Overview

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.

Featured topics

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

Who should attend?

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

Learning objectives

After the completion of this virtual live training course, participants will be able to:

Understand the structure, sections, and annexes of the PSMF
Understand the importance of the PSMF in the Pharmacovigilance system of a pharmaceutical company
Understand 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
Understand the regulatory expectations for this important document, common inspection findings and gaps
Understand the quality performance indicators, timely submission of ICSRs, PSURs, and safety variations

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

TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
Mac OS X: 10.5, 10.6, 10.7
Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirement

Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
Mac OS X: Intel processor, At least 512 MB RAM
Linux: At least 512 MB RAM

Display

800x600 pixel resolution or greater (1024x768 pixels recommended)

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