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).
ABOUT THE DRUG INFORMATION ASSOCIATION (DIA)
DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, academic, and regulatory professionals. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
Contact: Katie Shearer McKinnon
DIA in Europe
+41 61 225 51 36