Why Attend?

Last Year’s Agenda
Location & CLE

Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for drugs
  • New Drug Application Process (NDA)
  • Biologics and biosimilars
  • Post-approval drug safety issues
  • Advertising and promotion requirements
  • FDA’s enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Kefauver-Harris Amendments
  • Drug Price Competition and Patent Restoration Act of 1984 (Hatch-Waxman)
  • Biologics Control Act
  • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Food and Drug Administration Modernization Act (FDAMA)
  • Food and Drug Administration Act (FDAAA)
  • Biologics Price Competition and Innovation Act (BPCIA)
  • Prescription Drug User Fee Act (PDUFA)
  • Generic User Fee Amendments (GDUFA)
  • Drug Quality and Security Act (DQSA)
  • 21st Century Cures Act

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Register!

 

Industry & Firms

$1399
  • +$600 for non-members
  • +$100 after Winter 2022

Non-Profit

$999
  • +$100 for non-members
  • +$100 after Winter 2022

Government

$999
  • +$100 for non-members
  • +$100 after Winter 2022

Academic

$999
  • +$100 for non-members
  • +$100 after Winter 2022

Student

$999
  • full-time students only
  • +$100 after Winter 2022
REGISTER NOW

 

Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips.  Order your copy today and it will be shipped directly to your office.

 

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