Nitrosamines remain one of the most complex and evolving challenges in pharmaceutical development, requiring collaboration across toxicology, CMC, and regulatory functions. As global guidance continues to develop, organisations are working to align their safety assessment strategies with emerging scientific approaches and regulatory expectations.
Recent recommendations from authorities including the US FDA, Health Canada, and the EMA highlight the use of structure-based assessments, such as the carcinogenic potency categorisation approach (CPCA), to support nitrosamine qualification.
In this webinar, we explore how these approaches can be applied in practice. We will demonstrate how CPCA, alongside in silico predictions and curated data sources, can be used to support scientifically justified nitrosamine qualification and enable confident safety assessment decisions.
What you will learn
- How the nitrosamine landscape is evolving and how guidance is shaping qualification strategies
- How to apply CPCA to support nitrosamine qualification in line with current recommendations
- How in silico tools, including (Q)SAR Derek Nexus and Sarah Nexus, and databases such as LCDB Plus and Vitic, support CPCA-based assessments
- Key considerations when assessing nitrosamine potency as part of qualification
- Insights from a real-world case study demonstrating nitrosamine qualification in practice
- Expert perspectives on current challenges and emerging best practices through a live panel discussion