Perspectiva general

This virtual live training course covers essential concepts and guidance about the Pharmacovigilance System Master File (PSMF).

This key document describes the company’s pharmacovigilance system, supporting, and documenting its 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.

Participants benefit from hands-on expertise on best practices shared by trainer with extensive experience regarding PSMF including the EU-QPPV perspective.
Ample time is set aside for Q&A and interactive discussions.

Participant Testimonials

A well-informed training session with good audience participation. Appreciated the MHRA providing clear guidance. – Sara Santosh Expedith – PV Risk Specialist, Novo Nordisk, United Kingdom

Temas destacados

- GVP Module II – Pharmacovigilance System Master File (rev. 2) guidance
- Creation, maintenance, and management of the PSMF
- Practical exercise on drafting a PSMF
- The PSMF as a quality document
- Regulatory expectations for the PSMF, including UK PSMF
- Practical exercise on PSMF after an inspection

¿Quiénes deben asistir?

This virtual live training course is designed for professionals working in:
- Pharmacovigilance (including EU QPPVs)
- Drug Safety and Risk Management
- Pharmacovigilance Consultancies and Service Providers
- Quality and Compliance

Objetivos de aprendizaje

After the completion of this virtual live training course, participants will 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 the essential concepts and principles of the GVP Module II – Pharmacovigilance System Master File (rev. 2)
- Prepare and manage this document in their own organisation
- Discuss 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

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Pharmacovigilance System Master File

Perspectiva general

Participant Testimonials

Temas destacados

¿Quiénes deben asistir?

Objetivos de aprendizaje

Digital Learning Catalog

Be informed and stay engaged.