How to Setup an Effective PV System in the UK and EU/EEA

An essential guide to PV system implementation in the UK and EU/EEA. 

Date: June 20, 2024 

Time: 10:00-11:00AM US EST / 4:00-5:00 PM CEST

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About the Webinar

Are you ready to take your Pharmacovigilance (PV) system to the next level in Europe? Join us for an informative webinar hosted by ProPharma’s QPPV experts, designed to provide you with a comprehensive roadmap for setting up an efficient PV system. Our seasoned professionals will guide you through the entire process, from the initial application for a marketing authorization to the product's successful launch.

This webinar will focus on the unique requirements and regulations in the UK and EU/EEA, highlighting critical areas such as the role of the Qualified Person for Pharmacovigilance (QPPV), the importance of the Pharmacovigilance System Master File (PSMF), and the integration of local legislations to ensure compliance. Our experts will share practical insights and strategies to optimize your PV system, ensuring it meets all regulatory demands while maintaining operational efficiency.

What You Will Learn

  • Implementing a PV System: Get detailed insights into the strategic planning required for setting up a robust PV system, ensuring all regulatory requirements are met.
  • The QPPV: Understand the pivotal role of the QPPV in establishing and managing an effective PV system, including their responsibilities and best practices.
  • The PSMF: Learn the essential components of the Pharmacovigilance System Master File (PSMF), and how it serves as the cornerstone of your PV system, providing a comprehensive overview to regulatory bodies.

Who Should Attend?

This webinar is ideal for pharmaceutical and biotech professionals planning to enter the EU/EEA and UK markets for the first time. It is particularly relevant for those working in the following areas:

  • Pharmacovigilance
  • Regulatory
  • Clinical
  • Commercial  

Unable to join? Register and you will receive the recording after the live session.

Meet the Speakers

  • Thomas Chatzopoulos Bio Photo

    Thomas Chatzopoulos

    Vice President, QPPV Office

    View Bio

  • Susanna Heinonen Bio Photo

    Susanna Heinonen

    EU/EEA QPPV

    View Bio

  • David Lough Bio Photo

    David Lough

    Senior PV Consultant

    View Bio

Thomas Chatzopoulos brings over 25 years of Pharmacovigilance expertise, having held senior roles at leading pharmaceutical companies including Grünenthal, Novartis, and Boehringer Ingelheim. As Vice President of the QPPV Office at ProPharma, he oversees QPPV and LPPV activities, leveraging his extensive experience in setting up global PV systems and preparing them for audits and inspections.
Susanna Heinonen is a seasoned GxP professional with more than 14 years of experience in the pharmaceutical industry. She has a proven track record in setting up and monitoring GxP systems, and has worked in various consultancy and leadership roles. At ProPharma, Susanna applies her deep expertise in multinational projects, cross-functional collaboration, and vendor management.
David Lough is a Senior PV Consultant with 7 years of experience in pharmaceutical consultancy, specializing in UK QPPV/NCP roles, PSMFs, EU LPPV setup, and GVP Auditing. Based in the UK, David is known for his thorough understanding of drug safety practices and regulations across the UK and EU, bringing a highly motivated and detail-oriented approach to his role at ProPharma.