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 Quality Assurance Checks

1. Conduct quality assurance checks to verify accuracy of data coding, consistency of report formatting, and compliance with internal standards and regulatory guidelines.
2. Document findings and observations from quality assurance reviews, and address any identified discrepancies or areas for improvement.

4.5 Report Approval and Authorization

1. Approve finalized aggregate reports based on review outcomes, medical assessments, and regulatory compliance.
2. Obtain necessary approvals and authorizations from pharmacovigilance management and regulatory affairs personnel prior to report submission to regulatory authorities.

4.6 Submission and Compliance

1. Coordinate submission logistics and timelines with regulatory affairs team to ensure timely and compliant delivery of aggregate reports to regulatory authorities.
2. Monitor regulatory updates and requirements related to aggregate reporting obligations to ensure ongoing compliance and adherence to submission deadlines.

4.7 Archival and Documentation

1. Maintain records of approved aggregate reports, including version control, submission dates, and regulatory correspondence.
2. Archive aggregate report documentation in accordance with internal archiving procedures and regulatory retention requirements.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICH – International Conference on Harmonisation

6) Documents, if any

Aggregate report templates, review checklist, medical sign-off forms, submission logs.

7) Reference, if any

ICH E2C(R2) – Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, FDA Guidance for Industry – Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.

8) SOP Version

Version 1.0