Introduction to Drug Safety and Pharmacovigilance Workshop

May 16, 2022 | 9:00AM - 5:00PM

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.

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Course Outline

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