Global Forum for Qualified Persons for Pharmacovigilance (QPPV)
Session 2: Pharmacovigilance System Oversight
Session Chair(s)
Gemma Jimenez Sese
- Patient Safety Director, EU QPPV
- Almirall, S.A., Spain
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.
Speaker(s)
QPPV Perspective On Key Oversight Tools
Sina Schader, DrMed
- EU and UK QPPV
- AbbVie, Germany
QPPV Perspective On Key Oversight Tools
Jose Alberto Ayala Ortiz
- QPPV
- PVpharm, Spain
Mergers And Acquisitions- How QPPV Keeps Up Oversight Over The Process
Gabrielle Amselem
- Deputy EU/UK QPPV
- Alexion, France
PV Audit Strategy and Use of Data Analytics
Hayley Fletcher
- Principal Quality Lead, PDQ Quality Assurance Process GVP
- Roche Products Ltd., United Kingdom
