Drug Safety and Pharmacovigilance 101
Live interactive and instructor led
Overview
The Introduction to Drug Safety module provides the basics of pharmacovigilance, its regulation throughout all stages of the drug life cycle, and the foundation knowledge required to work day-to-day in clinical safety and the pharmacovigilance industry.
The module includes the historical overview of drug safety legislation, from the beginning to the current international standards; basic definitions and tools of adverse events and adverse drug reactions recording, assessment and reporting, as well as pharmacological mechanics of drug safety. The second part of the module provides the basic skills of pharmacovigilance documentation management, including safety reports, reference safety information, and post-marketing labeling preparation and handling.
Featured Topics
- Drug Safety and Pharmacovigilance: The Basics and History
- Terminology, Definitions
- Adverse drug reactions: severity and seriousness grading, causality assessment, and reporting
- International standards of drug safety surveillance (ICH guidelines and US standards).
- Drug safety reports: Individual Case Safety Reports and Expedited Reporting
Learning Objectives
Upon completion of this course, participants should be able to:
- Discuss the history, principles, and regulatory environment of drug safety
- Define terms used in day-to-day pharmacovigilance work
- Explain the assessment of seriousness, expectedness, and causality of adverse events
- Explain pharmacovigilance methodology and documentation
- How to perform drug safety reports
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.
