Adverse Event Reporting
Pharmacovigilance activity is commonly associated with adverse event reporting which consumes a significant amount of resources for drug regulatory authorities in pharmaceutical industries. Adverse event reporting involves the data entering, case assessment, documentation, receipt and triage. This AE involves the spontaneous reports from the drug regulatory authorities. AE plays a key role in assessing the risk-benefit profile of a given drug. Adverse event leads to spontaneous reporting, clinical reporting and periodic reporting.
- Coding of adverse events
- Seriousness determination
- Expedited reporting
- Clinical trial reporting
- Spontaneous reporting
- Aggregate reporting
- Other reporting methods
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