4th Annual Genotoxic Impurities in Pharmaceuticals Summit 2024

Conference Overview

For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, what may cause mutations, potentially leading to cancer. Due to this fact and focusing on ensuring safety of public health is critical to identify, monitor, analyse and control genotoxic impurities and strive to their minimum level. This has led to the crucial need in the development and improvement of analytical methods.

The Genotoxic Impurities in Pharmaceuticals Summit 2024 is focusing on overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, exposure limits calculation and predictions' empowerment through in silico.

The featured talks on:

• Nitrosamines and the cohort of concern - how to place under ICH M7? An industry perspective
• The Need for a Non-targeted Screening Approach to Nitrosamine Analysis
• N Nitrosamines – Complex – API like N Nitrosamines – current realities and threats
• Analytical approaches to cover potentially harmful Impurities in drug formulations
• Exploring the scale of potential nitrosamine risk associated with existing approved APIs
• Management of N-Nitrosamines and their risk assessment within GSK R&D
• Nitrosamines 2.0: The challenge and impact of nitrosamine trace analysis across the pharmaceutical industry
• Quantitative analysis of in vivo mutagenicity dose-response data for risk assessment and regulatory decision-making: a case study of alkylnitrosamines.
• Technologies for Optimising Performance, Minimising Risk and preparing for the Future in Trace Impurity Quantification
• Setting Limits for Complex Nitrosamines (NDSRIs)
• Incorporating Nitrosamine Risk Mitigation Activities Across a Diverse Development Portfolio
• Inhibition of Nitrosamine Formation in Drug Products
• Impact of different rat or hamster S9 fractions on the metabolic activation of low-molecular-weight N-nitrosamines – a comparative analysis
• Optimisation of Nitrosamine analysis in pharmaceutical elastomers
• Case Studies of Nitrosamines in Pharmaceuticals
• Recent updates on Nitrosamine Impurities by EMA & FDA
• Enhancing nitrosamines analysis: a focus on complex nitrosamines (NDSRIs or NO-APIs)
• How Sanofi scientists streamlined their in silico hazard assessment of potential genotoxic impurities by collaborating with Discngine
• Expert Review of In Silico Mutagenicity Predictions
• Development of in silico systems for expert review under ICH M7 guideline: increasing efficiency through automated arguments
• Analytical Strategies for Enhancing Selectivity and Sensitivity of Genotoxic Impurities
• Ongoing Efforts to Optimize the Ames Assay by the HESI-GTTC Mechanism-based Genotoxicity Risk Assessment (MGRA) Nitrosamine Subgroup
• Applications of computational methods in the assessment of extractables and leachables