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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, 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)
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 Forstner, PhD, MPH, MSc
Head of Global Safety Science
SOBI, Switzerland
How Medical Devices are Being Used to Aid Pharmacovigilance?: David Lewis, PhD
Head QPPV PRRC Office, Chief Medical Office & Patient Safety
Novartis Pharma AG, Switzerland
How Medical Devices are Being Used to Aid Pharmacovigilance?: Mick Foy
Deputy Director of Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
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