Understanding the Transition: PSUR vs PBRER

In the world of aggregate safety reporting, the comparison of PSUR vs PBRER is a vital topic for any MAH. While the Periodic Safety Update Report (PSUR) was the traditional standard, the Periodic Benefit-Risk Evaluation Report (PBRER) has now become the international norm under ICH E2C (R2) guidelines.

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Key Differences: PSUR vs PBRER

• Scope: The PSUR focuses primarily on safety findings, whereas the PBRER provides a more holistic view by incorporating “benefit” data to assess the overall risk-benefit balance.

• Format: The PBRER is designed to be a single, harmonized document that satisfies the EMA, US FDA, and other global agencies simultaneously.

• Reporting: Understanding PSUR vs PBRER is essential for meeting the different submission timelines required for Regulatory approvals in various regions.

• Watch the Youtube video for more details: https://www.youtube.com/channel/UCIPtQVEKyXNRutg7fpnL8Mw

[Image comparing PSUR and PBRER reporting requirements and formats]

Expert Advisory for Aggregate Reporting

Inaccuracies in PSUR or PBRER reports are a major source of pharmacovigilance audit findings. Properly structured reports ensure compliance with GVP modules and support product lifecycle management. Expertise in these reports improves inspection readiness and regulatory confidence.

Navigating the complexities of PSUR vs PBRER drafting can be a challenge for growing pharmaceutical firms. Inconsistencies in these reports are a major source of Pharmacovigilance Audit Findings. Our Advisory Services ensure that your aggregate reports are not only compliant with GVP modules but also strategically written to support your product’s market longevity.