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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
Quality Policy Lead, 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)
Sina Schader, DrMed
Head of QPPV Office and EU QPPV, AbbVie, Germany
QPPV Perspective On Key Oversight Tools
Jose Alberto Ayala Ortiz, MPHARM, MSC
CEO, PVpharm, Spain
QPPV Perspective On Key Oversight Tools
Gabrielle Amselem, PHARMD
Dir, Pharmacovigilance Excellence Expert, Alexion, AstraZeneca Rare Disease, France
Mergers And Acquisitions- How QPPV Keeps Up Oversight Over The Process
Hayley Fletcher
Principal Quality Lead, PDQ Quality Assurance Process GVP, Roche Products Ltd., United Kingdom
PV Audit Strategy and Use of Data Analytics
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