Meeting

4th European Forum for Qualified Person for Pharmacovigilance (QPPV)

Location: London, UK
Date: 21.04.2010
End Date: 22.04.2010

Description

European legislation and guidelines such as Volume 9A require all marketing authorisation holders to have a 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 far reaching impact outside the EU or may extend to products licensed by one or more affiliates or subject to co-marketing agreements. During this meeting we will discuss and draw on experience of handling these situations in the current complex environment to help QPPVs perform their job more efficiently.

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Contact

DIA in Europe
Elisabethenanlage 25
4002 Basel
http://www.diahome.org/
Sandra.Grass@diaeurope.org