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
Meet the presenters
- Dr Joel Bercu, DABT, Executive Director, Toxicology at Gilead Sciences
Dr Joel Bercu is a toxicologist with over 18 years of experience in public health and pharmaceutical safety assessment. Joel has extensive experience applying (Q)SAR approaches to support ICH M7 compliance and plays an active role in advancing risk assessment methodologies across industry and regulatory science. He has contributed to the development of international guidance, including chairing the Risk Assessment sub-section for ICH M7 and supporting ongoing work on its addendum. - Dr Ben Thornton, Scientist at Lhasa Limited, Scientific Consultant at Consult Lhasa
Dr Ben Thornton specialises in computational toxicology, with a particular focus on nitrosamine impurities and their assessment using approaches such as the Carcinogenic Potency Categorisation Approach (CPCA). He supports organisations in applying in silico methodologies to complex safety challenges, including the qualification of impurities and alignment with regulatory guidance. His work centres on enabling confident, science-led decision-making through the integration of predictive tools, supporting data, and expert review. Through both his role at Lhasa Limited and his work with Consult Lhasa, Ben collaborates with industry scientists to apply practical, transparent approaches to chemical safety assessment.