Join industry leaders, regulatory experts and scientific innovators at the 6th Genotoxic Impurities: Nitrosamines & Beyond Summit. This premier two-day virtual event is dedicated to the latest developments, regulatory expectations and technical challenges in global impurity control.
Day 1 establishes the strategic framework for risk assessment. It features expert-led sessions on 2026 regulatory updates from the FDA and EMA, the qualification of drug substances and integrated in silico modeling. Discussions will highlight the newest structural risks, including the February 2026 Lhasa data-sharing initiative, CPCA potency categories and the ICH M7 purge factor strategy.
Day 2 focuses on the practical execution of testing and manufacturing. Sessions cover advanced trace-level analytical validation, high-sensitivity detection at ppb levels and formulation-based mitigation. Attendees will explore unique challenges in biologics, packaging leachables and cross-contamination risks, concluding with best practices for lifecycle management and post-approval change control.
