4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024

CONFERENCE OVERVIEW

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.

Reserve your spot for this informative webinar so that you can leave with new ideas and best practices for managing genotoxic and elemental impurities.

WE WILL BE FOCUSING ON

• nitrosamine impurity risk assessment to reduce costs and accelerate timelines
• minimizing nitrosamine contamination - from raw materials to finished products
• appropriate analytical tools for nitrosamine impurity detection
• practical and compliant application of ICH M7 and ICH Q3D guidance
• impurity profiling of pharmaceutical ingredients, intermediates and finished products
• E&L as an impurity source - mitigating the risk that comes with E&L

WHO IS IT FOR?

CxO, VP, Directors, Heads, Managers of

• Genotoxic Impurities/ GTIs/ Genotoxins/ Elemental Impurities
• Genotoxicity/ Mutagenicity
• Carcinogenicity/ Carcinogens
• Genetic Toxicology/ Chemical Toxicology/ Computational Toxicology
• Analytical Chemistry/ Analytical Development/ Analytical Science
• Drug Discovery/ Drug Development/ Drug Substance
• Drug Safety/ Compound Safety
• Process Chemistry/ Process Development
• Product Characterisation/ Risk Assessment
• Pharmacokinetics/ Metabolism
• Extractables & Leachables
• API Development/ Degradation Products
• LC-MS/ Mass Spectrometry
• Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP)
• Regulatory Affairs & Compliance

[Agenda] 4^th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.