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Joint DIA/MEB “Excellence in Pharmacovigilance” Module 5: Signal Management

Module 5 covers signal management in the EU.


Overview

Module 5 of the Joint DIA/MEB "Excellence in Pharmacoviglance" virtual live training course covers Signal Management and Detection in the EU.

New safety signals may emerge at any time following product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. Signal Management is, therefore, one of the crucial “routine” Pharmacovigilance activities.

Approaches to Signal Management using qualitative and quantitative methods will be illustrated in a workshop with examples as well as general considerations on signal management in the EEA.



 

Featured topics

  • Introduction to Signal Detection in the European Union – Regulatory Perspective
  • Signal Management in the EU – Industry Perspective

 

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