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23 - 24 September 2021



2021 ICH M7 Guideline for Genotoxicity Impurities, Software Evaluation Seminar


ICH M7 Guideline for Genotoxicity Impurities Software Evaluation Seminar

In this seminar, professionals from Lhasa Limited and Kang Yusheng evaluated the application of Lhasa's solutions to meet the ICH M7 guidelines, and explained how to deal with impurities based on the large amount of toxicological knowledge provided by Derek and Sarah Nexus using case studies. Dr. Qingfen Zhu from the Shandong Institute of Food and Drug Inspection shared his knowledge of basic toxic impurities. In addition, we discussed how to evaluate and control the nitrosamine impurities mentioned in the M7 guidelines with Lhasa experts. Zhu Zifeng, deputy general manager of Mingjie Pharmaceuticals, shared their research experience on nitrosamine impurities in drugs.

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