Adverse Event Reporting
/ˈædvɜrs iˈvɛnt rɪˈpɔrtɪŋ/
Definitions
- (n.) The process by which organizations, particularly in healthcare and pharmaceuticals, collect, document, and submit information about harmful or unintended effects of medical products or interventions to regulatory authorities.
The pharmaceutical company established a robust adverse event reporting system to comply with FDA regulations.
Forms
- adverse event reporting
Related terms
See also
Commentary
This term is pivotal in regulatory law concerning patient safety and product accountability; precision in defining reporting timelines and content is crucial for compliance.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.