9th Impurities: Genotoxic, Nitrosamine, & Beyond conference - Kongress / Konferenz von Vonlanthen Group s.r.o

Welcome to #VLgenotoxic 2025, where our focus intensifies on the urgent issues surrounding N-nitrosamines. Yet, our mission extends far beyond this; we will thoroughly examine the complexities involved in detecting, reporting, and managing a wide range of GTIs. 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.

The recent surge in nitrosamine-related recalls and ongoing regulatory changes highlight the critical need for updated strategies and technologies. We will delve into the latest investigations, dissect the regulatory landscape, and evaluate new advancements in toxicology and analytical science. This summit is not just about addressing current challenges but also about anticipating future developments in the management of impurities in pharmaceuticals.

We are excited to introduce our esteemed speakers for the 9th Impurities: Genotoxic & Nitrosamine Beyond Summit, representing the forefront of pharmaceutical research and development. This exceptional lineup includes:

• Dr. Andrew Teasdale, UKSenior Principal Scientist / Head of Impurity Management & CMC Strategy, AstraZeneca

• Dr. Raphael Nudelman, ILSenior Director of Impurity Expert, R&D Operations, Teva Pharmaceutical Industries Ltd.

• Dr. Lutz Mueller, CHChair, Translational Safety Committee, Pharma Research and Early Development (pRED), Hoffmann-La Roche

• Dr. Rok Grahek, SLDepartment Head, SDC Slovenia, Lek d.d., Sandoz

• Dr. Carla Landolfi, ITEuropean Registered Toxicologist (ERT), CEO - Toxicology Risk Assessor, ToxHub

• Dr. Mark Harrison, UKAssociate Principal Scientist - Trace EWG, AstraZeneca

• Dr. Mayur Mitra, USDistinguished Scientist, Genentech

• Dr. Marko Trampuž, SLScientist, Early Development, SDC Slovenia, Lek d.d., Sandoz

• Dr. George Johnson, UKAssociate Professor, Institute of Life Science at Swansea University

Key Practical Learning Points:

• Essential strategies for ensuring compliance with ICH M7 and Q3D guidelines
• Effective management of DNA-reactive N-nitrosamine impurities to reduce carcinogenic risks
• Addressing uncertainties, resolving discrepancies, and leveraging insights on nitrosamine-related challenges
• Investigating innovative methods and technologies for identifying, monitoring, and controlling genotoxic impurities 
• Enhancing risk assessments and reviewing guidelines for the safe qualification of impurities
• Identifying and addressing potential gaps in the detection and control of mutagenic impurities.
• Navigating CMC regulations concerning genotoxic impurities, avoiding common pitfalls, and understanding industry standards
• Comprehensive evaluation, testing, and control of impurities in pharmaceutical products, drug substances, APIs, and excipients
• In-depth analysis of extractables and leachables (E&L) to assess genotoxicity and ensure thorough safety evaluations
• Latest updates, future trends, and expert insights into analytical techniques, regulatory expectations, and toxicological science

Who Should Attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising 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 (QSAR)

9th Impurities: Genotoxic, Nitrosamine, & Beyond conference

April 09-10, 2025  |  Munich, Germany & Online (CEST)

The Delegate Pass include: 

• In person attendance for 2 days of the conference 
• Access to all speakers' presentations
• Networking sessions with all speakers and participants
• Refreshments & coffee breaks
• Lunch at the venue for both conference days
• Business dinner to polish the cooperation and networking
• After-event documentation package
• On-line & Off-line support from our team

On-line attendance available with the Webinar category