Key Practical Learning Points

  • Integrated approaches for compliance with ICH M7 (R2) and Q3D updates — from lab to regulatory submission

  • Nitrosamine risk evaluation beyond legacy products: understanding new nitrosamine classes, degradation pathways, and cross-contamination risks

  • 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

Introduction:
The pharma industry is under sharper scrutiny than ever before. In the wake of expanding nitrosamine recalls, stringent regulatory updates, and newly discovered impurity risks, companies must rethink traditional risk assessments and analytical strategies. The landscape is no longer about meeting minimum standards — it's about staying ahead of evolving expectations.

#Egenotoxic 2026 brings together experts at the forefront of impurity science, regulatory policy, and pharmaceutical manufacturing. We go beyond nitrosamines to tackle a spectrum of genotoxic impurities (GTIs) and their impact on product safety, global compliance, and innovation.

This year’s summit will feature the latest investigations, including:

  • Unexpected nitrosamine formation routes
  • Data integrity challenges in impurity control
  • Root cause analysis in regulatory warning letters
  • Real-world remediation case studies

You'll gain access to leading-edge science and the tools to:

  • Reduce product risk
  • Future-proof your impurity strategy
  • Respond confidently to audits and regulatory queries