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Hotel Casa Amsterdam

2025 年 11 月 18 日 8:30 上午 - 2025 年 11 月 20 日 4:00 下午

Eerste Ringdijkstraat 4, NL-1097 Amsterdam, Netherlands

Global Forum for Qualified Persons for Pharmacovigilance (QPPV)

This Forum continues to be the ONLY conference designed by QPPVs, for QPPVs - uniting leaders, subject matter experts, and peers in a dedicated setting for open exchange, practical learning, and professional growth.

Session 4: Tech It or Leave It? PV Innovation in Practice

Session Chair(s)

Gemma  Jimenez Sese

Gemma Jimenez Sese

Senior Director, Deputy EU QPPV

AstraZeneca, Spain

Willemijn  van der Spuij, MSc

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)

Jan  Cleerbout, MD

Where Is Technology Making a Difference in Pharmacovigilance Today?

Jan Cleerbout, MD

Johnson & Johnson, Belgium

Senior Director, deputy EU QPPV

Jean-Marie  Heim

Is QPPV the one to be the expert in tech, automation and AI?

Jean-Marie Heim

Takeda, Belgium

Vice-President, Head of EU QPPV Office, Takeda EU/EEA QPPV

Indy  Ahluwalia

Indy Ahluwalia

ELIQUENT Life Sciences, United Kingdom

Senior Managing Consultant

Christine   Prendergast

How technology is being inspected? Lessons learnt from first experiences.

Christine Prendergast

Health Products Regulatory Authority (HPRA), Ireland

GCP/PV Inspection Manager

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