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Virtual

Nov 14, 2022 9:00 AM - Nov 14, 2022 5:00 PM

(Central Europe Standard Time)

DIA/MEB Excellence in Pharmacovigilance. Module 1: Post-Marketing

GVP Modules VI and VII

Overview

Module 1: Post-Marketing corresponds to GVP Modules VI and VII and will cover individual and periodic adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase with illustrations based on case studies as practical examples.

 

Featured topics

  • PRAC: Present and Future of Pharmacovigilance
  • Expedited Reporting Requirements in the Post-Authorisation Phase
  • Reporting Requirements in Special Situations in the Post-Authorisation Phase
  • Preparation of Aggregate Reports
    • PSUR
    • DSUR

 

Who should attend?

Professionals with experience in safety related activities of the drug development process and/or those with a need of a holistic overview about all PV related regulatory requirements will benefit most, such as:

  • Pharmacovigilance Officers, Managers, Specialists, Experts, or Coordinators
  • Regulatory Compliance, Quality or Safety departments Heads, Directors or Managers

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 Assessor
    MEB, Netherlands

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