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The Clinical Impact of Adverse Event Reporting
Learning Objectives
Upon completion of The Clinical Impact of Adverse Event Reporting, health professionals should
be
able to:
- Identify underlying principles of postmarketing surveillance
- Understand reporting requirements (health professionals, manufacturers, user facilities)
regarding regulated medical product safety
- Discuss basic limitations/strengths of data derived from postmarketing surveillance
- List examples of FDA regulatory actions that have been based on postmarketing
surveillance
- Describe how FDA disseminates information regarding medical product safety
- Understand how a national postmarketing surveillance program impacts clinical
practice
Stephen A. Goldman, M.D.
Associate Director for Medicine, MEDWATCH
Office of the Commissioner, FDA
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