Adverse Event Reporting Compliance:The Key to Safe Drug Development / Subject Safety 2014

  • 23 Apr 2014
  • Webinar

Description

Topics
  • How to know what an Adverse Event is and when to report it or them
  • The definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more
  • Understanding laboratory AEs and the "Reference Range" concept
  • Knowing the AE types and likelihood of finding "rare" events
  • Reporting of Adverse Events - when and to whom and the use of AE Terminology systems
  • Common Mistakes in AE / SAE Reporting
  • How to record Adverse Events and assess causality - the algorithm
Who should Attend

Investigators and their staff with responsibilities in the regulatory / legal and ethical considerations from pharmaceutical product (Drug or device) research involving human subjects.

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Important

Please, check "Adverse Event Reporting Compliance:The Key to Safe Drug Development / Subject Safety" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Pharma

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