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The Quality Quotient: Rethinking PSURs for Regulatory Excellence
Rose Coley1, Andrea Rau2, Karen Doolittle3
1Clinical Safety & Pharmacovigilance, Moderna, Inc., 325 Binney Street, Cambridge, MA, 02142, USA. rose.coley@modernatx.com.
Background:
Regulatory Authorities demand high-quality safety reporting to ensure proper oversight of marketed medicinal products. The Periodic Safety Update Report (PSUR) Quality Metric was developed to evaluate, measure, and enhance the quality of PSURs submitted to Regulatory Authorities, while identifying areas for continuous improvement.
Methods:
A comprehensive method was established which included analyzing Regulatory Authority feedback, categorizing quality-related comments, and then employing a scoring system based on predefined categories.
Results:
The PSUR Quality Metric demonstrates transparency and compliance with regulatory requirements by ensuring that the Marketing Authorization Holder actively monitors, tracks, and improves the quality of safety data submitted.
Conclusion:
The PSUR Quality Metric provides a structured framework to maintain high standards of data quality, regulatory compliance, and continuous improvement in PSUR submissions. This tool fosters a culture of quality and supports regulatory excellence through systematic evaluation and actionable feedback.
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