概要

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.

特集トピック

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

参加対象

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

学習目的

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

Learning objectives will be achieved using a combination of trainer presentations, trainer-led plenary discussions, and case studies.

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