Guidelines for Expedited Pharmacovigilance Reporting

1) Purpose

The purpose of this SOP is to establish standardized procedures for expedited reporting of serious adverse events (SAEs) to regulatory authorities to ensure timely communication and compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the reporting of serious adverse events, including safety specialists, data entry operators, and managers.

3) Responsibilities

The Reporting Team is responsible for preparing and submitting expedited reports. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Identification of Reportable Events

1. Review case reports to identify serious adverse events (SAEs) that meet expedited reporting criteria.
2. Determine the regulatory reporting timelines based on the seriousness and expectedness of the event.
3. Document the identified reportable events and the rationale for expedited reporting.

4.2 Preparation of Expedited Reports

1. Access the pharmacovigilance database and log in using authorized credentials.
2. Open a new report form for the identified SAE or update an existing report as required.
3. Enter the patient information, including age, gender, and relevant medical history.
4. Document the adverse event details, including onset date, symptoms, and severity.
5. Include relevant test results, medical assessments, and concomitant medications.
6. Ensure the causality assessment and seriousness classification are accurately recorded.
7. Review the report for accuracy and completeness before finalizing it.

4.3 Submission of Expedited Reports

1. Submit the finalized report to the relevant regulatory authority within the required timeframe (e.g., 7, 15, or 30 days).
2. Use the appropriate submission method (e.g., electronic submission, fax, or postal mail) as specified by the regulatory authority.
3. Confirm receipt of the report by the regulatory authority and document the submission details.

4.4 Quality Control

1. Conduct regular quality control checks on expedited 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.

4.5 Documentation and Record Keeping

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

4.6 Training and Communication

1. Communicate expedited reporting 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 expedited reporting process to the PV Manager.

5) Abbreviations, if any

SAE – Serious Adverse Event
PV – Pharmacovigilance

6) Documents, if any

Case reports, expedited report forms, submission confirmations, quality control reports.

7) Reference, if any

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

8) SOP Version

Version 1.0