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Product Testing, Evaluation & Post-Market Issues


Course Details

This course can only be taken as part of the Certificate in Biomedical Regulatory Affairs.

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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
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