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Session Chair(s)
Anne Tomalin, RAC
Tpireg, A Division of Innomar-Strategies Inc., Canada
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)
Assessment of Abuse Liability in Drug Development for Central Nervous System Active Compounds
Eva M. Finney
Merck & Co., Inc., United States
Director, Global Project & Alliance Management
Development of Abuse Resistant/Deterrant Formulations and Associated Label Claims
Damon Smith
Altus Formulation Inc., Canada
Chief Executive Officer
Conducting Clinical Trials with Drugs Having Abuse Potential
Ann Marie Hake, MD
Eli Lilly and Company, United States
Executive Director, Medical – Digital Health
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