Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Overview

This basic to intermediate-level course is based on the popular Premarketing Clinical Safety and Postmarketing Drug Safety and Pharmacovigilance Training Courses and focuses on pharmacovigilance of traditional medicinal products intended for human use. Topics will span investigational and marketed products in clinical trials, postmarketing studies, and under conditions of actual use in real-world health care settings. Late breaking regulatory changes, pertaining to the EU will be presented. Attendees will gain a detailed understanding of safety and pharmacovigilance obligations and best practices.

Course Level: Intermediate

What you will learn

Legal basis for safety reporting including a historical perspective
Basic definitions and tools
Evaluation of seriousness, expectedness, and causality
Safety reporting requirements in the premarketing phase
Data collection, processing, and requirements in the postmarketing phase
Case studies and practical exercises
Active safety surveillance in the postmarketing phase
Audits and inspections
Introduction to signal detection and risk assessment
Basics of risk management in the US and EU
Principles of pharmacoepidemiology

Learning objectives

At the conclusion of this activity, participants should be able to:

Identify the history, principles, and regulatory framework for clinical drug safety
Discuss the basic definitions of terms used in day-to-day pharmacovigilance work
Recognize basic international regulatory requirements for safety surveillance, as well as those requirements specific for the US and EU
Describe the criteria and elements of expedited and periodic reporting of drug safety from first in human studies through the postmarketing phase
Demonstrate an awareness of risk management principles and pharmacoepidemiology

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