Guidelines for Conducting Pharmacovigilance Risk Assessments

1) Purpose

The purpose of this SOP is to define the process for conducting pharmacovigilance risk assessments to identify, evaluate, and mitigate potential risks associated with medicinal products.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in risk assessment activities, including the identification, analysis, and management of risks related to drug safety.

3) Responsibilities

The Risk Assessment Team is responsible for carrying out risk assessments. The Pharmacovigilance (PV) Manager oversees the process and ensures that risk assessments are conducted in compliance with regulatory requirements and internal policies.

4) Procedure

4.1 Risk Identification

1. Gather data from various sources, including clinical trials, spontaneous reports, literature, and safety databases.
2. Identify potential risks associated with the medicinal product, considering both known and unknown safety concerns.
3. Document identified risks in the risk assessment log.

4.2 Risk Analysis

1. Analyze the likelihood and severity of each identified risk using quantitative and qualitative methods.
2. Assess the potential impact of the risk on patient safety and public health.
3. Prioritize risks based on their likelihood and impact, categorizing them as high, medium, or low risk.

4.3 Risk Evaluation

1. Evaluate the need for risk mitigation measures based on the analysis.
2. Review the current risk management strategies and determine their effectiveness.
3. Decide on additional measures needed to manage and mitigate the identified risks.

4.4 Risk Mitigation and Control

1. Develop risk mitigation plans for high and medium priority risks, detailing specific actions to reduce or eliminate the risk.
2. Implement the risk mitigation measures according to the developed plans.
3. Monitor the effectiveness of the mitigation measures and make adjustments as necessary.

4.5 Documentation and Reporting

1. Maintain detailed records of all risk assessment activities, including risk identification, analysis, evaluation, and mitigation plans.
2. Prepare risk assessment reports for internal review and regulatory submission, if required.
3. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.6 Communication

1. Communicate significant risks and mitigation measures to relevant internal and external stakeholders, including regulatory authorities.
2. Conduct regular risk assessment review meetings with the PV team and other relevant departments.
3. Provide training and updates on risk assessment procedures to all relevant staff.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Risk assessment logs, analysis reports, mitigation plans, communication logs.

7) Reference, if any

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

8) SOP Version

Version 1.0