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.
“This module was extremely helpful in providing knowledge about crucial information around key pharmacovigilance processes.”
- Drug Safety: The Basics
- 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
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