Pre-Conference Workshop A: Controlled Substances Boot Camp: Introduction To The Fundamentals

Jan 29, 2018 2:00pm – 5:00pm

Ronald W. Chapman, II
Shareholder
Chapman Law Group (Troy, MI)

Dominic Chiapperino
Acting Director Controlled Substance Staff Center for Drug Evaluation and Research
Food and Drug Administration

Robert N. Nicholson
Partner
Nicholson & Eastin LLP (Fort Lauderdale, FL)

This workshop provides a basic overview of controlled substance regulations and prepares you for the more in-depth discussions that will take place throughout the main conference. This session will set the stage for the main conference by helping attendees thoroughly comprehend the structure of the DEA and FDA while walking through the evergreen and recent challenges that arise when working with controlled substances. Get the background you need to flow seamlessly into the more in-depth discussions that will take place during the main conference.   Topics include:
  • Introduction to the DEA and FDA: agency missions and organizational structures
  • History of controlled substances regulations
  • Intersection between FDA and the DEA: how to work effectively with both agencies
  • Overview of the drug scheduling process and its effects on approval
  • How to de-schedule a drug or move to a different schedule
  • Registration for a DEA number
  • Understanding abuse-deterrence, its current status, and its effect on the approval process
  • Responding to DEA enforcement actions
  • State licensing and the interplay with federal regulations
  • Advertising and promotion of controlled substances