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Introduction to Signal Detection and Data Mining

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Overview 

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.

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 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 within their company

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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