The FDA Boot Camp covers regulatory frameworks, approval processes, and compliance requirements for drugs and biologics.
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
