OVERVIEW

3rd Annual Genotoxic Impurities Summit: Beyond Nitrosamines is organized by Business Conference Facilitation (BCF) and will be held from Oct 01 - 02, 2025 at Eurostar Hotel Berlin, Berlin, Berlin, Germany.

Description:
Focusing on critical topics such as nitrosamines control, ICH M7 updates, DNA-reactive impurities, and advanced genotoxic risk assessment strategies, this summit is the ideal platform for professionals aiming to stay ahead in impurity management and enhance pharmaceutical safety standards.

Key Points:

Technological Advancements: Exploration of innovative techniques for identifying, monitoring, and controlling genotoxic impurities
Risk Assessment Advancement: Progression in risk assessment practices and guidance for impurity qualification
Regulatory Navigation: Understanding CMC regulations and industry expectations for genotoxic impurities
Comprehensive Control: Assessment, testing, and control of impurities across pharmaceutical products, drug substances, and excipients
Gap Identification: Addressing potential gaps impacting the control of mutagenic impurities
Compliance Maintenance: Critical factors for adhering to ICH M7 and Q3D guidelines.
Carcinogenic Risk Mitigation: Effective control strategies for DNA-reactive N-nitrosamine impurities.
Strategy Alignment: Navigating uncertainties and aligning strategies for nitrosamine management