Practical Guide for Pharmacovigilance: Clinical Trials and Post-Marketing

Venue: Novotel Berlin-Mitte

Location: Berlin, Select state..., France

Event Date/Time: May 21, 2012 End Date/Time: May 23, 2012
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This is a basic overview course intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post-marketing studies, and in the health care setting following product launch.

What You Will Learn
Legal basis for safety reporting, including a historical perspective
Basic definitions and tools
Data collection and processing in post-marketing phase
Medical evaluation
Safety reporting requirements in pre-marketing phase
A workshop and practical exercises
Safety reporting requirements in the post-marketing phase
An introduction to risk communication
Inspections in pharmacovigilance
Introduction to risk management, epidemiological methods for signal detection, and risk assessment

Who Should Attend
Individuals with limited experience in the clinical safety/pharmacovigilance area
Individuals from the pharmaceutical industry, academia, and regulatory authorities
Medical writers
Marketing personnel
Individuals who need an overview of clinical safety and may interact with members of those departments

Learning Objectives
Participants who complete this course should be able to:
Identify the history, principles, and regulatory framework for clinical safety/pharmacovigilance
Discuss the basic definitions of terms used in day-to-day work
Recognize EU, US, and international safety surveillance regulatory requirements
Describe the criteria and elements of expedited and periodic reporting of drug safety from phase I studies to post-marketing
Demonstrate an awareness of risk management and pharmacoepidemiology

Event Code:12562