Ensuring patient safety is the foundation of pharmacovigilance, and aggregate reports play a vital role in achieving this goal. These reports consolidate drug safety data over a specific period, offering a broader view of a product’s safety profile. They are essential for identifying risks, monitoring adverse events, and staying compliant with regulatory requirements worldwide.
In this blog, we’ll discuss key types of aggregate reports—PADER, PSUR, DSUR, PBRER—and their importance in pharmacovigilance.
PADER (Periodic Adverse Drug Experience Report):
PADER is a mandatory report for pharmaceutical companies in the United States. It summarizes adverse drug events at regular intervals, helping regulatory authorities track drug safety trends. With PvEdge®, organizations can automate the preparation of PADER, ensuring accuracy and timely submission to the FDA while reducing manual workload.
PSUR (Periodic Safety Update Report):
PSUR is crucial for tracking the global safety profile of a drug throughout its lifecycle. It allows companies to analyze long-term safety data and identify potential risks. PvEdge® makes it easier to compile PSURs by integrating data from multiple sources, ensuring compliance with EMA and other international regulatory bodies.
DSUR (Development Safety Update Report):
DSUR focuses on safety data during clinical trials, offering insights into emerging risks. It is essential for ensuring the safety of trial participants. These reports allow sponsors to assess new risks during development and act proactively to safeguard participants.
PBRER (Periodic Benefit-Risk Evaluation Report):
PBRER helps assess whether the benefits of a drug outweigh its risks. It consolidates global safety data and aids in making informed regulatory decisions. This report supports organizations in evaluating safety outcomes alongside clinical benefits, ensuring comprehensive drug assessment.
Aggregate reports like PADER, PSUR, DSUR, and PBRER are essential tools for ensuring patient safety and meeting regulatory requirements. They provide a comprehensive view of a drug’s safety profile, helping organizations manage risks effectively.
At Sarjen Systems Pvt Ltd, our solution PvEdge® empowers companies to streamline the preparation and submission of these reports, ensuring compliance and promoting patient safety worldwide.
