New EU Legislation on Pharmacovigilance

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The New European Legislation (Directive 2010/84/EC and Regulation (EC) No1235/2010) has considerable implications on the Pharmacovigilance (PV) system of every EU Marketing Authorization Holder (MAH); changes will start to be implemented by July 2012. This Legislation change will mean significant increase in the workload within PV departments. Industry expects a 20-30% increase alone in case volume.

Topics to be covered:

• The New European Legislation (Directive 2010/84/EC and Regulation (EC) No1235/2010.) 
•  Implications of the changes in the European Legislation on the Pharmacovigilance System of each Marketing Authorisation Holder. 
•  What comes next: Outlook on the EU "Good Vigilance Practice" Guideline, expected July 2012. 

Moderator

Dr. Peter Schüeler, MD
Senior VP
Global Medical & Safety Services
ICON Clinical Research
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Expert Panelists

Dr. Irina Baeumer, MD, Ph.D.
Senior Director
Medical & Safety Services
ICON Clinical Research
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Dr. Ricardo Seminario, MD
Director
Medical & Safety Services
ICON Clinical Research
Click here to read biography