Guidelines for Conducting Pharmacovigilance Benefit-Risk Assessment

1) Purpose

The purpose of this SOP is to establish standardized procedures for conducting benefit-risk assessments to evaluate the safety and efficacy of medicinal products.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the benefit-risk assessment process, including safety specialists, data analysts, and managers.

3) Responsibilities

The Benefit-Risk Assessment Team is responsible for conducting the assessments. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Benefit-Risk Assessment

1. Identify the scope and objectives of the benefit-risk assessment.
2. Gather all relevant data, including clinical trial results, post-marketing surveillance data, and literature reviews.
3. Ensure all data is accurate, complete, and up-to-date before beginning the assessment.

4.2 Data Analysis

1. Apply statistical methods to analyze the benefit and risk data.
2. Evaluate the efficacy and safety of the medicinal product by comparing the benefits and risks.
3. Document the methodology and results of the analysis in a detailed report.

4.3 Interpretation of Results

1. Interpret the findings from the data analysis to determine the overall benefit-risk profile of the product.
2. Assess the clinical significance of the benefits and risks identified.
3. Document the interpretation and conclusions in the assessment report.

4.4 Review and Approval

1. Submit the benefit-risk assessment 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 assessment report from the PV Manager or authorized signatory.

4.5 Communication of Findings

1. Communicate the findings of the benefit-risk assessment to relevant internal and external stakeholders.
2. Provide recommendations for any necessary actions, such as updates to the risk management plan or label changes.
3. Ensure timely communication of any urgent safety concerns to regulatory authorities and healthcare professionals.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all data used in the benefit-risk assessment, including raw data, cleaned datasets, and assessment reports.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.7 Training and Communication

1. Communicate benefit-risk assessment procedures and updates to all relevant staff members.
2. Provide training on data analysis tools and techniques to ensure consistency and quality.
3. Report any issues or challenges encountered during the benefit-risk assessment process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Clinical trial data, post-marketing surveillance data, literature reviews, raw and cleaned datasets, assessment reports.

7) Reference, if any

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

8) SOP Version

Version 1.0