FDA Boot Camp

Topics

• 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