Past

This session provided a comprehensive overview of the ICH Q3D guidelines, which are designed to ensure patient safety by limiting exposure to potentially harmful elemental impurities in pharmaceutical products. Experts discussed what the guidelines mean to key teams, from regulatory affairs to quality teams, across the entire product lifecycle and how the automated principles within […]

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