The ICH M7 guideline provides a framework to identify, categorize, qualify, and control mutagenic impurities in drug substances and drug products. The intention is to allow sponsors to establish levels of mutagenic impurities that are expected to pose negligible carcinogenic risk to patients. This is accomplished with the use of experimental data and/or in silico tools along with expert review to ensure proper classification and control of mutagenic impurities. This webinar will present an overview of the approaches required to screen impurities for mutagenic potential along with insights and case studies that highlight the need for knowledgeable toxicology support for this important task.

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