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Classification of potentially mutagenic impurities under the ICH M7 guideline

Join our Lhasa webinar to deepen your understanding of the ICH M7 guidelines and their application in classifying mutagenic impurities.

 

Learn from regulatory and industry leaders through expert presentations and real-world case studies. The webinar agenda includes:

Introduction to ICH M7 guidelines
Dr Roland Froetschl, from the Federal Institute for Drugs and Medical Devices, will open the webinar by introducing the ICH M7 guidelines and explain how expert-based and statistical systems can be used together to classify mutagenic impurities. Roland will also discuss the benefits of using in silico methods for assessing new drug candidates.

Demonstration of Derek Nexus and Sarah Nexus
Dr Robert Foster, Principal Scientist at Lhasa Limited will introduce Derek Nexus and Sarah Nexus and discuss how they can be combined to provide an overall ICH M7 classification. Robert will demonstrate how Nexus can support expert review which is important for all predictions used in a regulatory submission.

Industry case study:
Dr Alyssa Musso, Global Risk Assessment Services Toxicologist within Drug Safety Research and Development at Pfizer will demonstrate a detailed case study showcasing how Pfizer implements Derek Nexus and Sarah Nexus for ICH M7 submissions.

Why attend?
1. Learn from leading experts in the field of drug and medical device safety for DNA mutagenic impurity classification.
2. See cutting-edge in silico expert-based and statistical tools in action.
3. Understand how top pharmaceutical companies apply ICH M7 guidelines to real-world case studies.
4. Have your questions answered by ICH M7 experts during the live Q&A session.

The webinar will run for approximately two hours and will conclude with an interactive live Q&A session. Register to attend using the form below!

 

 





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