Description

FDA Boot Camp is a conference that covers topics such as:

  • The application and approval processes for drugs and biologics
  • The structure of FDA and the roles of the CDER, CBER,and CDHR
  • The complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
  • The effects of real-world evidence on the drug approval process
  • The pivotal role of labeling
  • A practical working knowledge of the clinical trials process
  • The importance of cGMPs to the post-approval regulatory process
  • The requirements for the advertising, marketing, and promotion of drugs and biologics
  • The protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

FDA Boot Camp might be held in Mar 2025.

More Details

Organizer:
American Conference Institute (ACI)
Website:

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Important

Please, check "FDA Boot Camp" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Legal
Government & Global Issues: Law & Regulations

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