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Essentials of Drug Safety

 
The Essentials of Drug Safety course gives you a good understanding of the basic principles of pharmacovigilance – the course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings, how to assess cases for seriousness, expectedness and causality, and how to report adverse events cases.

Course Content:
  • Learning Objectives for this Module
  • History of Pharmacovigilance
  • Pre-Marketed AEs
  • Post-Marketed AEs
  • Pre- and Post-marketing: Basic Differences
  • The Importance of Adverse Event Reporting
  • Pharmacovigilance Definitions
  • ICH Definition of Adverse Event
  • ICH Definition of Adverse Drug Reaction
  • Suspected Unexpected Serious Adverse Reaction
  • Sources of ADRs
  • Pharmacovigilance Process
  • Assessing Adverse Events
  • Regulatory Definition of a Serious Adverse Event
  • Severity/Intensity
  • Difficulty Assessing Relationship of AEs with Drug
  • Causality
  • Lack of Efficacy
  • Expectedness
    • Assessing Expectedness/Labeledness/Listedness
    • Labeled vs. Listed
  • General Types of Reports
    • Expedited Reporting – What to Report
    • Expedited Reporting – What not to report
  • Aggregate Reports – Common Types
  • Reporting Timeframes for ICSRs
  • Timelines for Follow-Up
  • Reporting to IRB/ECs
  • Investigator Notification
  • Minimum Criteria for Reporting
  • Minimum Data Set – Day “0”
  • Reporting Format
  • Key Data Elements for Inclusion in Expedited Reports
  • Managing Blinded Therapy Cases
  • Special cases
  • Adverse Reaction Types
  • Safety Signal Generation: Definition
  • Pharmacovigilance Process
  • Quiz on Module 1