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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 10: Signal Management System

Session Chair(s)

James  Buchanan, PharmD

James Buchanan, PharmD

  • Drug Safety Consultant
  • Covilance LLC, United States
  • GVP Module IX processes
  • Quality requirements
  • Signal detection in EudraVigilance

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