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Session 2: Pharmacovigilance System Oversight
Session Chair(s)
Gemma Jimenez Sese
Senior Director, Deputy EU QPPV
AstraZeneca, Spain
Kiernan Trevett, MSc
Principal Quality Lead, PDQ Quality Assurance Process GVP
Genentech, A Member of the Roche Group, United States
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
AbbVie, Germany
EU and UK QPPV
QPPV Perspective On Key Oversight Tools
Jose Alberto Ayala Ortiz, MPharm, MSc
PVpharm, Spain
QPPV
Mergers And Acquisitions- How QPPV Keeps Up Oversight Over The Process
Gabrielle Amselem, PharmD
Alexion, AstraZeneca Rare Disease, France
Dir, Pharmacovigilance Excellence Expert
PV Audit Strategy and Use of Data Analytics
Hayley Fletcher
Roche Products Ltd., United Kingdom
Principal Quality Lead, PDQ Quality Assurance Process GVP