9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit

Name: 9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit
Start: 2025-04-09 00:00:00 UTC
End: 2025-04-10 00:00:00 UTC

09 to 10 Apr '25
Munich Germany

Conference / Summit (onsite & online)
Pharmaceuticals
Genetics

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The detection and control of nitrosamines and other genotoxic impurities (GTIs) have become critical concerns, necessitating a comprehensive and rational risk assessment strategy to ensure product safety and regulatory compliance.

Welcome to #VLgenotoxic 2025, where our focus intensifies on the urgent issues surrounding N-nitrosamines. As the industry grapples with evolving regulatory frameworks, toxicological uncertainties, and the technical challenges of impurity identification, this summit serves as a vital platform for exploring these pressing issues.

Mark your calendars for the 9th Impurities: Genotoxic, Nitrosamine, & Beyond conference, taking place on April 09-10, 2025.

Key Themes & Topics

avigating the Complexities of Pharmaceutical Impurities: Trends and Challenges at the 9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit (#VLgenotoxic)

The Valsartan recall, driven by the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in widely prescribed pharmaceuticals, has been a pivotal moment for the pharmaceutical industry. This incident has underscored several critical issues:

The urgent need to investigate potential N-nitrosamine contamination and assess the associated mutagenic and carcinogenic risks to patients.
A wave of drug withdrawals, recalls, and clinical trial delays affecting medications like ranitidine, nizatidine, metformin, rifampin/rifapentine, and varenicline.
The necessity of developing a balanced risk-assessment strategy to avoid misjudging the risks related to nitrosamines in pharmaceutical products.

The Valsartan incident has revealed key gaps in current pharmaceutical practices, including:

The need for more stringent scrutiny from both the FDA and drug manufacturers concerning NMDA and NDEA impurities.
Emerging strategies and revised acceptable intake (AI) thresholds for nitrosamine impurities.
Incorporating nitrosamine formation risk assessments into pharmaceutical processes, from drug substances (DS) and drug products (DP) to drug product packaging (DPP).
The importance of collaboration among pharmaceutical experts, researchers, academia, and toxicologists to advance knowledge and methodologies that will shape future regulations for controlling N-nitrosamines and other mutagenic impurities.
Developing robust control strategies to minimize nitrosamine impurities, optimize manufacturing processes, and reduce carcinogenic risks to patients.
The complex risk analysis requires the involvement of multiple stakeholders, including API manufacturers, excipient providers, primary packaging suppliers, and drug product manufacturers.

At the #VLgenotoxic 2025 Summit, our discussions will extend beyond N-nitrosamines, focusing on:

Crucial aspects of detecting and reporting genotoxic impurities in the pharmaceutical industry.
The latest findings from ongoing investigations, addressing regulatory, toxicological, analytical, and pharmaceutical considerations related to genotoxic impurities (GTIs).
The implementation and impact of ICH M7 guidelines, offering insights into hazard identification and risk assessment processes for GTIs.
Preventing N-nitrosamine contamination in human medicines and exploring alternative strategies for initial risk evaluation and confirmatory testing of drug products and APIs.
Recent advancements and future considerations regarding various pharmaceutical impurities, including genotoxic impurities, nitrosamines, elemental impurities, extractables, and leachables.

Learning Outcomes

Attendees will benefit from keynote presentations, detailed case studies, interactive panel discussions, and Q&A sessions. Explore exhibition opportunities and forge valuable partnerships while gaining insights into advanced strategies and evolving perspectives on impurities, extractables, and leachables (E&L).

Our comprehensive program will also feature technical training and workshops focusing on:

Practical regulatory and toxicological considerations for the identification, monitoring, and control of mutagenic impurities (ICH M7).
Lessons learned and critical issues related to the quality, safety, and efficacy of drug products.
Addressing uncertainties and inconsistencies in nitrosamine safety assessments.
Updates on regulatory requirements and perspectives on nitrosamines.
The latest experiences and developments in E&L and elemental impurities (ICH Q3D).

Participants at #VLgenotoxic 2025 will receive a digital certificate of attendance.

Prerequisites & Requirements

Who Should Attend:

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

Analytical Science
Active Pharmaceutical Ingredient (API) Development
Assay Development
Biotherapeutics
Carcinogenic Impurities
Carcinogenicity
Carcinogens
Chemistry (Analytical, Organic, Medicinal, Protein)
Chromatography
Degradation Products
DNA Reactive Impurities
DNA Reactivity
Drug Design
Drug Development
Drug Discovery
Drug Safety
Drug Substance
Elemental Impurities
Extractables & Leachables
Formulation
Genetic Toxicology
Genotoxic Impurities (GTI)
Genotoxicity
Genotoxin
GMP
Good Laboratory Practice
GRAs
GTIs
Impurities
In Silico
Finished Pharmaceutical Products (FPPs)
Large Molecule
LC-MS
Mass Spectrometry
Microscopy
Mutagenic Impurities
Mutagenicity
Nanomaterials
Nanoparticles
New Modality
N-nitrosamine Drug Substance-Related Impurities (NDSRIs)
Oligonucleotide
Organic Synthesis
Particles
Peptide
Potential Genotoxic Impurities (PGTIs)
Preclinical Drug Safety
Process Chemistry
Process-Related Impurities
Product-Related Impurities
Protein
Purification
Purge Factors
Quality Assurance (QA)
Quality By Design (QbD)
Quality Control (QC)
Regulatory
R&D
Safety Assessment
Small Molecule
Spectroscopy
Total Daily Intake (TDI)
Technology Transfer
Threshold of Toxicological Concern (TTC)
Toxicology
Validation

Who Should Attend

Roles

Analysts
Chief Executive Officers
Chief Technology Officers (CTO)
Compliance & Legal Specialists
Consultants & Advisors
Directors and Heads of Department
Doctors, Surgeons & Medical Specialists
Educators & Academics
Entrepreneurs
Managers and Executive Managers
Procurement & Supply Chain Specialists
Research Scientists
Vice Presidents (VPs)

Departments

Ethics, Legal & Compliance
Health, Environment, & Sustainability
Innovation Labs
Production Manufacturing
Product & Service Development
Project Management & Quality Assurance
Research & Development
Strategy & Transformation

Webinars

9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit

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Location

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