Risk Assessment Strategies

The panel examines how risk assessment strategies are evolving to keep pace with the growing scientific understanding of nitrosamine potency. The discussion covers the tools and approaches available for characterizing compounds where classification is uncertain or contested, the role of in vitro and in vivo genotoxicity data in supporting acceptable intake derivation, and how structural activity relationships and computational approaches are increasingly shaping the field. The panelists consider what a robust control strategy looks like for compounds falling into higher potency categories, and how that strategy is best communicated to regulators. The importance of published, peer-reviewed data in building regulatory confidence is a recurring theme throughout.

Moderated by Joseph Lackey, Technical Manager at LGC Standards, the discussion brings together Jason Brown, Principal Consultant at Brown Pharma Consulting Ltd, Maria Kristina Parr, a professor in pharmaceutical chemistry from the Freie Universität Berlin, Jörg Schlingemann, Director, Principal Expert Quality Control Systems at Merck Healthcare KGaA, and George Johnson, an associate professor at Swansea University.