This module is part of the DIA Drug Safety eLearning Program. The Introduction to Drug Safety module provides a foundation of knowledge required to work day-to-day in clinical safety and pharmacovigilance.
The module 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.
- Drug Safety: The Basics
- A “Typical” Company Safety Unit
- Tracking a Case from Start to Finish
- Assessing Cases
- Reference Safety Information: The Investigator Brochure and Postmarketing Labeling
Who should attend?
Professionals working in the area of:
- Clinical safety & pharmacovigilance
- Clinical research
- Regulatory affairs
- Medical writing
Upon completion of this course, participants 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 Brochure and postmarketing labeling
- Explain the assessment of seriousness, expectedness, and causality of adverse events