Nitrosamine, Genotoxic and Elemental Impurities LIVE will provide practical regulatory, toxicology, analytical considerations, open discussion, Q&A, and interaction on:

efficient mutagenic and elemental impurities, incl. Nitrosamines, identification, monitoring, and control,
critical issues and best practices on quality, safety, and efficacy of drug products and substances,
expectations on regulatory /> Join online conference/webinar, networking & virtual exhibition, learn and exchange a recent practical experience on the subject.

About the Nitrosamine, Genotoxic and Elemental Impurities Live

Nitrosamines form a large group of genotoxic chemical carcinogens, which are probable human carcinogens. The recent N-Nitrosamine experiences have highlighted the importance of a risk assessment strategy for potential nitrosamines in the pharmaceutical product.

Based on the recent critical issues and lessons learned from the Sartans incidents, companies need to establish appropriate control strategies to prevent or minimize the presence of nitrosamine impurities, improve manufacturing processes.

Nitrosamine, Genotoxic and Elemental Impurities LIVE on 22 April 2021 will be hosted by the leading subject matter experts, providing an opportunity to

• Exchange worldwide practice, and acquire additional clarifications related to the implementation of ICH M7
• Share critical considerations and recommendations for assessment and control of DNA reactive (mutagenic) impurities
• Address the challenges related to extractables and leachables, elemental impurities ( ICH Q3D )
• Address uncertainties and misalignment in Nitrosamine safety assessment

Join #VLgenotoxic presentation, networking sessions + virtual expo, and obtain the recent practical regulatory, toxicology, analytical experience via:

• learning, discussion, extending networking, asking questions, getting answers, initiation subject-specific roundtable discussion;
• participation in the interactive discussion on the latest strategies and perspectives in the respective field;
• Engagement in comprehensive, informative presentations / technical training related to:
• efficient mutagenic and elemental impurities, incl. Nitrosamines, identification, monitoring, and control,
• critical issues and best practices on quality, safety, and efficacy of drug products and substances,
• expectations on regulatory

A digital certificate of attendance will be available for participants of Nitrosamine, Genotoxic and Elemental Impurities LIVE in April 2021.

Who Should Attend

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

• Analytical Science
• Active Pharmaceutical Ingredient ( API )Development
• Assay Development
• Carcinogens
• Chemistry (Analytical, Organic, Medicinal, Protein)
• Drug Safety
• Elemental Impurities
• Extractables & Leachables (E&L)
• Genetic Toxicology
• Genotoxic Impurities (GTIs)
• Genotoxicity
• Good Manufacturing Practices (GMP)
• Good Laboratory Practice (GLP)
• Impurities
• In Silico
• Microscopy
• Mutagenic Impurities
• Mutagenicity
• N-Nitrosamine
• Organic Synthesis
• Permitted Daily Exposure (PDEs)
• Purification
• Quality Assurance
• Quality by Design (QbD)
• Quality Control
• Regulatory
• Toxicology
• Validation
• Quantitative Structure-Activity Relationships ((Q)SAR)