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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, attendees heard directly from former regulatory and industry experts who contributed to

We held this webinar all about supporting forced degradation studies with in silico tools as part of your workflow. With Senior Scientist Jonathan Lockett, this session covered four case studies demonstrating how in silico solution Zeneth can support confident interpretation of forced degradation studies and subsequently result in stress-free submission to regulators. The case studies

We held this webinar all about supporting forced degradation studies with in silico tools as part of your workflow. With Senior Scientist Jonathan Lockett, this session covered four case studies demonstrating how in silico solution Zeneth can support confident interpretation of forced degradation studies and subsequently result in stress-free submission to regulators. The case studies

This event has now finished. If you’re interested in Vitic Q3D and the problems it solves during Q3D risk assessment workflows, download our latest infographic detailing three common problems experienced by our valuable members during ICH Q3D risk assessment.   This session provided a comprehensive overview of the ICH Q3D guidelines, which are designed to

We held this practical, workshop-style webinar designed to help you confidently apply in silico tools for ICH M7 risk assessments. This session was ideal for professionals involved in the evaluation of potentially mutagenic impurities, whether you’re new to in silico methods or looking to deepen your expertise. We walked through real compound examples using Derek

9 am (Mexico – CST), 10am (Colombia – COT), 12 pm (Argentina – ART) This Spanish-language webinar guided attendees through real-life case studies using the in silico tool Zeneth to solve stability problems at various stages of the drug development workflow. Case studies included: Nitrosamine risk assessment Identification of degradants Regulatory deficiency letter troubleshooting The webinar

Please note this webinar was hosted in Japanese. 15:30 (JST) In this webinar we explored the scientific and regulatory challenges of applying ICH M7 Control Options 3 and 4 to manage nitrosamine impurities in pharmaceuticals. Drawing on real-world case studies from the recently published journal article Industrial Case Studies Demonstrating Applicability of ICH M7 Control

니트로사민 관리 전략 – ICH M7 옵션 3 및 4의 실제 적용 Please note this webinar will be in Korean, or dubbed in Korean with Korean subtitles only. 15:30 (KST) In this webinar from Lhasa Limited and BITEK, we explore the scientific and regulatory challenges of applying ICH M7 Control Options 3 and 4 to

Regulatory frameworks like ICH M7 have established in silico tools as a trusted method for evaluating the mutagenic potential of impurities, reducing reliance on animal testing and accelerating risk assessments. While these tools are widely accepted for mutagenicity, researchers and regulators are now looking at their potential for broader genotoxicity evaluations, including chromosome damage. As