SUSAR Reporting & Expedited Timelines: Definitions, Global Workflows, and Inspection-Ready Controls
SUSAR Reporting & Expedited Timelines: Definitions, Global Workflows, and Inspection-Ready Controls Serious, Unexpected, and Suspected: Mastering SUSAR Reporting and the Global Expedited Clock What Triggers a SUSAR—and Who Must Receive It SUSARs—Suspected Unexpected Serious Adverse Reactions—sit at the heart of expedited pharmacovigilance. A SUSAR is a serious adverse reaction (i.e., an AE judged to have…