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Postmarketing Drug Safety & Pharmacovigilance

  August 20, 2011  
Crowne Plaza de Mexico, Mexico City, Mexico
Sep 2 2011 8:30AM - Sep 3 2011 2:45PM

Learn the key tools available for pharmacovigilance, discuss their current application,and consider future directions of the field. The focus will be on marketed biopharmaceutical products in a global context.


What You Will Learn

       Perspectives on the importance of pharmacovigilance, technovigilance, and vaccine vigilance

       Basics of US, European, and other global requirements for postmarketing drug safety

       Organisational aspects to consider in the context of pharmacovigilance obligations

       A day in the life of an Individual Case Safety Report

       How to speak the language of your pharmacovigilance colleagues

       Risk management and minimisation plans and their importance

       Why to consider pharmacovigilance audits and inspections in the context of SOPs, training, and documentation

       Predictions on the future of drug safety and pharmacovigilance

Learning Objectives:

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

     Identify the high-level ethical, legal, and regulatory basis for postmarketing medical product safety

     Describe at least three historical scenarios that have strengthened the pharmacovigilance system

     Explain current global requirements and challenges for case processing and aggregate reporting

     Outline US and EU regulatory requirements for Risk Management Plans and Risk Evaluation and Mitigation Strategies

     Assess how their organisation’s pharmacovigilance system might perform in an audit or inspection

     Apply principles learned to make their organisation’s pharmacovigilance unit more efficient, strengthen compliance, and better protect patient safety

Event Code:

Organized by: DIA
Invited Speakers: See website for speaker information
Deadline for Abstracts: Call contact
Contact Information:
For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108

E-mail: Colleen.Buckley@diahome.org
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