Introduction to Drug Safety
The Introduction to Drug Safety eLearning module provides a foundation of knowledge required to work day-to-day in clinical safety and pharmacovigilance. This 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 post-marketing labeling; and evaluation of seriousness, expectedness, and causality.
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.”
- Basics of drug safety
- A company safety unit
- Tracking a case from start to finish
- Assessing cases
- Reference safety information: The Investigator's Brochure and post-marketing 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:
- Recognize the history, principles, and regulatory framework for clinical drug safety
- Define terms used in day-to-day pharmacovigilance work
- Identify a typical company drug safety unit and the path of a case from start to finish
- List reference safety information provided by the Investigator’s Brochure and post-marketing labeling
- Determine the assessment of seriousness, expectedness, and causality of adverse events