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Session 5: Impact Of Digital Health And How It Is Managed. What Medical Device Regulation Means For Pharmacovigilance
Session Chair(s)
James Whitehead, MBA, MSc
Senior Director, Device & Digital Safety
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)
Utilization of digital health and what the implementation means for safety in clinical trials
Beatrice Panico
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Senior Medical Assessor, Clinical Trials Unit
Utilization of Digital Health: What Implementation Means for Safety in the Clinical and/or Post-Market Space?
Michael Forstner, PhD, MPH, MSc
SOBI, Switzerland
Head of Global Safety Science
How Medical Devices are Being Used to Aid Pharmacovigilance?
David John Lewis, PhD
Novartis Pharma Gmbh, Switzerland
Head QPPV PRRC Office, Patient Safety & Pharmacovigilance
How Medical Devices are Being Used to Aid Pharmacovigilance?
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
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