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4th European Forum for Qualified Person for Pharmacovigilance Will Explore Roles and Expectations of the QPPV

Basel, Switzerland — Mar 29, 2010

The Drug Information Association (DIA) in Europe will host the 4th European Forum for Qualified Person for Pharmacovigilance (QPPV) from 21-22 April in London, UK.

This two-day meeting will discuss the current complex environment to help QPPVs perform their job more efficiently. Attendees will learn about:

  • Roles and expectations of the QPPV in the context of the proposed new regulatory framework and updates to Volume 9a and transparency initiatives
  • Upcoming areas of real challenge for the QPPV such as mergers, outsourcing and complex marketing situations
  • Legal aspects and associated liabilities for the QPPV
  • Regulatory and inspectorate expectations of the QPPV

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. This meeting will feature sessions focusing on the following topics:

  • Perspectives on EU Legislation Framework
  • Achieving  QPPV Oversight  in the Modern Business Environment
  • QPPV Potential Areas of Liability
  • Interfaces with the QPPV
  • Role of the QPPV in Mergers and Acquisitions
  • Role of QPPV in the Implementation and Management of Risk Management Plans and in  Transparency Initiatives
  • QPPV Influence and Models

Register for the 4th European Forum for Qualified Person for Pharmacovigilance (QPPV).

 

 

 

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.

Contact: Katie Shearer McKinnon
DIA in Europe
+41 61 225 51 36
Katie.McKinnon@diaeurope.org