The summit will be held on March 04-5, 2026, in Milan and online.
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