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Introduction to Drug Safety


Overview

This module provides a foundation of knowledge required to work day-to-day in clinical safety and pharmacovigilance. It provides information on the legal basis for safety reporting, including a historical perspective; basic definitions and tools; the mechanics of drug safety and pharmacovigilance; reference safety information provided by the Investigator’s Brochure and postmarketing labeling; and evaluation of seriousness, expectedness, and causality of adverse events.


“This module was extremely helpful in providing knowledge about crucial information around key pharmacovigilance processes.”

-Previous Participant


Featured topics

  • Drug Safety: The Basics
  • Terminology
  • A Company Safety Unit
  • Tracking a Case from Start to Finish
  • Assessing Cases
  • Reference Safety Information: The Investigator's Brochure and Postmarketing Labeling

Who should attend?

This module is designed for professionals involved in:

  • Clinical safety and pharmacovigilance
  • Clinical research
  • Regulatory affairs
  • Medical writing
  • Marketing

Learning objectives

Upon completion of this module, learners should be able to:

  • Discuss the history, principles, and regulatory framework for clinical drug safety
  • Define terms used in day-to-day pharmacovigilance work
  • Describe a typical company drug safety unit and the path of a case from start to finish
  • Explain reference safety information provided by the Investigator's Brochure and postmarketing labeling
  • Explain the assessment of seriousness, expectedness, and causality of adverse events

This module takes an average of 4 hours to complete.

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