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Session 7: Medical Devices, Wearables, Combination Products
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV
MSD, Netherlands
James Whitehead, MBA, MSc
Senior Director, Device & Digital Safety
AstraZeneca, United Kingdom
The digitalisation of the care pathway is accelerating and the past 24 months has only increased the pace of the digital health and medical devices revolution. We are seeing the influence of devices & digital on how patients are diagnosed, monitored and have their medicine administered. Everyone involved in patient care, from MAH’s and Regulators to Hospitals and Pharmacies, is challenged to keep up. This session will look at how digital health tools and medical devices are being used in clinical trials, how they could be utilised in the post-marketing space and how regulators have to work across boundaries—all of this with the goal of enhancing patient safety.
Speaker(s)
Use of Wearables to Monitor Patients – Case Studies
Emma Woods
Astrazeneca, United Kingdom
Digital Health & Medical Devices
David John Lewis, PhD
Novartis Pharma Gmbh, Switzerland
Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
Development and Approval Process for Medical Devices from a Regulator’s Perspective
Abtin Rad
TÜV SÜD, Germany
Active Medical Products
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