Tag: PSUR submission workflow
PSUR, PBRER, and DSUR Explained: Ultimate Guide to Global Pharmacovigilance Reporting
PSUR, PBRER, and DSUR Explained: Ultimate Guide to Global Pharmacovigilance Reporting Mastering PSUR, PBRER, and DSUR: Compliance-Ready Guide for Global Safety Submissions Introduction to PSUR, PBRER, and DSUR and Their Importance Periodic safety reporting is a cornerstone of pharmacovigilance, ensuring ongoing monitoring of medicines after clinical development and marketing authorization. Three main report types dominate global regulatory submissions: the Periodic Safety Update Report (PSUR), the Periodic Benefit-Risk Evaluation Report (PBRER), and the Development Safety Update Report (DSUR). These reports provide regulators with cumulative safety data, risk-benefit evaluations, and updated safety signals for both investigational and marketed products. Agencies such as…