2nd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond

The formation of nitrosamines as well as other mutagenic impurities in drug substances and drug products may
compromise their safety, quality, and clinical outcomes. Estimating impurity profiles, as well as controlling and
monitoring them, has become an unavoidable aspect of the comprehensive development and production of novel
medicines. The proactive detection of genotoxic impurities should be implemented at every step of drug development
to comply with growing regulatory standards and avoid costly recalls.

We organized an online discussion with industry experts to present and discuss various perspectives on how to
address the concerns of mutagenic impurities. We’ll go over 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.