Preeminent members of the nation’s Food and Drug bar will drill you in the basics of FDA law and regulation as they help you:
  • MASTER the basics of the application and approval processes for drugs and biologics
  • COMPREHEND the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH
  • DEVELOP a practical working knowledge of clinical trials for drugs and biologics
  • APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • RECOGNIZE the pivotal role of labeling in the drug and biologics approval process
  • SEE the importance of cGMPs to the post-approval regulatory process
  • NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls