Guidelines for Writing Pharmacovigilance Aggregate Reports

1) Purpose

The purpose of this SOP is to establish standardized procedures for writing pharmacovigilance aggregate reports to ensure accurate, consistent, and comprehensive documentation of safety data.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the writing and review of aggregate reports, including safety specialists, data analysts, and managers.

3) Responsibilities

The Aggregate Reporting Team is responsible for compiling and writing aggregate reports. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Aggregate Report Writing

1. Identify the types of aggregate reports required (e.g., PSURs, DSURs, PADERs).
2. Gather all relevant data, including individual case safety reports (ICSRs), periodic safety update reports (PSURs), and other safety data.
3. Organize and prioritize the data to be included in the aggregate report.

4.2 Drafting the Aggregate Report

1. Access the pharmacovigilance database and other relevant sources of information.
2. Compile and summarize the safety data, including individual case safety reports (ICSRs), aggregate data, and significant findings.
3. Analyze the data to identify any new safety signals or changes in the benefit-risk profile of the product.
4. Document the methodology and results of the data analysis in the aggregate report.
5. Include sections on the product’s safety profile, benefit-risk assessment, and any necessary risk minimization measures.
6. Review the draft report for accuracy, completeness, and clarity before finalizing it.

4.3 Review and Approval

1. Submit the draft aggregate report to the PV Manager and other relevant stakeholders for review.
2. Incorporate any feedback or revisions from the review process into the final report.
3. Obtain formal approval of the final aggregate report from the PV Manager or authorized signatory.

4.4 Submission of the Aggregate Report

1. Submit the finalized aggregate report to the relevant regulatory authorities within the required timeframe.
2. Use the appropriate submission method (e.g., electronic submission, postal mail) as specified by the regulatory authority.
3. Confirm receipt of the report by the regulatory authority and document the submission details.

4.5 Quality Control

1. Conduct regular quality control checks on aggregate reports to ensure accuracy and compliance with regulatory requirements.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all aggregate reports, including initial drafts, revisions, and final submissions.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.
3. Keep a log of all aggregate reports submitted and their corresponding regulatory timelines.

4.7 Training and Communication

1. Communicate aggregate report writing procedures and updates to all relevant staff members.
2. Provide training on reporting tools and techniques to ensure consistency and quality.
3. Report any issues or challenges encountered during the aggregate report writing process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance
PSUR – Periodic Safety Update Report
DSUR – Development Safety Update Report
PADER – Periodic Adverse Drug Experience Report

6) Documents, if any

Case reports, periodic safety update reports, data analysis reports, draft and final aggregate reports, quality control reports.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VII.

8) SOP Version

Version 1.0