Guidelines for Pharmacovigilance Stakeholder Communication

1) Purpose

The purpose of this SOP is to establish procedures for effective communication with stakeholders involved in pharmacovigilance activities to ensure transparency, compliance, and timely exchange of information.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for communicating with internal and external stakeholders, including regulatory authorities, healthcare professionals, patients, and marketing authorization holders.

3) Responsibilities

The Communication Officer is responsible for coordinating stakeholder communication activities. The Pharmacovigilance (PV) Manager ensures adherence to this SOP and oversees communication strategies.

4) Procedure

4.1 Identification of Stakeholders

1. Identify key stakeholders involved in pharmacovigilance activities, including regulatory authorities, healthcare providers, patients, and internal teams.
2. Assess the information needs and communication preferences of each stakeholder group.

4.2 Communication Planning

1. Develop a communication plan that outlines the objectives, key messages, target audience, channels, and frequency of communication.
2. Ensure that communication activities align with regulatory requirements and company policies.

4.3 Communication Channels

1. Utilize various communication channels such as email, newsletters, meetings, webinars, and conferences to disseminate information to stakeholders.
2. Establish secure channels for confidential or sensitive communications, especially when sharing patient-related or proprietary information.

4.4 Communication Content

1. Prepare clear and concise communication materials, including reports, updates, notifications, and educational resources, tailored to the needs of different stakeholder groups.
2. Ensure that all communications are accurate, transparent, and compliant with regulatory guidelines.

4.5 Response Management

1. Establish procedures for receiving, documenting, and responding to inquiries, feedback, and requests from stakeholders in a timely manner.
2. Assign responsibilities for responding to stakeholder queries and escalate issues as necessary to ensure timely resolution.

4.6 Crisis Communication

1. Develop protocols for managing communications during pharmacovigilance crises, such as safety alerts, product recalls, or emerging safety concerns.
2. Ensure that crisis communication plans include predefined messages, escalation procedures, and coordination with relevant stakeholders.

4.7 Documentation and Record Keeping

1. Maintain comprehensive records of all stakeholder communication activities, including planning documents, correspondence, meeting minutes, and response logs.
2. Ensure that all documentation is stored securely and is accessible only to authorized personnel.

4.8 Training and Awareness

1. Provide training to all PV personnel involved in stakeholder communication on the procedures and best practices outlined in this SOP.
2. Ensure that new employees receive training on stakeholder communication as part of their onboarding process.

4.9 Continuous Improvement

1. Regularly review and update stakeholder communication strategies and processes based on feedback, regulatory changes, and emerging best practices.
2. Implement improvements to enhance the effectiveness and efficiency of stakeholder communication activities.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Communication plans, stakeholder profiles, communication materials, response templates, training materials.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Risk Evaluation and Mitigation Strategies (REMS): Modifications and Revisions, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.

8) SOP Version

Version 1.0