Guidelines for Developing Pharmacovigilance Risk Management Plans

1) Purpose

The purpose of this SOP is to describe the process for developing and maintaining Pharmacovigilance Risk Management Plans (RMPs) to identify, evaluate, and mitigate risks associated with medicinal products throughout their lifecycle.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the creation, implementation, and updating of RMPs.

3) Responsibilities

The Risk Management Team is responsible for developing and maintaining RMPs. The Pharmacovigilance (PV) Manager ensures the RMPs are compliant with regulatory requirements and are regularly reviewed and updated.

4) Procedure

4.1 Development of Risk Management Plans

1. Gather information on the medicinal product, including its safety profile, clinical trial data, and post-marketing surveillance data.
2. Identify potential risks associated with the product and classify them based on their severity and likelihood.
3. Define risk minimization measures and additional pharmacovigilance activities required to manage identified risks.
4. Draft the RMP, including sections on the product overview, safety specifications, pharmacovigilance plan, and risk minimization measures.
5. Review the draft RMP with relevant stakeholders, including clinical, regulatory, and medical affairs teams.
6. Finalize the RMP and obtain approval from the PV Manager and other designated authorities.

4.2 Implementation of Risk Management Plans

1. Distribute the approved RMP to all relevant departments and ensure understanding and compliance with the plan.
2. Implement the risk minimization measures and additional pharmacovigilance activities outlined in the RMP.
3. Monitor the effectiveness of risk minimization measures through regular reviews and data analysis.

4.3 Updating Risk Management Plans

1. Regularly review the RMP to ensure it remains current and relevant, particularly when new safety information becomes available.
2. Update the RMP to reflect changes in the safety profile of the product, new regulatory requirements, or the introduction of new risk minimization measures.
3. Submit updated RMPs to regulatory authorities as required and distribute the updated plan to all relevant departments.

4.4 Documentation and Record Keeping

1. Maintain detailed records of all versions of the RMP, including drafts, approvals, and updates.
2. Store RMPs and related documentation securely and ensure they are easily accessible for audits and inspections.
3. Keep a log of all changes made to the RMP and the reasons for these changes.

4.5 Communication

1. Communicate the key elements of the RMP and any updates to all relevant internal and external stakeholders, including regulatory authorities.
2. Conduct training sessions to ensure staff are aware of their responsibilities under the RMP.
3. Provide regular updates on the status and effectiveness of the RMP to senior management and other stakeholders.

5) Abbreviations, if any

PV – Pharmacovigilance
RMP – Risk Management Plan

6) Documents, if any

Risk Management Plans, review records, approval documents, change logs.

7) Reference, if any

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

8) SOP Version

Version 1.0