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

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.