Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Venue: DIA

Location: Horsham, Pennsylvania, United States

Event Date/Time: Aug 13, 2012 End Date/Time: Aug 15, 2012
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This is a basic- to intermediate-level overview course, intended for individuals who have at least some experience in clinical safety of biopharmaceutical products. The focus will be on pharmacovigilance of traditional medicinal products intended for human use. Topics will span investigational and marketed products as used in clinical trials, in post-marketing studies, and under conditions of actual use in real-world healthcare settings.

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 pre-marketing phase
Data collection, processing, and requirements in the post-marketing phase
Case studies and practical exercises
Active safety surveillance in the post-marketing phase
Audits and inspections
Introduction to signal detection and risk assessment
Basics of risk management in the US and EU
Principles of pharmacoepidemiology

Who Should Attend
Individuals with limited to intermediate experience in the area of clinical safety or pharmacovigilance, including those from the pharmaceutical industry, academia, and drug regulatory authorities, should attend. In addition, those with job roles in medical writing, marketing, and those who need an overview of clinical safety and may interact with members of those departments, should attend.

Learning Objectives
Participants who complete this course 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 post-marketing phase
Demonstrate an awareness of risk management principles and pharmacoepidemiology

Barton L. Cobert, MD,AHIP,FACP
BLCMD Associates, LLC, United States
William Gregory, PhD
Senior Director, Safety and Risk Management
Pfizer Inc., United States



Enterprise Drive Suite 200
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