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Signaling and Risk Management

 This module will review approaches to the implementation of signal detection as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US. Many simple techniques can be applied to the generation and review of potential signals.

Topics discussed will include signal assessment, use of signal triage algorithms, compliance with FDA and EMA guidance as specified in FDA’s “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment” and GVP Module IX, and the timing and frequency of signal detection, triage, and data mining runs.

Course Content:

  • Need for Signal Detection
  • The Cost of Failure
  • Signaling Overview
  • Regulatory Requirements
  • Signal Detection Objectives
  • Incidence, Numerator, Denominator
  • Need for the Prepared Mind
  • Signal Detection Hierarchy
  • Approach to Signal Detection
  • Signaling Examples:
    • Source Data from PSUR
    • Sector Maps
    • Analysis by MedDRA System Organ Class
    • Analysis by MedDRA Preferred Term
    • Analysis by Age Range
    • Analysis by Sex
    • Analysis by Country
    • Analysis by Concomitant Medications
  • Conclusion
  • What is Data Mining?
  • Data Mining Methods
  • Bayesian Methodology (Used by WHO)
  • MGPS Methodology (Used by FDA)
  • PRR – Proportional Reporting Ratio
  • Quiz on Module 4