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 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.”
- 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
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