Guidelines for Pharmacovigilance Aggregate Report Approval

1) Purpose

The purpose of this SOP is to establish procedures for the review, approval, and submission of pharmacovigilance aggregate reports to regulatory authorities.

2) Scope

This SOP applies to personnel responsible for reviewing and approving pharmacovigilance aggregate reports, including pharmacovigilance managers, medical assessors, and regulatory affairs professionals.

3) Responsibilities

The Pharmacovigilance Aggregate Report Reviewer is responsible for conducting comprehensive assessments of aggregate reports. Regulatory affairs personnel coordinate submission activities and ensure compliance with regulatory timelines.

4) Procedure

4.1 Aggregate Report Compilation

1. Compile pharmacovigilance data from various sources, including adverse event reports, clinical trials, and post-marketing surveillance studies, to generate aggregate reports.
2. Ensure accuracy, completeness, and consistency of data included in aggregate reports based on predefined reporting periods and regulatory requirements.

4.2 Report Review and Assessment

1. Review aggregate reports to verify data integrity, statistical analysis methodologies, and adherence to pharmacovigilance guidelines (e.g., ICH E2C).
2. Assess the clinical relevance and significance of safety signals, adverse event trends, and risk-benefit evaluations presented in aggregate reports.

4.3 Medical Review and Sign-off

1. Engage medical assessors and therapeutic area experts to provide clinical and medical review of aggregate report findings and conclusions.
2. Obtain medical sign-off and endorsement of aggregate reports to validate clinical interpretations and ensure accuracy of safety assessments.

4.4