6th Nitrosamines & Beyond: Genotoxic Impurities Summit 2026

6th Nitrosamines & Beyond: Genotoxic Impurities Summit 2026 explores regulatory developments, risk assessment, analytical methods, and manufacturing strategies for controlling genotoxic impurities and ensuring pharmaceutical quality.

Key Topics

• Regulatory updates from the FDA and EMA
• Risk assessment and integrated in silico modeling
• ICH M7 purge factor strategy
• Lhasa data-sharing initiative and CPCA frameworks
• Trace-level analytical validation
• High-sensitivity LC-MS/MS and GC-MS detection
• Manufacturing mitigation and lifecycle management
• Packaging extractables and leachables screening
• Cross-contamination risk management
• Biologics impurity challenges
• Post-approval change control
• Safety-based limits for impurity control

Who should attend

• Regulatory affairs professionals
• Analytical scientists and chemists
• Toxicologists and safety assessors
• CMC and QA/QC experts
• Computational toxicology specialists
• Good manufacturing practice professionals
• Biologics and device developers
• Process development scientists
• Risk assessment professionals
• Nitrosamines specialists
• Analytical development professionals