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6th Nitrosamines & Beyond: Genotoxic Impurities Summit 2026

🔥 15% OFF | Until October 23
Genotoxic Impurities Nitrosamines & Beyond
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Conference Overview

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 nitrosamines 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:

● Regulatory Affairs Professionals
● Analytical Scientists and Chemists
● Toxicologists and Safety Assessors
● CMC and QA/QC Experts
● Computational Toxicology Specialists
● Good Manufacturing Practice (GMP)
● Biologics and Device Developers
● Process Development Scientists
● Risk Assessment
● Nitrosamines
● Analytical Development
● Regulatory Affairs

Join our community on LinkedIn  |  Join the Nitrosamines & Genotoxic Impurities Network on LinkedIn

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.

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Speaking Companies

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Previous Events
Genotoxic Impurities Nitrosamines
5th Genotoxic Impurities Summit: Nitrosamines & Beyond 2025
December 4, 2025
Two-day virtual event focused on the latest developments, technical challenges in genotoxic impurity control. [Recording: 14 video sessions].
Expired
[•REC] - €345
Genotoxic-Impurities-Nitrosamines-Beyond
4th Genotoxic Impurities Summit: Nitrosamines & Beyond 2024
December 4, 2024
Meeting with subject matter experts to evaluate different points of view on how to solve the problems associated with mutagenic impurities. [Recording: 13 video sessions].
Expired
[•REC] - €245
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Speaker Board
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Sanghamitra Mishra
Managing Director
NexGenTox
Gemma Packer
Gemma Packer
Senior Scientist
Lhasa Limited
Ian Ashworth
Ian Ashworth
Principal Scientist
AstraZeneca
Robert A. Jolly
Robert A. Jolly
Senior Advisor
Eli Lilly and Company
Arianna Bassan
Arianna Bassan
Principal Consultant
Innovatune
Maria Chapela
Maria Chapela
Senior Principal Scientist
GSK
Jason Brown
Jason Brown
Founder
Brown Pharma Consulting
Olivier Dirat
Olivier Dirat
Senior Director – Global Regulatory Sciences
Pfizer
Crystal DSilva
Crystal DSilva
Associate Director – Preclinical Toxicology
Baxter
George Johnson
George Johnson
Consultant
GTOX Ltd
Andrew Teasdale
Andrew Teasdale
Former Head of Impurity Management & CMC Strategy
AstraZeneca
Stephanie Simon
Stephanie Simon
Associate Scientific Director
Merck Healthcare KGaA
Jan Wenzel
Jan Wenzel
Principal Scientist II
Sanofi
Raphael Nudelman
Raphael Nudelman
Chemical Toxicologist
Nudelman ChemTox Consulting
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Summit Agenda
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◆  Investigating in vivo mutation data for derivation of BMDL metrics.

◆  Using in vivo mutation BMDl in different mutation derived acceptable intake calculations.

◆  Future directions in this area…

Swansea-University
Swansea University, UK    GTOX Ltd, UK

Speakers:

◆  N-Nitroso bisoprolol as case study.

◆  Applying BMD modeling to identify a PoD.

◆  Using the relative potency (anchor) approach for calculating an Acceptable Intake (AI) limit.

◆  Considerations for human risk assessment.

Merck-Healthcare
Merck Healthcare KGaA, DE

Speakers:

◆  A holistic approach to setting acceptable intakes for NDSRIs.

◆  Other N-nitroso-compounds (o-NNOs).

Nudelman-ChemTox-Consulting
Nudelman ChemTox Consulting, IL

Speakers:

◆  Deriving substance-specific acceptable intakes beyond CPCA-based values: practical examples of when read-across supports an alternative intake and when it does not.

◆  Establishing a robust read-across justification beyond structural similarity: the importance of scientific evidence and expert judgement in supporting surrogate selection.

◆  Building a weight-of-evidence justification for the surrogate-based acceptable intake using additional evidence, including comparative potency, steric hindrance and bioavailability potential.

◆  Preparing a clear justification for regulatory submission: explaining the proposed acceptable intake and addressing uncertainties.

NexGenTox
NexGenTox, IN

Speakers:

◆  Setting limits for impurities in Development, normal and genotoxic.

◆  Predicting nitrosamine formation.

◆  Challenges in setting limits for nitrosamines.

EliLilly
Eli Lilly, USA

Speakers:

◆  Thematic Focus: General Mutagenic Impurities.

◆  Description: Using the ICH M7 framework to prove that manufacturing processes naturally eliminate impurities justifying the reduction of routine batch testing.

Pfizer
Pfizer, UK

Speakers:

◆  Default CPCA-based potency categorization often assigns nitrosamine impurities a conservative lifetime AI limit.

◆  A three-pillar in vitro alternative — hepatocyte metabolism/reactive-metabolite ID, an enhanced Ames test, and a TK6 mammalian gene mutation assay — can build a mechanistic weight-of-evidence case without in vivo data.

◆  The 3Rs-aligned framework generalizes across NDSRI-containing drug products and offers a resource-efficient and data-driven pathway to justify alternative AI limits.

Baxter-Healthcare
Baxter, BE

◆  Computational toxicology/chemistry support of Nitrosamines de-risking.

◆  In silico risk assessment of Nitrosamines using quantum chemistry to estimate the reactivity and mutagenicity of Nitrosamines.

◆  Demonstrating recent examples.

Sanofi
Sanofi, DE

Speakers:

◆  

◆  

GSK
GSK, UK

Speakers:

◆  Metabolic insights from in silico predictions for selected NDSRIs.

◆  CYP-mediated bioactivation, α-hydroxylation, and detoxification pathways.

◆  Selected examples.

Innovatune
Innovatune, IT

Speakers:

◆  This presentation will demonstrate the applicability of in silico tools and data sharing in identifying and informing risk mitigation strategies for nitrosamines.

Lhasa-Limited
Lhasa Limited, UK

Speakers:

◆  What is in scope? From a regulatory standpoint and understanding the science, which product types and possible nitrosamines are of concern?

◆  What are the unique differences in risks with these product types?

◆  Why are active nitrosamine controls more important for large molecules and synthetic biologics? What are the key components to keep your product safe?

Brown Pharma Consulting
Brown Pharma Consulting, USA

Speakers:

◆  General kinetic models of aqueous nitrous acid-based nitrosamine formation.

◆  Modelling nitrosamine formation in a solid drug products.

◆  Stability of nitrosamines.

AstraZeneca
AstraZeneca, UK

Speakers:

◆  Focus: Both Nitrosamines & General Mutagenic Impurities.

◆  Description: Managing impurity risks during site transfers, supplier changes and scale-up to ensure continuous compliance throughout the product lifecycle.

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Frequently Asked Questions
1. General Questions

Uventia Global is a leading organizer of professional international online webinars, training sessions, and summits specifically tailored for specialists in the pharmaceutical, biotechnology, and medical device industries. We focus on critical topics such as regulations, validation, quality control, and GMP standards.

Most of our events are conducted in a real-time, interactive online webinar and virtual summit format, allowing participants from anywhere in the world to engage and ask questions.

2. Registration & Participation

On the event page, in the "Register" section, select the appropriate ticket and fill out the registration form, providing your corporate details.

Yes, all registered participants who attend the event can receive an official digital certificate of participation (for professional development purposes), which can be added to their portfolio or resume.

3. Session Format, Q&A, and Interactivity

Questions are submitted via the Q&A feature; our host reads them out, and the speaker answers. You are welcome to ask multiple questions.

Yes, there will be a Q&A session after each presentation. Typically, a speaker's presentation lasts 25 minutes, followed by a 5–10 minute Q&A session.

If the allotted time for Q&A has run out and not all questions have been addressed, the speaker will answer them in writing within the Q&A section. Additionally, all questions and answers (in written form) will be available on the materials server, to which you will have access.

4. Billing & Corporate Packages

We accept corporate bank transfers via invoice, as well as secure credit/debit card and PayPal payments directly through our website.

Yes! If multiple participants from the same company register for an event, we offer attractive special corporate packages. Please contact our sales team via email or through the website form for details.

If you are unable to attend, you may transfer your registration to a colleague from your organization at no extra cost, provided you notify us in advance. Detailed refund terms are outlined in our Terms and Conditions. In the event of a cancellation on our part, we will issue a full refund.

5. Post-Event Materials & Archive

Yes, all session video recordings will be accessible on our dedicated server for registered attendees.

Session recordings remain accessible for two years, while PDF presentations are available for download indefinitely.

Yes, you can download PDF presentations to your hard drive; video recordings will also be available for download.

6. Technical Support

We use reliable online conferencing platforms (such as Zoom, MS Teams, or specialized virtual platforms). A modern web browser and a stable internet connection are all you need.

If you experience technical issues on the day of the event, please use the emergency contact details provided in the pre-webinar confirmation email or contact info@uventia.com

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Registration Tickets

15% off for 1 person, 20% off per person for 2–3 people, and 25% off per person for 4+
🔥 Discount valid until 23rd of October 2026

To receive a discount coupon, email us at info@uventia.com or submit a brochure request.

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2 Days Ticket + Recording
€595

Full access to the 2 days online event.

Recording of 2 days event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

1 Day Ticket + Recording
€415

Full access to the 1 day online event.

Recording of 1 day event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

2 Days Recording
€495

Recording of 2 days event sessions.

Digital certificate of attendance.

List of participants.

PDF presentations.

To register to the summit as a Delegate, complete the registration form. After submission, you will receive confirmation and invoice. Registration for the virtual event covers access to all online material in the Proceedings including keynotes, PDF presentations and papers, posters, and delegate list with contacts as well as video recordings of speakers' speeches.

If you need more information, please contact us at info@uventia.com

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