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Joint DIA/MEB “Excellence in Pharmacovigilance” Module 3: Quality Management System

In Module 3, key elements will be provided for the establishment of a quality system in Pharmacovigilance including aspects of the applicable GVP modules the preparation for and the conduct of audits and inspections.


Overview

Module 3 of the Joint DIA/MEB “Excellence in Pharmacovigilance” covers establishment of a Quality Management System in Pharmacovigilance. It includes aspects of the applicable GVP modules, as well as preparation and conduct of audits and inspections. This module also addresses risk-based assessments, document management and PV agreements.



 

Featured topics

  • Pharmacovigilance System Master File (PSMF)
  • Audits and Inspections in Pharmacovigilance – Regulatory Perspective
  • Audits and Inspections in Pharmacovigilance – Industry Perspective
  • ”Risk based” Activities, Documentation and Pharmacovigilance Agreements
  • Role of the Qualified Person Responsible for PV (QPPV)

 

Who should attend?

This module is aimed at individuals from the pharmaceutical industry, academia, and regulatory authorities with experience in the clinical safety/pharmacovigilance area.

Level: Intermediate.

 


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)

 

Program Committee

  • Wendy  Huisman, PharmD
    Wendy Huisman, PharmD Director
    Vigifit, Netherlands
  • Fakhredin Sayed Tabatabaei, MD, PhD
    Fakhredin Sayed Tabatabaei, MD, PhD Senior Pharmacovigilance Assessor
    Medicines Evaluation Board, Netherlands
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