The summit offers a hybrid format:
- In-person: Milan, Italy
- Online: Live-streaming for remote participants
Choose your preferred participation option by clicking the “Register Now” button above.
Discover the advancements of impurity control at #Egenotoxic 2026. Explore the latest in genotoxic impurities, nitrosamine risk assessment, ICH M7/Q3D compliance, and pharmaceutical safety strategies — all in one trusted industry event.
Navigating Pharmaceutical Impurities: Trends, Challenges & Solutions at the 10th Impurities: Genotoxic, Nitrosamine & Beyond Summit (#Egenotoxic 2026)
Industry Impact of Nitrosamine ContaminationThe Valsartan recall due to N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) contamination marked a turning point in pharmaceutical impurity control. This crisis emphasized the urgent need for:
Comprehensive nitrosamine risk assessment
Robust strategies to mitigate mutagenic and carcinogenic impurities
Subsequent regulatory actions and recalls involving drugs like ranitidine, metformin, and varenicline have spotlighted the ongoing challenges in managing nitrosamines across the pharmaceutical supply chain.
Regulatory Evolution and Risk ManagementHeightened scrutiny from the FDA, EMA, and other agencies has driven updates to:
Integrated approaches for compliance with ICH M7 (R2) and Q3D updates — from lab to regulatory submission
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
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:
Discover the advancements of impurity control at #Egenotoxic 2026. Explore the latest in genotoxic impurities, nitrosamine risk assessment, ICH M7/Q3D compliance, and pharmaceutical safety strategies — all in one trusted industry event.
Your questions answered here.
The summit offers a hybrid format:
Choose your preferred participation option by clicking the “Register Now” button above.
Yes, session recordings are available for purchase as an optional add-on to your participation, allowing you to access all content after the event at your convenience.
Both in-person and online attendees can participate in numerous networking sessions, panel discussions, and Q&A sessions with industry experts. An event app will also be available, allowing delegates to arrange meetings and calls with other attendees, whether they are joining virtually or in person.
In-person attendees can enjoy coffee breaks with refreshments and lunches on both days, providing great opportunities to recharge and connect. On Day 1, all in-person participants are warmly invited to a networking dinner, perfect for fostering new connections in a relaxed setting.
All summit sessions will be presented in English. While translation services are not provided, we welcome attendees from around the world and encourage everyone to join the discussions and networking opportunities.
We’d love to help you make the most of the summit! You can request the summit brochure or contact our team directly using the details below. Our team is happy to answer any questions and guide you in planning your participation.
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