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10th Impurities: Genotoxic, Nitrosamine & Beyond Summit
Early bird price

10th Impurities: Genotoxic, Nitrosamine & Beyond Summit

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.

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Date4th – 5th Mar 2026
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PlaceMilan & Online, Italy
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VenueStarhotels Grand Milan
Price
from1 5991 799
calendar_month
Date4th – 5th Mar 2026
map
PlaceMilan & Online, Italy
location_on
VenueStarhotels Grand Milan

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:

Speakers

Dr. Raphael Nudelman, IL
Dr. Raphael Nudelman, ILConsultantNudelman ChemTox Consulting
Dr. Andrew Teasdale, UK
Dr. Andrew Teasdale, UKDirector (Former Head of Impurity Management & CMC Strategy at AstraZeneca)AT CMC Solutions Limited
Dr. Olivier Dirat, UK
Dr. Olivier Dirat, UKSenior Director, Global Regulatory Sciences CMC Advisory OfficePfizer
Dr. Alexander Amberg, DE
Dr. Alexander Amberg, DEHead of In Silico Toxicology/R&D Preclinical Safety FFSanofi Aventis Deutschland GmbH
Dr. Saroj Pau, IN
Dr. Saroj Pau, INAssociate Director, Analytical R&DNovartis

Event Preview

Key points

  • 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

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:

  • Pharmaceutical Development & Chemistry
  • Analytical & Laboratory Sciences
  • Impurities & Toxicology
  • Quality, Compliance & Regulatory
  • Emerging Technologies & Topics

Sponsors

Resolian
MEGGLE Excipients

10th Impurities: Genotoxic, Nitrosamine & Beyond Summit

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.

calendar_month
Date4th – 5th Mar 2026
map
PlaceMilan & Online, Italy
location_on
VenueStarhotels Grand Milan
Price
from1 5991 799

Industry about us

Maria from null
MariaBusiness Director

The organisation was wonderful, the presentations were really enlightening, from very important people of the field. This event is highly recommended and will definitely come next year as well!

Eleni from null
EleniCMC/Safety toxicologist, EUROTOX Member

🌟 What a great experience attending the "9th Impurities: Genotoxic, Nitrosamine & Beyond" summit in Vienna earlier this April! 🌟 The event featured exceptional speakers and an inspiring scientific community. I left with valuable insights and key takeaways that will undoubtedly impact my work.

Sara from null
SaraPreclinical Development Manager

It’s been almost a week since the conclusion of the inspiring 9th Impurities #Egenotoxic congress. I’m truly grateful for the opportunity to learn from outstanding professionals and to further strengthen connections with amazing colleagues. Quality and safety always go hand in hand, supporting each other to prevent risks and ensure the most technologically and scientifically safe product for human health.

Christina from null
ChristinaAnalytical Chemist

I had the incredible opportunity to participate in the 9th Impurities: Genotoxic, Nitrosamine & Beyond Summit I hashtag#Egenotoxic in Vienna. This two-day journey was a deep dive into the complex but fascinating world of nitrosamines. Exceptional scientists shared generously their expertise across a wide range of topics, from toxicological concerns and regulatory inconsistencies to analytical challenges... ... 👩‍🔬 I returned with valuable takeaways, new connections, and a renewed passion for continuing to learn and contribute to this vital and evolving area of research.

Keven from null
KevenToxicologist & Risk Assessor | Expert in Nitrosamines, Impurities & Exposure Limits | Supporting Global Pharma Compliance & Product Safety

Wrapping up an inspiring conference at the #Egenotoxic in Vienna. One key challenge echoed through many sessions: navigating a fragmented regulatory landscape. In particular, the ongoing inconsistencies around the acceptance of durational-based limits, whether for nitrosamines or non-mutagenic impurities, and the required supportive in vitro/in vivo genotoxicity testing continue to create a lot of uncertainty. As Dr. Lutz Mueller reminded us, carcinogenic risk is never as simple as a single number. Beyond mechanistic or epigenetic factors, it’s shaped by study design, biological variability, and interspecies differences. Over-simplifying that complexity can lead to over-conservatism, which also carries consequences for patients. On a more positive note, it was encouraging to hear that NDSRI test results so far suggest much lower potency than small dialkyl nitrosamines, hopefully paving the way for more pragmatic, science-based approaches. Stay tuned for some very promising work from Johnson et al. A special highlight for me was meeting David Ponting from Lhasa Limited, whose work I’ve long admired, and even managing to capture the moment! Grateful for the openness and generosity of everyone I connected with, and energized to keep learning, exchanging, and contributing to this fast-moving field.

Sophia from null
SophiaToxicology Lead

I appreciate the comprehensive approach #Egenotoxic takes — covering everything from cutting-edge analytical techniques to regulatory updates. It’s the perfect platform to stay ahead of industry challenges and network with top experts.

FAQ

Your questions answered here.

Will the summit be held in person or online?

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.

Can I access recordings after the summit?

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.

Are there networking opportunities?

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.

Will meals or refreshments be provided?

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.

What language will the summit be conducted in?

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.

How can I get more information?

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.

For any event assistance please contact

Gabriela Vladimirova
Gabriela VladimirovaSales & Marketing Manager