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Basics of Signal Detection and Pharmacoepidemiology


Overview

This module is part of the DIA Drug Safety eLearning Program. The Basics of Signal Detection and Pharmacoepidemiology module provides an introduction to signal detection in pharmacovigilance.  The module provides information about safety signal basics, safety databases, data mining and the mathematics of drug safety, principles of pharmacoepidemiology, and signaling regulations.


“Excellent information and well-organized. The course lays out signal detection information in an easy to follow format with clear writing that is nice for the novice Pharmacovigilance user, while still providing good information for a seasoned professional like myself.”

- Previous Participant

Featured topics

  • Safety signal basics
  • Safety databases
  • Data mining and the mathematics of drug safety
  • Principles of Pharmacoepidemiology
  • Signaling regulations

Who should attend?

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Postmarketing activities
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

Learning objectives

Upon completion of this course, participants should be able to:

  • Define a safety signal and list the activities in signal management
  • List different safety databases and the information each contains
  • Explain the mathematics of drug safety, data mining, and its role in signal detection
  • Define pharmacoepidemiology and explain its role in drug safety management
  • Explain signaling regulations in the US and EU, and CIOMS VIII principles for signal detection

This module takes an average of 3.5 hours to complete.

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