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Pharmacovigilance Strategies Workshop

Navigating the changing PV landscape in your daily work. Anniversary edition: 5 years


Session 5: Impact Of Digital Health And How It Is Managed. What Medical Device Regulation Means For Pharmacovigilance

Session Chair(s)

James  Whitehead, MSc

James Whitehead, MSc

  • Patient Safety Medical Device Lead
  • Astrazeneca, United Kingdom
With digital health and medical devices revolution influencing how patients are diagnosed, monitored and have their medicine admini stered industry and regulators have the challenge to keep up. This session will look at how digital health tools, such as e-diaries, are being used and how regulators view their compliance with requirements as well as how medical devices can aid the goal of pharmacovigilance.

Speaker(s)

Beatrice  Panico

Utilization of digital health and what the implementation means for safety in clinical trials

Beatrice Panico

  • Senior Medical Assessor, Clinical Trials Unit
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Michael  Forstner, PhD

Utilization of Digital Health: What Implementation Means for Safety in the Clinical and/or Post-Market Space?

Michael Forstner, PhD

  • Head of Clinical and Patient Safety
  • Biogen BBU, Switzerland
David John Lewis, PhD

How Medical Devices are Being Used to Aid Pharmacovigilance?

David John Lewis, PhD

  • EU QPPV Head QPPV Office
  • Novartis Pharma AG, Switzerland
Mick  Foy

How Medical Devices are Being Used to Aid Pharmacovigilance?

Mick Foy

  • Head of Pharmacovigilance Strategy
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom