Introduction to Drug Safety

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.

The module takes an average of 4 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program (6 modules) or Drug Safety eLearning Bundle (7 modules).

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

-Previous Participant

• 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

This module is designed for professionals involved in:

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

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
• Identify reference safety information provided by the Investigator’s Brochure and post-marketing labeling
• Explain the assessment of seriousness, expectedness, and causality of adverse events