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Management and Reporting of ADR


Eu2P Short Course: Management and Reporting of ADR

OBJECTIVES

The purpose of this course is to give you

  • Knowledge and expertise of the classification of adverse reactions
  • Awareness of why having a knowledge of adverse drug reactions is central to pharmacovigilance
  • Understanding of the monitoring and evaluation of safety in clinical trials
  • Understanding of spontaneous reporting of ADRs and its strengths and weaknesses

Safety Signal, ADR Classification, Spontaneous Reporting, Clinical Trials, Safety issues

 

LEARNING OUTCOMES

This course will enable you to

  • Understand what safety issues need to be monitored and the appropriate methods and tools to use

  • Understand what safety data needs to be reported and when and how this should be done

  • Gain knowledge of spontaneous reporting, its advantages and limitations, factors influencing reporting and the reasons for under reporting

  • Understand the necessary content of such reports,their follow-up, assessment and uses

 

240 minutes
Online based learning
English language
Certificate of Achievement
400 €
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AUTHORS

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Dr. Sherael Webley

University of Hertfordshire

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John Talbot

AstraZeneca AB




COMPANIES OFFER

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


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