FDA Boot Camp Boston

Topics

• The complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
• The core competencies of the application and approval processes for drugs and biologics
• The pivotal role of labeling
• A practical working knowledge of clinical trial process
• The importance of cGMPs to the post-approval regulatory process
• The requirements for advertising, marketing, and promotion of drugs and biologics
• The protocols of adverse events monitoring, signal detection, product withdrawals, and recalls