Guidelines for Pharmacovigilance Adjudication Committee

1) Purpose

The purpose of this SOP is to define the roles, responsibilities, and procedures for the Pharmacovigilance Adjudication Committee in assessing and adjudicating individual case safety reports (ICSRs) in pharmacovigilance.

2) Scope

This SOP applies to members of the Pharmacovigilance Adjudication Committee within the organization.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing the operations of the Adjudication Committee. Committee members are responsible for adhering to this SOP.

4) Procedure

4.1 Committee Establishment and Membership

1. Establish the Pharmacovigilance Adjudication Committee with defined membership comprising pharmacovigilance experts, medical assessors, and other relevant stakeholders.
2. Define roles and responsibilities of committee members, including chairperson, rapporteur, and members participating in case assessment and adjudication.

4.2 Adjudication Process

1. Receive individual case safety reports (ICSRs) for adjudication from pharmacovigilance operations, medical review teams, or regulatory authorities.
2. Conduct comprehensive review and assessment of ICSRs to determine causality, seriousness, and regulatory reporting criteria.

4.3 Case Review and Assessment

1. Evaluate clinical data, patient medical history, concomitant medications, and relevant laboratory findings to assess the relationship between adverse events and suspect products.
2. Apply standardized criteria and assessment tools (e.g., WHO-UMC causality assessment scale) to determine the likelihood of the product’s contribution to the adverse event.

4.4 Adjudication Decision

1. Reach consensus among committee members regarding the adjudication decision for each ICSR, considering available evidence and expert opinions.
2. Document adjudication decisions, rationale, and supporting evidence in the pharmacovigilance database or case management system.

4.5 Communication and Reporting

1. Communicate adjudication outcomes to relevant stakeholders, including regulatory authorities, marketing authorization holders, and clinical investigators.
2. Provide recommendations for further actions, such as product labeling updates, risk management strategies, or additional safety studies.

4.6 Committee Meetings and Documentation

1. Schedule regular Pharmacovigilance Adjudication Committee meetings to review complex cases, discuss challenging adjudication decisions, and ensure consistency in assessment practices.
2. Maintain accurate records of committee meetings, including agendas, minutes, decisions, and action items.

4.7 Training and Education

1. Provide training to committee members on adjudication principles, pharmacovigilance guidelines, and regulatory expectations related to case assessment and causality determination.
2. Ensure that committee members are proficient in applying standardized assessment tools and interpreting clinical data to support informed decision-making.

4.8 Continuous Improvement

1. Regularly review Pharmacovigilance Adjudication Committee procedures and workflows based on feedback, regulatory changes, and quality assurance findings.
2. Implement enhancements to optimize committee effectiveness, streamline adjudication processes, and improve patient safety outcomes.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICSR – Individual Case Safety Report

6) Documents, if any

Adjudication guidelines, committee meeting minutes, communication templates, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VIII – Post-Authorization Safety Studies (PASS).

8) SOP Version

Version 1.0