The 5th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond addresses the assessing and controlling of the risk of nitrosamines.
Topics
- Reducing nitrosamine contamination from raw materials to finished drugs
- Nitrosamine impurity risk assessment to optimize timeframes and costs
- Practical and compliant implementation of ICH M7 and ICH Q3D guidance
- Appropriate analytical instruments for detecting nitrosamine impurities
- E&L as an impurity source – removing the risks associated with E&L
- Impurity profiling in drug substances, intermediates, and drug products
Who should Attend
Senior attendees with responsibilities in:
- Genotoxicity/ Mutagenicity
- Genotoxic Impurities/ GTIs/ Genotoxins/ Elemental Impurities
- Genetic Toxicology/ Chemical Toxicology/ Computational Toxicology
- Carcinogenicity/ Carcinogens
- Drug Discovery/ Drug Development/ Drug Substance
- Analytical Chemistry/ Analytical Development/ Analytical Science
- Process Chemistry/ Process Development
- Drug Safety/ Compound Safety
- Pharmacokinetics/ Metabolism
- Product Characterisation/ Risk Assessment
- API Development/ Degradation Products
- Extractables & Leachables
- Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP)
- LC-MS/ Mass Spectrometry
- Regulatory Affairs & Compliance
