To Control or be Controlled: Navigating the abuse potential evaluation of CNS-active drugs for EU and US submissions

With Dr Andy Mead (Sygnature Discovery) and Dr Beatrice Setnik (Altasciences)

An introduction to the abuse potential requirements from both non-clinical and clinical perspectives, highlighting how scientific and regulatory aspects feed into the design of a successful abuse potential package, and how the two disciplines come together to provide a cohesive and comprehensive assessment. With reference to regulatory frameworks in both the EU and the US, we will discuss key aspects of the abuse potential package and highlight important design considerations.