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Pharmacovigilance Strategies Workshop

Engage in the sharing of good practices between industry representatives and seek advice from regulators in this unique workshop

Session 7: Medical Devices, Wearables, Combination Products

Session Chair(s)

Maarten  Lagendijk, MSc

Maarten Lagendijk, MSc

  • Deputy EU QPPV
  • MSD, Netherlands
James  Whitehead, MSc

James Whitehead, MSc

  • Patient Safety Medical Device Lead
  • 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.


Emma  Woods

Use of Wearables to Monitor Patients – Case Studies

Emma Woods

  • Astrazeneca, United Kingdom
David John Lewis, PhD

Digital Health & Medical Devices

David John Lewis, PhD

  • Head QPPV PRRC Office, Chief Medical Office & Patient Safety
  • Novartis Pharma AG, Switzerland
Abtin  Rad

Development and Approval Process for Medical Devices from a Regulator’s Perspective

Abtin Rad

  • Active Medical Products
  • TÜV SÜD, Germany

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