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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 6: Aggregate Safety Analysis Plan

Session Chair(s)

James  Buchanan, PharmD

James Buchanan, PharmD

  • Drug Safety Consultant
  • Covilance LLC, United States
  • Program Safety Analysis Plan (PSAP)
  • Aggregate Safety Analysis Plan (ASAP)

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