OVERVIEW

10th Impurities: Genotoxic, Nitrosamine, & Beyond Summit is organized by Vonlanthen Group of Companies and will be held from Mar 04 - 05, 2026 at Milano, Lombardia, Italy.

Description:
The 10th Impurities: Genotoxic, Nitrosamine & Beyond Summit I #Egenotoxic 2026 is one of the most respected and widely attended gatherings in the field of pharmaceutical impurity control. Trusted by leading experts, regulators, and innovators across the industry, this renowned event is where the global pharma community comes together to tackle the most pressing challenges around nitrosamines, genotoxic impurities (GTIs), and regulatory compliance. Known for its depth, clarity, and practical takeaways, the summit sets the standard for excellence in ICH M7 and Q3D implementation, risk assessment, and analytical science.

Key Practical Learning Points

Integrated approaches for compliance with ICH M7 (R2) and Q3D updates — from lab to regulatory submission
Nitrosamine risk evaluation beyond legacy products: understanding new nitrosamine classes, degradation pathways, and cross-contamination risks
Case-based insights from recent recalls, inspections, and FDA/EMA enforcement actions
Advanced analytical methods: real-time monitoring, AI-supported impurity profiling, and next-gen LC-MS tools
Evolving regulatory expectations on cohort of concern impurities, nitrosamine drug substance-related impurities (NDSRIs), and carcinogenic potency categorization
Bridging toxicological data gaps with novel in silico modeling, TTC thresholds, and read-across approaches
Mutagenic impurities control in biologics, oligonucleotides, and mRNA products
Cross-functional strategies to align QA/QC, regulatory, and manufacturing teams under a unified impurity control framework
Enhanced extractables & leachables (E&L) strategies for genotoxicity risk management, including nitrosamine migration in packaging
Insights into future frameworks: WHO, EDQM, EMA & FDA harmonization, and what it means for your product pipeline