National Costume: Enhance your skills in Drug Safety and Pharmacovigilance

Tuesday, May 30, 2023

Enhance your skills in Drug Safety and Pharmacovigilance – seize this opportunity!

Greetings!

The Workshop 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.

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Course Outline

The following specific topics will be addressed in detail:

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