Table of Contents
Faculty
The Need for Postmarketing Surveillance
Premarketing Human Clinical Studies
Postmarketing Experience
By Hospitals
Reporting Required By Law or Regulation
TABLE 3. Adverse Event (AE) Reporting Requirements for Pharmaceuticals
Limitations
Adverse Event Recognition
Underreporting
Biases
Estimation of Population Exposure
Report Quality
Strengths
Generation of Hypotheses and Signals
Clinician Contribution
Dissemination of Safety-Related Information
Clinical Synopses:
References
Self Assessment Questions
Application for Continuing Education Credit