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Development of Central Nervous System Drugs with Abuse Potential
Session Chair(s)
Anne Tomalin, RAC
, Tpireg, A Division of Innomar-Strategies Inc., Canada
Assessment of Abuse Liability in Drug Development for Central Nervous System Active Compounds
Learning Objective : Explain what a controlled substance is including the process for drug scheduling; Describe how abuse liability is assessed during drug development; Apply knowledge of drug scheduling and FDA requirements for proactive management of a drug development project; Discuss the conduct of clinical trials for drugs with abuse potential; Describe current state of the art of abuse resistant/deterrant formulations; Explain the regulatory requirements for label claims of such formulations.
Speaker(s)
Eva M. Finney
Director, Global Project & Alliance Management, Merck & Co., Inc., United States
Assessment of Abuse Liability in Drug Development for Central Nervous System Active Compounds
Damon Smith
Chief Executive Officer, Altus Formulation Inc., Canada
Development of Abuse Resistant/Deterrant Formulations and Associated Label Claims
Ann Marie Hake, MD
Executive Director, Medical – Digital Health, Eli Lilly and Company, United States
Conducting Clinical Trials with Drugs Having Abuse Potential
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