Guidelines for Pharmacovigilance Crisis Management

1) Purpose

The purpose of this SOP is to establish procedures for managing crises related to pharmacovigilance activities, ensuring timely and effective response to adverse events or safety signals that may pose significant risks to public health.

2) Scope

This SOP applies to all pharmacovigilance personnel, including managers, regulatory affairs specialists, and crisis management teams involved in responding to pharmacovigilance-related crises.

3) Responsibilities

The Crisis Management Team (CMT) is responsible for coordinating and executing crisis management activities. The Pharmacovigilance (PV) Manager oversees the crisis management process to ensure compliance with regulatory requirements and internal policies.

4) Procedure

4.1 Crisis Identification

1. Monitor pharmacovigilance data, adverse event reports, and safety signals continuously to identify potential crises.
2. Assess the severity and potential impact of identified safety issues.
3. Determine if the situation requires activation of the Crisis Management Team (CMT).

4.2 Activation of Crisis Management Team

1. Notify senior management and relevant stakeholders of the potential crisis.
2. Form the CMT, including representatives from pharmacovigilance, regulatory affairs, quality assurance, and communications.
3. Develop an initial crisis management plan outlining roles, responsibilities, and immediate actions.

4.3 Communication and Notification

1. Prepare and issue crisis communication materials to regulatory authorities, healthcare providers, and other stakeholders.
2. Ensure clear, consistent, and timely communication throughout the crisis management process.
3. Utilize multiple communication channels (e.g., email, phone, web) to reach all affected parties.

4.4 Investigation and Analysis

1. Conduct a thorough investigation to determine the root cause of the crisis.
2. Collect and analyze relevant data, including adverse event reports, clinical trial data, and manufacturing records.
3. Document findings and develop a comprehensive crisis report.

4.5 Risk Mitigation and Response

1. Implement immediate risk mitigation measures to protect public health, such as product recalls, market withdrawals, or safety communications.
2. Coordinate with regulatory authorities to ensure compliance with regulatory requirements and guidance.
3. Develop and implement corrective and preventive actions (CAPAs) based on the investigation findings.

4.6 Post-Crisis Review and Documentation

1. Conduct a post-crisis review to evaluate the effectiveness of the crisis management process and identify areas for improvement.
2. Document all crisis management activities, communications, and decisions for audit and inspection purposes.
3. Update relevant SOPs, processes, and training materials based on lessons learned from the crisis.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, CMT – Crisis Management Team, CAPA – Corrective and Preventive Actions

6) Documents, if any

Crisis management plans, communication materials, investigation reports, crisis reports, CAPA records.

7) Reference, if any

FDA Guidance for Industry – Crisis Management, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module IX – Signal Management.

8) SOP Version

Version 1.0