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.
Alan Hoberman, PhD, DABT, Fellow ATS
Executive Director, Global Developmental, Reproductive, and Juvenile Toxicology
Mary Dougherty, MSc, BSc
Research Scientist II
View the other webinars in the series:
- The Guidelines and Challenges of Performing NHP DART Studies (October 29)
- Rodents and Rabbits - The Traditional DART Models (November 5)
- The Role of Dogs and Minipigs in DART Programs (November 12)
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.