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
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
Vice President, QPPV Office
View Bio
-
Susanna Heinonen
EU/EEA QPPV
View Bio
-
David Lough
Senior PV Consultant
View Bio