This virtual conference explored opinions on how to tackle the challenges of mutagenic impurities. Specifically, reviewing drug impurity profiling strategies in line with regulatory guidelines, practical insights for compliance with the recent updates in ICH M7 and Q3D, new nitrosamine regulations, determination and calculation of nitrosamine impurities, risk assessment of genotoxic impurities, analytical challenges and genotoxicity prediction, development of acceptance criteria, latest advances in the assessment of elemental impurities.
Principal Scientist, Mike Burns presented at this event on behalf of Lhasa Limited.