About this document
Aggregate Reporting in Pharmacovigilance by Anurag Bhardwaj is a document available to read on EtoBox.
This document contains answers to questions about aggregate reporting principles and periodic safety reports. It defines key terms like PSUR, PBRER, DSUR and summarizes their purposes and requirements. Differences between PADER and PBRER are outlined, such as content, format and frequency of submission to regulators. Common inspection findings for PSURs are also listed, such as poor quality reports and failure to assess new safety signals.
- Author
- Anurag Bhardwaj
- Language
- EN