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Sep 07, 2021 7:00 PM - Sep 10, 2021 12:30 AM

4051 Basel, Switzerland

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.


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, MPH, MSc

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

David  Lewis, PhD

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

Mick  Foy

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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