Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing

Venue: Radisson Blu Alcron Hotel

Location: Prague, Czech Republic

Event Date/Time: Jun 02, 2010 End Date/Time: Jun 04, 2010
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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 healthcare setting following product launch.

Key Topics

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-marketed 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

Learning Objectives:

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

Identify the history, the principles and regulatory framework for clinical safety/pharmacovigilance
Discuss the basic definitions of terms used in day-to-day work
Recognise 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