Course Overview

This course provides a clear, structured, and practical understanding of the Pharmacovigilance System Master File (PSMF). Designed for Pharmacovigilance professionals, QPPVs, Regulatory Affairs teams, and Quality leaders, it explains the purpose, structure, regulatory expectations, and operational management of the PSMF.

Through step-by-step guidance, you will learn how to build, maintain, review, and defend a compliant PSMF during inspections, ensuring alignment with global regulatory requirements and best industry practices.

What You Will Learn

1. The regulatory foundation and purpose of the PSMF
2. The three main parts and seven core sections of the PSMF
3. The role and responsibilities of the QPPV within the PSMF framework
4. The nine key annexes and how they support compliance
5. Governance, version control, and maintenance best practices
6. Common inspection findings and how to ensure inspection readiness
7. Practical strategies to transform the PSMF from a static document into a living compliance tool