic Lead for ICH E6(R3)
- Benjamin C. Silverman, MD, Senior IRB Chair, Mass General Brigham
Moderator
- Sarah White, Executive Director, MRCT Center