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Session 1: AI And Digitalization
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV
MSD, Netherlands
Elspeth McIntosh, MBA, RN
Director
Castle Pharmacovigilance Ltd, United Kingdom
Artificial intelligence and digital activities are creating quite a buzz in a range of different professions, but what does it mean for QPPVs? In this session we will try to give you an overview of regulatory developments, help you understand what QPPVs need to know to enable oversight of new activities and provide ideas for managing compliance, with presenters from a range of backgrounds. We also invite you to discuss with us where technological developments could take PV and the QPPV role in the future.
Speaker(s)
MHRA / Regulatory Perspective
Sarah Vaughan
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Head of Vigilance Operations
Digital Solutions – What the QPPV Needs to Know
James Whitehead, MBA, MSc
AstraZeneca, United Kingdom
Senior Director, Device & Digital Safety
Control of Digital Activities – Validation, Compliance Monitoring, Audit and Inspection of and using Digital/AI tools
Barbara Bovy
UCB, Belgium
Quality Auditing and Center of Excellence, Quality Assurance