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Introduction to Drug Safety Workshop

October 2 @ 8:00 am - 5:00 pm

Introduction to Drug Safety Workshop

Register online

Dates Available

December 4, 2020

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $685.00 + HST

Location

Online

Live interactive and instructor led

Overview

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.

Featured Topics

  • Drug Safety: The Basics
  • Terminology
  • Tracking a Case from Start to Finish
  • Assessing Cases
  • Reference Safety Information: The Investigator Brochure and Postmarketing Labeling

Learning Objectives

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
  • Clinical research
  • Regulatory affairs
  • Medical writing
  • Marketing

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.

Details

Date:
October 2
Time:
8:00 am - 5:00 pm
Event Category:

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