Guidelines for Pharmacovigilance Medical Assessment

1) Purpose

The purpose of this SOP is to establish standardized procedures for conducting medical assessment of adverse events and other safety data in pharmacovigilance.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the medical assessment process, including medical assessors, safety physicians, and pharmacovigilance managers.

3) Responsibilities

The Medical Assessment Team is responsible for evaluating the clinical significance of adverse events, assessing their impact on the benefit-risk profile, and providing medical insights into safety issues. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Receipt and Initial Assessment of Adverse Events

1. Receive adverse event reports from healthcare professionals, consumers, and clinical trials.
2. Conduct an initial assessment to verify the completeness and accuracy of the reported information.
3. Review the medical and clinical aspects of the adverse event, including relevant medical history and concomitant medications.

4.2 Medical Assessment and Clinical Review

1. Assign cases to qualified medical assessors for detailed clinical review and assessment.
2. Evaluate the clinical significance and severity of the adverse event based on medical literature and established guidelines.
3. Assess the impact of the adverse event on the benefit-risk profile of the medicinal product.

4.3 Causality Assessment

1. Use standardized causality assessment tools (e.g., WHO-UMC criteria) to determine the likelihood of the adverse event being related to the medicinal product.
2. Document the causality assessment findings and rationale for the determination.
3. Include any medical opinions or recommendations based on the causality assessment.

4.4 Collaboration and Consultation

1. Collaborate with other members of the pharmacovigilance team, including safety scientists and regulatory affairs, for comprehensive review and decision-making.
2. Consult with medical experts or advisory committees as needed to address complex medical issues or uncertainties.
3. Document all consultations and their outcomes in the adverse event case file.

4.5 Risk Management Recommendations

1. Based on the medical assessment findings, provide recommendations for risk minimization measures, product labeling updates, or additional safety studies.
2. Communicate risk management recommendations to the PV Manager and relevant stakeholders.
3. Implement approved risk management measures and monitor their effectiveness.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all medical assessments, clinical reviews, and causality determinations.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.7 Quality Control

1. Conduct regular quality control checks on the medical assessment process to ensure accuracy and consistency.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.8 Training and Communication

1. Provide training to medical assessors on adverse event assessment, clinical review techniques, and causality determination.
2. Communicate updates to medical assessment procedures and guidelines to ensure consistency in practices.
3. Report any issues or challenges encountered during the medical assessment process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Adverse event case reports, medical assessment findings, causality assessment reports.

7) Reference, if any

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

8) SOP Version

Version 1.0