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This training course will review approaches to the implementation of signal detection and data mining 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, which can also be augmented by the application of sophisticated data mining algorithms.
Topics discussed will include signal assessment, use of signal triage algorithms, compliance with FDA guidance as specified in “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” March 2005, and the timing and frequency of signal detection, triage, and data mining runs.
Course Level: Beginner

What you will learn

  • Why signal detection is needed
  • Regulatory requirements
  • Approaches to signal detection
  • Good Pharmacovigilance practices
  • Data mining fundamentals
  • Introduction to the Bayesian Confidence Propagation Neural Network (BCPNN)
  • Proportional Reporting Ratio (PRR)
  • Multi-item Gamma Poisson Shrinker (MGPS)
  • Managing signals
  • Signal detection strengthening and management
  • Signal detection process and operation
  • Risk management basics in the US and the EU

Who should attend?

Professionals who work in:

  • Clinical safety and pharmacovigilance
  • Pharmacoepidemiology
  • Regulatory affairs

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Define signal detection and differentiate the stages of a signal management system
  • Describe the regulations and guidance documents driving the practice of signal detection in the US and EU
  • Discuss various methods of qualitative and quantitative signal detection and data mining
  • Recognize how signal management systems can be organized and implemented