5th Annual Genotoxic & Non-Genotoxic Impurities: Nitrosamines & Beyond Summit 2025
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5th Annual Genotoxic & Non-Genotoxic Impurities: Nitrosamines & Beyond Summit 2025

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Genotoxic Impurities Nitrosamines
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Conference Overview

Join industry leaders, regulatory experts and scientific innovators at the 5th Genotoxic and Non-Genotoxic Impurities: Nitrosamines and Beyond Summit, a premier two-day virtual event focused on the latest developments, regulatory expectations and technical challenges in impurity control.

Day 1 delves deep into the evolving landscape of nitrosamine impurities, featuring expert-led sessions on global regulatory updates, risk assessment strategies, toxicological evaluation and advanced analytical techniques. Discussions will cover nitrosamine drug substance-related impurities (NDSRIs), predictive assessments using in silico tools and the impact of formulation, manufacturing and stability on impurity formation.

Day 2 expands the focus to genotoxic and non-genotoxic impurities, highlighting computational tools for early hazard identification, common profiling pitfalls and unique challenges in biologics and medical devices. With dedicated sessions on qualification and regulatory perspectives, the summit provides a comprehensive view on managing both mutagenic and non-mutagenic impurity risks across the pharmaceutical lifecycle.

What We Will Discuss

  • Global nitrosamine regulations, risk assessment tools and control strategies.
  • In-silico models and SAR tools for predicting nitrosamine formation pathways.
  • Analytical advances for detecting low-level nitrosamines and NDSRIs in products.
  • Formulation and manufacturing factors influencing nitrosamine impurity levels.
  • Strategies for identifying and controlling genotoxic and non-genotoxic impurities.
  • Regulatory and toxicological approaches to qualify elemental and unknown impurities.

Who Is It For?

This summit is designed for professionals involved in impurity profiling, risk assessment, regulatory compliance and pharmaceutical development, including:

● Regulatory Affairs Professionals
● Analytical Scientists & Chemists
● Toxicologists & Safety Assessors
● CMC and QA/QC Experts
● Manufacturing Science & Technology
● Drug Substance
● Process Development Scientists
● Computational Toxicology
● In-Silico Modeling Specialists
● Medical Device Developers
● Biologics Developers
● Risk Assessment

This event is relevant to professionals in pharmaceutical, biotechnology, medical devices, contract manufacturing and regulatory agencies seeking to stay ahead of current impurity challenges and compliance requirements.

Agenda 5th Annual GTI: Nitrosamines & Beyond Summit 2025

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

Previous Events
Genotoxic-Impurities-Nitrosamines-Beyond
Expired
[•REC] - €495
4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024
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3rd Annual Genotoxic Impurities Nitrosamines & Beyond
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[•REC] - €345
3rd Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2023
November 30, 2023
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Speaker Board
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Lukas Jost
Lukas Jost
PhD student
Fresenius Medical Care
Jason Brown
Jason Brown
Director, Analytical Sciences
Adare Pharma Solutions
Olivier Dirat
Olivier Dirat
Senior Director – Global Regulatory Sciences
Pfizer
Crystal DSilva
Crystal DSilva
Associate Director – Preclinical Toxicology
Baxter
George Johnson
George Johnson
Associate Professor
Swansea University
Malcolm Ross
Malcolm Ross
Consultant
Generapharm
Teresa Wegesser
Teresa Wegesser
Sr. Principal Scientist
Amgen Inc.
Susanne Glowienke
Susanne Glowienke
Head Impurity Safety
Novartis Pharma AG
Mike Urquhart
Mike Urquhart
Scientific Director
GSK
Reinhard Stidl
Reinhard Stidl
Senior Toxicologist - Managing Director
Safetree Consulting e.U.
Raphael Nudelman
Raphael Nudelman
Chemical Toxicologist
Nudelman ChemTox Consulting
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Summit Agenda
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◆  Global regulatory perspectives and harmonization efforts.

◆  Updates from EMA, FDA, WHO and PMDA on nitrosamine controls.

◆  Evolving expectations for regulatory submissions and GMP alignment.

◆  Use of genetic toxicity data for assessing nitrosamines.

◆  Calculating BMD and AI using in vivo mutation data.

◆  Recent considerations from the ICH M7.

Swansea-UniversitySwansea-University
Swansea University, UK

Speakers:

◆  Overview of toxicological risk assessment of nitrosamines.

◆  Comparison between agency- and literature-published acceptable intake values.

◆  Challenges with the current state of affairs and future perspectives.

◆  Weight-of-evidence approach in setting acceptable intake limits – NDBzA as a case study.

Baxter-HealthcareBaxter-Healthcare
Baxter, BE

Speakers:

◆  Analytical challenges in Large Volume Parenterals.

◆  Method development at ppt range.

◆  Method validation in an international laboratory network.

Fresenius Medical CareFresenius Medical Care
Fresenius Medical Care, DE

Speakers:

◆  Applying reactivity testing to identify nitrosamine formation risks.

◆  Leveraging in silico and SAR tools for predictive assessment.

◆  Interpreting results to inform control strategies and mitigation plans.

◆  Identifying nitrosamine risks during formulation and scale-up.

◆  Impact of excipients, solvents and process conditions.

◆  Mitigation strategies in manufacturing to limit formation.

GenerapharmGenerapharm
Generapharm, CH

Speakers:

◆  Processes from initial risk identification through control strategy implementation.

◆  Product control vs. testing requirements.

◆  Mitigation techniques, when active change is needed.

Adare Pharma SolutionsAdare Pharma Solutions
Adare Pharma Solutions, USA

Speakers:

◆  Use of (Q)SAR tools and expert systems for early hazard identification.

◆  Regulatory expectations and applicability under ICH M7 guidelines.

◆  Integrating in-silico predictions into risk assessment workflows.

◆  Applying a risk-based approach to avoid unnecessary testing.

◆  Leveraging analytical advancements for accurate impurity detection.

◆  Profiling across drug substances, intermediates and finished products.

◆  Risk assessment frameworks specific to biologics.

◆  Handling residual solvents, linkers and crosslinking agents.

◆  Case studies in peptides, oligonucleotides and ADCs.

◆  Regulatory frameworks: ISO 10993-17 and updated guidance.

◆  Genotoxic and non-genotoxic impurity evaluation in device materials.

◆  Case studies in drug-device combinations and novel materials.

◆  Current standard approaches in toxicological risk assessment of E&L.

◆  Route to route extrapolation and read across.

◆  Update on ICH guideline Q3E on the assessment and control of E&L.

Safetree-ConsultingSafetree-Consulting
Safetree Consulting e.U., AT

Speakers:

◆  Overview of approaches for qualifying non-mutagenic impurities.

◆  Key considerations from the EMA Draft Guideline on Qualification of NMIs.

◆  Establishing acceptable limits based on safety data and exposure levels.

AmgenAmgen
Amgen, USA

Speakers:

◆  Use of (Q)SAR tools for initial impurity screening.

◆  Integration of expert review to support predictions.

◆  Role of read-across in hazard identification.

◆  Implementing updated ICH Q3D guideline requirements.

◆  Analytical techniques for detecting elemental impurities.

◆  Control strategies to manage elemental impurity levels.

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Registration Tickets

25% discount for 1 person registered, 30% discount per person if 2-3 bookings, and 30% discount per person if 4+,. The discount is valid until 25th of July 2025

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

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.

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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.

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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