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.
In this session, you will hear directly from former regulatory and industry experts who contributed to the development of ICH S1B(R1). They will share practical experience on best practice, highlight common challenges in submissions, and explain how WoE assessments are being applied in practice.
The webinar will conclude with a case study from Lhasa Limited, demonstrating a structured and transparent approach that supports confident carcinogenicity assessment 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 attend?
- 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
Register today to secure your place and learn how to apply ICH S1B(R1) weight-of-evidence approaches with confidence.