Nitrosamine impurities continue to pose a significant challenge for pharmaceutical quality and safety. This intensive workshop, held at the Leeds Innovation Centre, is designed to provide practical, science-led approaches to nitrosamine risk assessment. As regulatory expectations from the EMA and FDA continue to evolve, staying compliant requires a deep understanding of both chemical formation and toxicology. This workshop will guide participants through the entire nitrosamine lifecycle—from identifying potential risks in synthetic routes and manufacturing processes to performing robust in silico assessments using Mirabilis.
The day is structured into three core modules. First, we examine the chemistry of nitrosation, exploring how secondary amines and nitrating agents interact under various conditions. Second, we dive into the "Lhasa Carcinogenicity Database" to understand how to derive acceptable intakes for N-nitrosamines, even when data is sparse. Finally, we move into a hands-on session where attendees will use Lhasa tools to generate regulatory-ready reports. Unlike a standard seminar, this workshop encourages active participation. Attendees are encouraged to bring anonymized case studies for group discussion under a confidentiality agreement. By the end of the session, you will have a clear framework for justifying control strategies to regulators, potentially avoiding costly and time-consuming analytical testing where the risk is shown to be negligible.
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