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Dealing with Pharmaceutical Impurities: An Integrated Approach
Dec 9, 2013, 8:30AM to 5:30PM
|Details||The SMi Group, in association with Xiphora Biopharma Consulting and IEXA 100 Consulting, proudly present a master class on Dealing with pharmaceutical impurities: an integrated approach.
Dealing with pharmaceutical impurities is becoming increasingly problematic due to a variety of factors including: enhanced regulatory focus particularly on potentially mutagenic impurities, availability of extremely sensitive assay methods, and development of new ICH guidelines.
SMi's masterclass hosted by Xiphora Biopharma Consulting and IEXA 100 Consulting, is intended to help delegates perform an integrated assessment of impurities by data collation, toxicological and pharmaceutical evaluation and guideline navigation. In many cases there are “smart” solutions to impurity issues that can greatly minimise the time and expense involved with more conventional approaches.
Key Topics Include:
• Scientific and regulatory aspects of impurities
• Common pitfalls when dealing with pharmaceutical impurities, and how to avoid them using “smart” solutions
• Focus particularly on mutagenic impurities in relation to the upcoming ICH M7 guidance.
Keywords: pharmaceutical evaluation, genotoxicology, toxicological, qualification strategy, ds/dp, toxicologist, non-mutagenic, m7 guidance, ich, mutagenic impurities, toxicology, genotoxic, pharmaceutical impurities, cmc.
|Venue||Holiday Inn Bloomsbury|