Pharmacovigilance System Master File: How to Prepare and Maintain

The Pharmacovigilance System Master File (PSMF) is the key document describing the company’s pharmacovigilance system. The PSMF is supporting and documenting the company compliance with the requirements laid down in the EU legislation and is the first document requested by a Competent Authority in preparation of a pharmacovigilance inspection.

The entire course is in line with the guidelines on EU Good Pharmacovigilance Practices (GVP): Module II – Pharmacovigilance System Master File (rev. 2), Commission Implementing Regulation (EU) No. 520/2012, and relevant EMA guidelines.

This course will take approximately 5.5 hours to complete.

This course will also be offered as a virtual live training course on 2-3 November 2023, 13:00-17:00 CEST. Register Now!

• GVP Module II- Pharmacovigilance Master File (Rev. 2) guidance
• Creation, maintenance, and management of the PSMF
• Practical exercises
• The PSMF as a quality document
• Regulatory expectations for the PSMF

This on-demand course is designed for professionals working in:

• Pharmacovigilance (including EU QPPVs)
• Drug safety and risk management
• Pharmacovigilance consultancies and service providers
• Quality and compliance

Upon completion of this module, learners should be able to:

• Identify the structure, sections, and annexes of the PSMF
• Recognize the importance of the PSMF in the Pharmacovigilance system of a pharmaceutical company 
• Evaluate the interaction between Regulatory Affairs, Pharmacovigilance, and other departments with regards to the maintenance of the PSMF
• Apply essential concepts and principles of the (GVP): Module II – Pharmacovigilance System Master File (Rev. 2)
• Recognize how to prepare and manage a sample PSMF document
• Assess the regulatory expectations for this important document, common inspection findings and gaps
• List quality performance indicators for monitoring timely submissions of ICSRs, PSURs and safety variations