Date(s) And Time(s):
Apr 21 2010 7:00AM - Apr 22 2010 5:00PM
Location:
Hilton London Metropole
225 Edgeware Road
London
W2 1JU
United Kingdom
http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?pr...
Interest Area(s):
Clinical Safety/Pharmacovigilance, Outsourcing
Overview:
European legislation such as Volume 9A requires all marketing authorisation holders to have one Qualified Person for Pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of the company’s global pharmacovigilance system. Although acknowledged to be a vital function, there is little practical guidance on how QPPV responsibilities should best be conducted, while maintaining compliance with regulatory requirements, particularly in complex or challenging situations. The jurisdiction of the QPPV stretches to wherever there is an active licence for a product authorised in the EU. Thus the role in many companies has a global impact. During this meeting we will discuss and advise on current practice to help QPPVs perform their job more efficiently
Target Audience:
• European Qualified Persons for Pharmacovigilance
• Deputy Qualified Persons
• Senior Pharmacovigilance Regulators and Inspectors
• CRO and Consultants providing QPPV Services
• National Responsible Persons for Pharmacovigilance
Contact Information:
DIA EUROPE
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG
