This webinar is a replay designed for our Japanese-speaking scientific community, with presentations available as recordings featuring embedded Japanese subtitles.
The ICH S1B(R1) addendum is a globally recognised guideline that introduces a weight-of-evidence (WoE) approach to assessing the carcinogenic potential of pharmaceuticals. It helps pharmaceutical organisations determine whether a two-year rat carcinogenicity study would provide additional insight into human safety.
Attendees heard directly from former regulatory and industry experts who contributed to the development of ICH S1B(R1). They shared practical experience on best practice, highlight common challenges in submissions, and explained how WoE assessments are being applied in practice.
The webinar concluded with a case study from Lhasa Limited, demonstrating a structured and transparent approach that supports confident decision-making, reduces unnecessary animal testing, and accelerates access to safe and effective therapies.
Meet the experts
- Dr Todd Bourcier – Former Regulatory Representative, ICH S1B Expert Working Group; Independent Consultant
- Dr Tim McGovern – Former Regulatory Representative, ICH S1B Expert Working Group; Independent Consultant
- Dr Ron Steigerwalt – Former Industry Representative, ICH S1B Expert Working Group; Independent Consultant
- Dr Alex Cayley – Principal Scientist, Lhasa Limited
Why watch?
- Gain first-hand insights from experts who shaped the guideline
- Learn how to address common challenges in ICH S1B submissions
- Hear how industry applies weight-of-evidence approaches in practice
- Discover a transparent scientific framework to support confident decision-making and regulatory acceptance