CONFERENCE OVERVIEW
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.
Book your spot for our webinar to learn about best practices and innovative approaches to genotoxic and other mutagenic impurities control.
