Introduction to Drug Law and Regulation

Location: 
Hybrid (Washington, DC and Virtual)
Event Date: 
Tuesday, November 9, 2021 to Wednesday, November 10, 2021

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 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

Learn more and register here

Media Contacts

Tim Haynes
Senior Director of Communications 
 

Without continued support for health research, many of the most promising young scientists, their ideas and a myriad of potentially life-changing scientific breakthroughs will vanish into oblivion.
Paul Marinec, PhD; University of California San Francisco