ICH S5 – Updates and Implications

Date

Thursday, October 22, 2020
11:00 AM - 12:00 PM EDT (5:00 PM - 6:00 PM CEST)

Location

Online Webinar
Businessman hand touching REGULATION  sign on virtual screen

Overview

The first webinar in our series will look at the third revision of ICH S5 for the Detection of Reproductive and Developmental Toxicity. We will review what has changed, been added and/or harmonized with other guidance, and most importantly, what has not changed. You’ll also learn about exclusions for in vivo studies and incorporating alternative assays to support the 3Rs and keep your development program on track.

Even though the revision explicitly states it “does not apply to cellular therapies, gene therapies, and tissue-engineered products,” we'll use examples from our own experiences to explain how you can leverage ICH S5 to provide guidance on the potential for gene and cell therapies to affect the next generation.

There will also be time after the presentation to get your questions answered by our presenters.

 

Webinar Presenters

Alan Hoberman Headshot

Alan Hoberman, PhD, DABT, Fellow ATS
Executive Director, Global Developmental, Reproductive, and Juvenile Toxicology
Charles River


Mary Dougherty Headshot

Mary Dougherty, MSc, BSc
Research Scientist II
Charles River

 

View the other webinars in the series:

 
Have a scheduling conflict? Sign up even if you can't make it; we'll share the recording after.
 

We are providing digital education options to keep you learning about topics you may be interested in. For more information, visit criver.com/digital-education.