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10th Impurities: Genotoxic, Nitrosamine, & Beyond Summit

  • 4th – 5th March 2026
  • Italy flag Italy Milan & Online

The 10th Impurities: Genotoxic, Nitrosamine & Beyond Summit I #Egenotoxic 2026 is one of the most respected and widely attended gatherings in the field of pharmaceutical impurity control. Trusted by leading experts, regulators, and innovators across the industry, this renowned event is where the global pharma community comes together to tackle the most pressing challenges around nitrosamines, genotoxic impurities (GTIs), and regulatory compliance. Known for its depth, clarity, and practical takeaways, the summit sets the standard for excellence in ICH M7 and Q3D implementation, risk assessment, and analytical science.

Every year, professionals from across pharma, biotech, and regulatory sectors look to #Egenotoxic for cutting-edge insights into N-nitrosamine detection, mutagenic impurity limits, cohort of concern substances, and emerging risk pathways. This milestone 10th edition will feature in-depth sessions on toxicological modeling, CMC strategy, and global regulatory trends, extractables and leachables (E&L). Taking place in Milan and online on March 4–5, 2026, it’s more than a conference — it’s the meeting point for those shaping the future of pharmaceutical quality, safety, and innovation.

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Navigating Pharmaceutical Impurities: Trends, Challenges & Solutions at the 10th Impurities: Genotoxic, Nitrosamine & Beyond Summit (#Egenotoxic 2026)

 

Industry Impact of Nitrosamine Contamination


The 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 Management

Heightened scrutiny from the FDA, EMA, and other agencies has driven updates to:

  • ICH M7 and Q3D guidelines
  • Revised acceptable intake (AI) limits for nitrosamine impurities

Industry stakeholders must integrate nitrosamine risk assessments into:

  • Drug substances (DS)
  • Drug products (DP)
  • Packaging materials

Collaboration among pharmaceutical manufacturers, excipient suppliers, toxicologists, and regulators is essential to develop effective control strategies and address knowledge gaps.

 

Expanding Focus Beyond Nitrosamines


At #Egenotoxic 2026, the conversation broadens to include:

  • All genotoxic impurities (GTIs)
  • Elemental impurities
  • Extractables and leachables (E&L)
  • Other mutagenic substances

 

The summit will cover:

  • Advanced analytical techniques
  • Toxicological evaluations
  • Evolving regulatory requirements

This will help attendees navigate complex impurity profiles and optimize quality control processes.

 

Register Now for #Egenotoxic 2026 and Stay Ahead of Pharmaceutical Impurity Challenges

Join us on March 4–5, 2026, in Italy, Milan or online to:

  • Tackle critical challenges including nitrosamine contamination and evolving ICH M7/Q3D regulations
  • Manage complex genotoxic impurities (GTIs)
  • Explore the latest advancements in analytical technologies, risk assessment, and pharmaceutical quality control
  • Gain actionable insights and practical strategies
  • Build valuable connections with industry leaders, researchers, and regulators

Secure your spot today and ensure you’re equipped to navigate the rapidly evolving pharmaceutical impurity landscape.

Participants at #Egenotoxic 2026 will receive a digital certificate of attendance.

 

Who Should Attend:

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

Pharmaceutical Development & Chemistry

  • Drug Discovery, Design & Development
  • Active Pharmaceutical Ingredient (API) Development
  • Process Chemistry & Organic Synthesis
  • Formulation & Purification
  • Large Molecules, Peptides, Oligonucleotides, Biotherapeutics, New Modalities

Analytical & Laboratory Sciences

  • Analytical Science & Assay Development
  • Chromatography, LC-MS, Mass Spectrometry, Spectroscopy
  • Microscopy
  • Extractables & Leachables (E&L)
  • Validation & Technology Transfer

Impurities & Toxicology

  • Genotoxic Impurities (GTIs), Mutagenic & Carcinogenic Impurities
  • DNA Reactive Impurities, DNA Reactivity, Genetic Toxicology
  • N-nitrosamine Drug Substance-Related Impurities (NDSRIs)
  • Process-Related & Product-Related Impurities
  • Potential Genotoxic Impurities (PGTIs)
  • Threshold of Toxicological Concern (TTC)
  • Toxicology, Safety Assessment, Preclinical Drug Safety

Quality, Compliance & Regulatory

  • Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP)
  • Quality Assurance (QA), Quality Control (QC), Quality by Design (QbD)
  • Regulatory Affairs & Compliance
  • Risk Assessment & Total Daily Intake (TDI)

Emerging Technologies & Topics

  • Nanomaterials & Nanoparticles
  • In Silico Modeling
  • Purge Factors
  • Carcinogenicity & Carcinogens

Register by 31.08.2025

First Early Bird tickets available

The Early Bird Offer expires in 64 days!

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

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

Register by 31.08.2025

First Early Bird tickets available

The Early Bird Offer expires in 64 days!

Dr. Andrew Teasdale, UK

Director (Former Head of Impurity Management & CMC Strategy at AstraZeneca)

AT CMC Solutions Limited 

Andrew Teasdale, PhD till recently was a senior principal scientist in impurity management and external advocacy at AstraZeneca. Andrew has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his recent role, he was chairing AstraZeneca’s impurity advisory group. Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He also published a book addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control,’ (Wiley and Son) and is soon to publish as editor a book focused on practical implementation of ICH quality guidelines.

Dr. Raphael Nudelman, IL

Consultant

Nudelman ChemTox Consulting

Raphael (Raphy) Nudelman is a chemical toxicologist with over 20 years of industry experience. He holds a PhD in organic chemistry from the Weizmann Institute of Science and completed postdoctoral research at the US Air Force Research Lab and Duke University Medical Center. At Teva Pharmaceutical Industries, Raphy held various roles, including in the medicinal chemistry department, the patent department, the non-clinical safety department, and as the Impurity Expert of the company. His expertise spans impurity and excipient qualification in drug substances and drug products, with a recent focus on risk assessment of nitrosamine impurities in pharmaceuticals. Raphy retired from Teva in September 2024 and founded Nudelman ChemTox Consulting, where he continues to provide consulting services in the pharmaceutical impurity qualification field.

Dr. Alexander Amberg, DE

Head of In Silico Toxicology / R&D Preclinical Safety FF

Sanofi Aventis Deutschland GmbH

Alexander Amberg performed his doctoral studies at the department of toxicology and pharmacology at the University of Wuerzburg (Germany) and obtained his PhD in biochemical toxicology in 2000. In 2001, he joined the early and exploratory safety group of Sanofi, and in this position has been responsible for in silico/computational toxicology analysis globally at Sanofi. Since 2007, he has been registered as a European registered toxicologist (ERT) after getting his examination of Fachtoxikologe DGPT from the German Society of Toxicology. His major research interests are development of new in silico prediction models for different toxicity endpoints and data management of in-house data in combination with publicly available toxicity data, to support drug development in research and development. For this he is also a member of different internal expert advisory groups as well as external initiatives, like the IMI eTOX consortium (for toxicity data sharing and development of new expert systems for in silico toxicity prediction), the IMI SafeSciMET education program and others. With respect to genotoxic impurities (GTIs), he was actively involved in the preparation of the white paper for the use of in silico systems in the scope of ICH M7 and other publications regarding GTIs. Internally, he is member of the task force to support the in-house implementation of ICH M7.

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

George Johnson is an associate professor of genetic toxicology at Swansea University. He has expertise in the quantitative use of genetic toxicity data for hazard and risk assessment purposes and has an interest in high content and multiplex in-vitro test systems. He currently has active roles in the HESI-GTTC, IWGT 2022, COM and EEMGS-EXCOM, and carries out teaching, research, and consultancy at Swansea.

Dr. Andrew Teasdale, UK

Director (Former Head of Impurity Management & CMC Strategy at AstraZeneca)

AT CMC Solutions Limited 

Dr. Raphael Nudelman, IL

Consultant

Nudelman ChemTox Consulting

Dr. Alexander Amberg, DE

Head of In Silico Toxicology / R&D Preclinical Safety FF

Sanofi Aventis Deutschland GmbH

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

BROCHURE 

Request the 10th Impurities: Genotoxic, Nitrosamine, & Beyond Summit brochure and find out the latest topics and ideas that will be shared.

RECORDINGS

Request 9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit 2025 recording, brochure, and authorised presentation materials, and find out the latest topics and ideas that were shared during the event.

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What our
participants
are saying

"The #Egenotoxic Summit is a must-attend event for anyone involved in pharmaceutical impurity management. The expert insights and practical case studies have been invaluable in helping us navigate the evolving regulatory landscape."

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Elena

Quality Assurance Manager

"This summit brings together the leading minds in genotoxic impurity control. The discussions on nitrosamine risk assessment and ICH M7 compliance have directly influenced our internal strategies and improved our product safety standards."

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Mark

Senior Regulatory Affairs Specialist

"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."

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Sophia

Toxicology Lead