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Uventia Global

Impurities may have a negative effect on the efficacy, safety, and quality of pharmaceutical components and products. The successful development and manufacturing of novel medications now depend heavily on the assessment of the impurity profiles as well as the management and monitoring of those. The diligent identification of nitrosamines and other genotoxic contaminants should be established at every step of drug development in order to comply with growing regulatory requirements and prevent costly recalls. Our online meeting, which we organized in collaboration with industry professionals, aimed to showcase and discuss different perspectives on addressing the challenges caused by mutagenic impurities. We will go over drug impurity profiling techniques that follow regulatory guidelines, as well as useful tips for adhering to recent updates to ICH M7 and Q3D, new nitrosamine regulations, nitrosamine impurities determination and calculation, risk assessment for genotoxic impurities, analytical challenges, development of acceptance criteria and most recent developments in elemental impurity assessment.

Email: info@uventia.com

GTIs, Genotoxic, Mutagenicity, Nitrosamines, Impurities, Regulatory Affairs, LC-MS, Mass Spectrometry, API, Process Chemistry, Drug Safety, Genetic, Toxicology

Massenspektrometrie, Chromatographie und Kernspinresonanzspektroskopie,    Genetik und Erbkrankheiten