National Costume: Take advantage of this opportunity to boost your proficiency in Drug Safety and Pharmacovigilance

Tuesday, June 6, 2023

Take advantage of this opportunity to boost your proficiency in Drug Safety and Pharmacovigilance

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