This webinar is specially prepared for the Japanese-speaking scientific community. Presentations will be delivered in English, with Japanese subtitles provided. It is designed for scientists, researchers, and regulatory professionals who want to strengthen their understanding of the ICH M7 guideline and its impact on the classification of mutagenic impurities.
By attending, you will:
- Gain up-to-date insights directly from regulators and industry experts.
- See practical demonstrations of in silico tools (Derek Nexus and Sarah Nexus) for impurity classification.
- Learn best practices for preparing and submitting ICH M7 risk assessments.
- Hear real-world case studies and strategies for addressing challenging impurity scenarios.
Speakers:
- Dr Roland Froetschl – Federal Institute for Drugs and Medical Devices
- Dr Robert Foster – Principal Scientist, Lhasa Limited
- Franny SwederGold – Senior Application Scientist, Lhasa Limited; formerly US FDA CDER
Agenda:
- Introduction to ICH M7 guidelines
Dr Roland Froetschl will introduce the ICH M7 guideline, outlining how expert-based and statistical systems can be combined to classify mutagenic impurities, and the advantages of applying in silico methods to new drug candidates. - Worked examples with Derek Nexus and Sarah Nexus
Dr Robert Foster will demonstrate how Derek Nexus and Sarah Nexus can be used together for ICH M7 classifications, offering a scientific perspective on impurity assessment strategies, including how to manage conflicting or out-of-domain results. - Regulatory best practice for ICH M7 Submissions
Drawing on her experience at the US FDA CDER, Franny SwederGold will provide practical guidance on regulatory expectations and best practice for ICH M7 risk assessment submissions. - Interactive Q&A Session
An opportunity to engage directly with the experts and ask your questions.
Why attend?
This is a unique opportunity for the Japanese scientific community to hear directly from regulatory and industry leaders on ICH M7 implementation, supported by practical case studies and tool demonstrations.