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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Reporting and Public Viewing of Individual Case Safety Reports (ICSRs)

Step Status
Educational Content
Starts On: Thu, 6/23/22: 12:00 AM EDT
Ends On: Tue, 5/13/25: 12:00 AM EDT
Type: Enduring Material
Credits: 1
Description: The purpose of this webinar is to understand the reporting of Individual Case Safety Reports (ICSRs) to FDA and learn how to access and view the publicly available data in the FDA Adverse Event Reporting System (FAERS). This session also will focus on understanding data issues encountered in ICSRs and providing tips and methods to improve data quality.
  • Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.

  • Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: Slides