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Ask the Experts: QPPV – What is it?

Post thumbnail Ask the Experts: QPPV – What is it?

Before submitting your marketing application in Europe or the UK, thinking about the PharmacoVigilance System and its Qualified Person (QPPV) is key for successful product development – at the time of submission, a PV system must be in place and a QPPV must be declared.

In this session, we aim to guide your way through EU and UK requirements for QPPVs toward your marketing application and beyond, by answering questions such as:
Who can act as QPPV?
What authority will they require over the PV system and how is this authority represented?
What does a QPPV do on a daily basis through Marketing Authorisation Application, approval and the rest of the product lifecycle?
When and how should the QPPV be declared?
Where are the QPPV responsibilities detailed?

We will answer all your QPPV-related questions!

Download: Answers to the key questions

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    Featured Speakers

    Hayley Marsh thumbnail
    Hayley Marsh
    Senior Vigilance Scientist
    Hayley leads the QPPV Back Office and Regulatory Surveillance team at VCLS, a team that performs all “behind the scenes” activities required to maintain a PV system and ensures internal tools and processes are updated for regulatory purposes and optimised for efficiency.
    Fidelma Reid thumbnail
    Fidelma Reid
    Senior Director Vigilance Operations
    Fidelma has extensive experience in pharmacovigilance and safety risk management for development compounds and marketed products. Her deep knowledge of related areas (including medical information, quality assurance and clinical research) have served her well, since she was first appointed as an EU QPPV in 2008. Subsequently, she has been QPPV for a variety of companies including generic and innovative pharma and CROs.
    Sophie Jaillet thumbnail
    Sophie Jaillet
    Global Head, Vigilances
    With 15+ years of experience in outsourced Vigilance Services, Sophie leads the Vigilance Business Unit at VCLS and coordinates all activities in order to propose compliant PV systems and their QPPVs, when and where applicable. Her own experience as QPPV helps her to better anticipate the burdens borne by the role and, with her team, enables her to build the most efficient solutions.