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DESIGNED FOR EXPERTS BY EXPERTS


EUDRAVIGILANCE AND EVMPD




OBJECTIVES

This course aims to give you a knowledge and understanding of EMA’s EudraVigilance.
Specific highlights: 
  • EudraVigilance nature, purpose and features
  • Eudravigilance reporting modules (post-authorisation and clinical trials)
  • Recent changes to Eudravigilance pharmacovigilance system (XML formats and impacts to safety database set-ups, Access policy considerations, Signal detection requirements, Medical Literature Monitoring)
  • Electronic ICSR preparation
  • Medical product information
  • What is the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and what does it provide
  • Importance of XEVMPD data in the revised Eudravigilance system
  • Applied rules and methods to populate the dictionary : electronic reporting through the ESTRI gateway

 

Eudravigilance, EMA, pharmacovigilance system, EU pharmacovigilance, EU regulations, SUSAR, safety database, adverse reactions, ADR, ICSR, MAH, reporting, post-authorisation, clinical trials, xEVMPD, EVMPD, Article 57, Signal detection, ESTRI

 

LEARNING OUTCOMES

At the end of this course, you will be able to:

  • know what EudraVigilance is, the purpose of it and what it supports

  • know to the reporting modules that EudraVigilance provides

  • know changes to Eudravigilance

    • XML formats and impacts to safety database set-ups

    • Access policy considerations

    • Signal detection requirements

    • Medical Literature Monitoring

  • prepare for Electronic reporting

  • know where to go to for further information

 

90 minutes
Online based learning
English language
Certificate of Achievement
150 €
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AUTHORS

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Dr. Sherael Webley

University of Hertfordshire

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Subhash Mistry

Manager (Applications Development and Support)
GlaxoSmithKline Research and Development Ltd




COMPANIES OFFER

Short courses can be included in a training package for your team!


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