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

Module 1 will cover individual and periodic adverse reaction reporting requirements.


Overview

Module 1 of the Joint DIA/MEB "Excellence in Pharmacovigilance" virtual live training course 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

  • Keynote by PRAC: Present and Future of Pharmacovigilance
  • Expedited Reporting Requirements in the Post-Authorisation Phase
  • Reporting Requirements in Special Situations in the Post-Authorisation Phase
  • Clinical Evaluation of Adverse Drug Reactions
  • Preparation of Periodic Safety Update Reports (PSURs)

 

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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Registration Questions

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+41 61 225 51 51


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+41 79 333 29 76