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 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
- 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