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Session 4: Tech It or Leave It? PV Innovation in Practice
Session Chair(s)
Gemma Jimenez Sese
Senior Director, Deputy EU QPPV, AstraZeneca, Spain
Willemijn van der Spuij, MSC
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland
This session is dedicated to the use of advanced technologies including AI in Pharmacovigilance and will look at its use in pharma as well as how regulators use it. We will explore how these advance technologies are transforming the way we monitor and ensure the safety of medicines, from streamlining case processing to identifying safety signals more efficiently. We will also discuss particularly how AI systems are inspected and validated to meet regulatory standards, how regulators use AI, and consider the important question: as advanced cognitive technologies such as AI becomes more integrated into our daily work, do we all need to become experts on this topic? Join us to continue diving into the opportunities, challenges, present and future of advanced technologies in pharmacovigilance with a focus on the role of the QPPV.
Speaker(s)
Where Is Technology Making a Difference in Pharmacovigilance Today?
Senior Director, deputy EU QPPV, Johnson & Johnson, Belgium
Is QPPV the one to be the expert in tech, automation and AI?
Vice-President, Head of EU QPPV Office, Takeda EU/EEA QPPV, Takeda, Belgium
Indy Ahluwalia
Senior Managing Consultant, ELIQUENT Life Sciences, United Kingdom
How technology is being inspected? Lessons learnt from first experiences.
GCP/PV Inspection Manager, Health Products Regulatory Authority (HPRA), Ireland
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