Volver a Agenda
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)
Sarah Vaughan
Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
MHRA / Regulatory Perspective
James Whitehead, MBA, MSC
Former Senior Director Device & Digital Safety - AstraZeneca, Visiting Lecturer - Pharmacovigilance MSc Course, University of Hertfordshire, United Kingdom
Digital Solutions – What the QPPV Needs to Know
Barbara Bovy
Quality Auditing and Center of Excellence, Quality Assurance, UCB, Belgium
Control of Digital Activities – Validation, Compliance Monitoring, Audit and Inspection of and using Digital/AI tools
¿Tiene una cuenta?