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Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

Session 2: Pharmacovigilance System Oversight

Session Chair(s)

Gemma  Jimenez Sese

Gemma Jimenez Sese

  • Patient Safety Director, EU QPPV
  • Almirall, S.A., Spain
Kiernan  Trevett, MSc

Kiernan Trevett, MSc

  • Principal Quality Lead, PDQ Quality Assurance Process GVP
  • Roche, United Kingdom

Oversight of the global pharmacovigilance system is one of the fundamental and principal responsibilities of the qualified person for pharmacovigilance. GVP Module I outlines the specific expectations in relation to maintaining system and medicinal product oversight, and the wide breadth of this responsibility undoubtedly offers challenges in the context of complex and ever-changing organisations and PV systems.

The purpose of this session is to share practical examples of how oversight can be effectively maintained in different types of organisations and scenarios, including an overview of key tools and methodologies to facilitate QPPV oversight, how data analytics can support PV audit strategy and a business case on how to maintain QPPV oversight during company mergers and acquisitions.


Sina  Schader, DrMed

QPPV Perspective On Key Oversight Tools

Sina Schader, DrMed

  • EU and UK QPPV
  • AbbVie, Germany
Jose Alberto Ayala  Ortiz

QPPV Perspective On Key Oversight Tools

Jose Alberto Ayala Ortiz

  • QPPV
  • PVpharm, Spain
Gabrielle  Amselem

Mergers And Acquisitions- How QPPV Keeps Up Oversight Over The Process

Gabrielle Amselem

  • Deputy EU/UK QPPV
  • Alexion, France
Hayley  Fletcher

PV Audit Strategy and Use of Data Analytics

Hayley Fletcher

  • Principal Quality Lead, PDQ Quality Assurance Process GVP
  • Roche Products Ltd., United Kingdom

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