6th Genotoxic Impurities Summit: Nitrosamines & Beyond 2026

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.

We Will Talk About

2026 Regulatory & Strategy
Key takeaways from EMA’s early 2026 Appendix 1 and the integration of nitrosamine oversight into routine inspection frameworks.
Establishing safety-based limits and utilizing ICH M7 purge factors to justify reduced batch testing.

Predictive Risk & Data Sharing
Using integrated in silico modeling (Derek/Sarah Nexus) and amine precursor mapping to identify DNA-reactive groups early.
Applying updated insights from the Lhasa initiative and CPCA frameworks to categorize complex NDSRIs.

Analytical Precision & Validation
High-resolution LC-MS/MS and GC-MS strategies capable of quantifying impurities at the parts-per-billion (ppb) level.
Validating trace-level methods to ensure specificity and accuracy for 2026-2027 audit standards.

Manufacturing & Lifecycle Controls
Mitigation through smart formulations, packaging E&L screening and managing cross-contamination from cleaning pitfalls or NOx levels.
Addressing unique risks in Biologics and maintaining compliance during post-approval site transfers and supplier changes.

Who Is It For?

The event covers key areas of product quality, regulatory compliance and manufacturing processes. The following departments would benefit from the insights shared at the conference:

Agenda 6th GTI Summit: Nitrosamines & Beyond 2026

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.