ACI Summit on Controlled Substances: Controlled Substances Bootcamp

Webinar (ET)

Delia A. Deschaine, Member of the Firm, will co-present "Controlled Substances Bootcamp: An Introduction to Key Agencies, Regulation, and Scheduling," a pre-conference workshop at the 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement, hosted by the American Conference Institute.

This bootcamp will provide an outline for the evolving regulations and compliance requirements for controlled substances to protect your company from unwanted investigations. Leading industry stakeholders will cover the ins and outs of the challenges that arise when working with controlled substances.

Topics to be discussed include:

  • An introduction to the DEA and FDA: agency missions and organizational structures relative to controlled substance regulation
  • Understanding the intersection between FDA and the DEA jurisdiction over controlled substances
  • Understanding the controlled substances scheduling process
  • Understanding abuse-deterrence, its current status, and its effect on the FDA approval process
  • Working effectively with the DEA and FDA
  • The interplay of state licensing and federal regulations related to the discovery, development and marketing of controlled substances
  • Responding to DEA enforcement actions

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