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Live Webinar: To Control or be Controlled – Navigating the abuse potential evaluation of CNS-active drugs for EU and US submissions
With Dr Andy Mead and Dr Beatrice Setnik
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.

Mar 11, 2021 04:00 PM in London

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Speakers

Dr Andy Mead
Head of Drug Abuse and Substance Use Disorders @Sygnature Discovery
Andy has over 25 years' experience in the science of drug abuse and addiction across academia, biotech and pharma, and possesses a strong publication record in developing the science of drug abuse and substance use disorders. His experience includes activities in the non-clinical abuse potential field, as well as regulatory strategy and broader drug safety leadership. Andy has worked across all stages of the drug discovery and development pipeline, including leadership positions at Merck, Pfizer and AstraZeneca, before joining Sygnature Discovery in 2020 as Head of Drug Abuse and Substance Use Disorders.
Dr Beatrice Setnik
Chief Scientific Officer, Scientific & Regulatory Affairs @Altasciences
Beatrice has been working in the area of clinical drug development and abuse potential (AP) assessment since 2005. She is currently the Chief Scientific Officer at Altasciences and an Adjunct Professor at the University of Toronto (Department of Pharmacology and Toxicology). Beatrice earned her doctorate degree in Pharmacology and the Collaborative Program in Neuroscience from the University of Toronto in 2005. She has published numerous research articles in internationally recognized peer-reviewed journals and is a recognized expert in the field of human abuse and physical dependence potential evaluation.