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Advanced Signal Management - Detection, Evaluation, and Decision-Making

This course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies.

Session 7: Post-Marketing Signal Detection (Continued)

Session Chair(s)

James  Buchanan, PharmD

James Buchanan, PharmD

  • Drug Safety Consultant
  • Covilance LLC, United States
  • Future directions in data mining
  • Data sources
  • Evaluating disproportionality outputs
  • Confounding and bias
  • Alternative increased frequency methods

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