Aggregate Reports
Explore all topics, guides, and frameworks related to Aggregate Reports.
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2- How to Write Aggregate Safety Reports Aggregate safety reporting is the disciplined interpretation of cumulative evidence over time. This article explains the common reasoning process used across PBRERs, PSURs, DSURs and other periodic reports, while showing why each report type must still be written to its own regulatory objective, population and reference information. Read Article →
- Estimating Patient Exposure in Pharmacovigilance Patient exposure provides the denominator needed to interpret aggregate safety data, but post-authorisation exposure is usually estimated rather than directly observed. This article explains how exposure should be estimated and reported in PBRERs and DSURs, how to choose among patient counts, patient-time, prescriptions, sales and DDD-based measures, and how to document assumptions and avoid treating spontaneous-reporting rates as incidence. Read Article →