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1 - 2 December 2022



2nd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond


2nd Annual Genotoxic Impurities Summit Nitrosamines and Beyond

Uventia organised an online discussion with industry experts to present and discuss various perspectives on how to address the concerns of mutagenic impurities. The agenda also covered drug impurity profiling strategies that follow regulatory guidelines, as well as practical tips for complying with recent updates in ICH M7 and Q3D, latest nitrosamine regulations, nitrosamine impurity identification and quantification, risk assessment of genotoxic impurities, analytical complexities and genotoxicity prediction, development of acceptance criteria, and the most recent progress in the examination of elemental impurities.

Lhasa Principal Scientist, Michael Burns provided a presentation.

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