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 Investigators Brochure and postmarketing labeling; and evaluation of seriousness, expectedness, and causality.
Drug Safety: The Basics
Tracking a Case from Start to Finish
Reference Safety Information: The Investigator Brochure and Postmarketing Labeling
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
Who Should Attend
Professionals working in the area of:
Clinical safety & pharmacovigilance
Certificate of Attendance and Course Material
All participants will receive a certificate of attendance upon completion of the course.
The participants will be receiving specially prepared course manual.