In this episode of Cognitio, Tim Boyle speaks with Dr Natalie Anderson about the evolving regulatory landscape for non-animal models in pharmaceutical development.

We explore global reforms at the US FDA and European Medicines Agency, the application of the Three Rs, and how Australia’s TGA is responding to advances in organoids, organ-on-chip technologies and in silico modelling. The discussion covers regulatory acceptance pathways, policy shifts, funding challenges and what this means for sponsors and regulatory professionals.

A must-listen for those working in regulatory affairs, nonclinical development and health policy as science and regulation continue to evolve.