New EU Legislation on Pharmacovigilance


13th April, 2012
Time: 14:30 - 15:30

New EU Legislation on Pharmacovigilance: Immediate Impact for MAH

Location: Online Webinar
Timezone: (GMT) Western Europe Time, London, Lisbon, Casablanca

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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
Click here to read biography

Expert Panelists

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


Dr. Ricardo Seminario, MD
Director
Medical & Safety Services
ICON Clinical Research
Click here to read biography

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