About this Course
This course focuses on post-marketing requirements, reporting and enforcement actions, with an emphasis on inspection preparation (internal and by regulators), conduct and follow-up actions. We’ll explore post-marketing surveillance and studies, as well as the reimbursement and economics of pharmacology. As a final class project, you’ll apply the knowledge gained in the course to design a regulatory strategy for a product.
What You'll Learn
- Warning letters
- Consent decrees and injunctions
- Civil and criminal penalties
- Adverse event reporting
- Corrections, removal and recalls and product labeling issues