6th Genotoxic Impurities Summit: Nitrosamines & Beyond 2026
As global regulatory expectations and technical challenges in impurity control continue to evolve, this premier two-day virtual event will bring together leading industry experts, regulatory authorities, and scientific innovators.
Summit Highlights:
Day 1 (December 2nd): Focuses on the strategic framework for risk assessment, featuring expert-led sessions on 2026 regulatory updates from the FDA and EMA, the qualification of drug substances, integrated in silico modeling, structural risks (including the Lhasa data-sharing initiative), CPCA potency categories, and the ICH M7 purge factor strategy.
Day 2 (December 3rd): Centers on the practical execution of testing and manufacturing, covering advanced trace-level analytical validation, high-sensitivity detection at ppb levels, formulation-based mitigation, unique challenges in biologics, packaging leachables, cross-contamination risks, and post-approval change control.
This summit is specifically designed for professionals involved in impurity profiling, risk assessment, regulatory compliance, and pharmaceutical development.
It would be an honor for us if you participated in this important industry event and joined us online!
