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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
Former Senior Director Device & Digital Safety - AstraZeneca, Visiting Lecturer - Pharmacovigilance MSc Course, University of Hertfordshire, 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
Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Utilization of Digital Health: What Implementation Means for Safety in the Clinical and/or Post-Market Space?
Michael Von Forstner, PhD, MPH, MSc
Chief Science Officer, MedGenie AG, Switzerland
How Medical Devices are Being Used to Aid Pharmacovigilance?
David John Lewis, PhD
Former Head QPPV PRRC Office, Patient Safety & Pharmacovigilance, Novartis Pharma Gmbh, Switzerland
How Medical Devices are Being Used to Aid Pharmacovigilance?
Mick Foy
Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
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