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David Heal will give a presentation at the American College of Toxicology Virtual Meeting (November 12th to 19th 2020) as part of the Continuing Education Course—CE07 entitled “Understanding the Assessment of Abuse Potential: Industry and Regulatory Perspective”

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David Heal will give a presentation at the American College of Toxicology Virtual Meeting (November 12th to 19th 2020) as part of the Continuing Education Course—CE07 entitled “Understanding the Assessment of Abuse Potential: Industry and Regulatory Perspective”

The session will be chaired by Dr Reem Elbekai (Otsuka Pharmaceutical Development and Commercialization) and Dr William Brock (Brock Scientific Consulting). The other presenters are Dr Mike Klein, who is the previous Directors of the FDA’s Controlled Substance Staff and Dr Dominic Chiapperino, the current Director of CSS, and the clinical expert, Professor Ed Sellers (University of Toronto and DL Global Partners).

11:00 AM–11:05 AM            
Introduction

CE07-1     11:05 AM–11:45 AM
Pharmacology and Molecular Mechanisms of Drugs of Abuse

CE07-2     11:45 AM–12:30 PM
Role of Abuse Testing in the Development of CNS Drugs
David J. Heal, DevelRx Ltd and University of Bath.

12:30 PM–1:00 PM
Break

CE07-3     1:00 PM–1:40 PM
Conducting a Successful Human Abuse Potential Study and Integration with Other Clinical Data
Edward Sellers, University of Toronto and DL Global Partners.

CE07-4     1:40 PM–2:20 PM
Regulatory Perspective on Abuse Potential Assessment and the Drug Scheduling Process
Dominic Chiapperino, US Food and Drug Administration, Center for Drug Evaluation and Research

2:20 PM–2:30 PM
Questions and Answers

 

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