The Academy of Toxicological Sciences (ACT) has announced an upcoming webinar titled “Overview of the Draft ICH Q3E Guideline”, scheduled for December 10, 2025. The session will focus on the newly released Step 2b ICH Q3E Draft Guideline for Extractables and Leachables, which entered public consultation on August 1, 2025 and will remain open through December 2025. Finalization of the guideline is currently targeted for June 2027.
Once completed, the ICH Q3E Guideline will become the first international standard dedicated to Extractables & Leachables (E&L). It is expected to introduce new safety-based qualification thresholds and establish a risk-based framework aligned with the principles of ICH Q9.
Expert Speakers
The webinar will feature insights from two leading experts from the U.S. FDA:
- Dan Mellon, PhD
Deputy Director, Division of Pharmacology/Toxicology for Neuroscience, Office of New Drugs, CDER, US FDA - Silvia H. De Paoli, PhD
Biological Reviewer, Office of Blood Research and Review (OBRR), CBER, US FDA
During the session, the speakers will review the history of the guideline, explain the scientific basis for the proposed thresholds, summarize key draft recommendations, and discuss the toxicological risk assessment approach for qualifying leachables in container-closure systems. The webinar will also highlight current challenges in E&L qualification.
Event Details
- Date: Wednesday, December 10, 2025
- Time: 11:30 AM – 1:00 PM Eastern Time
- Fee: Free of charge
- Registration: Advanced registration is required
Participants can register through the official link provided by ACT:
👉 https://www.actox.org/education/webinars.asp
