Adverse Event Reporting
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Table of Contents
Table of Contents
This course provides educational information and does not replace professional medical advice, diagnosis, treatment, or clinical judgment.
Every year, millions of adverse events go unreported, compromising patient safety and regulatory compliance. This course transforms you into a skilled reporter who can systematically identify, document, and escalate adverse events across healthcare settings.
What You Will Learn
- 1 Understand the fundamentals of adverse event reporting and patient safety culture
- 2 Interpret global regulatory frameworks including FDA, EMA, and ICH guidelines
- 3 Classify adverse events by severity, seriousness, and expectedness using standardized terminology
- 4 Implement pharmacovigilance principles for drug safety monitoring and signal detection
- 5 Apply medical device adverse event reporting requirements under FDA and EU MDR
- 6 Conduct post-market surveillance and signal detection using quantitative methods
- 7 Perform root cause analysis and design corrective and preventive actions (CAPA)
- 8 Manage adverse event reporting in clinical trials in compliance with Good Clinical Practice
- 9 Navigate global harmonization standards including E2B and electronic submission formats
- 10 Address ethical issues, transparency, and effective communication in adverse event reporting
What's Included
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Adverse Event Reporting