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Session 4: Digital Health Technologies in Clinical Trials: Update on the State of Play: Decentralized Clinical Trials
Session Chair(s)
Elke Stahl, PhD
Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Monique Al, PhD
Special advisor CCMO
Central Committee on Research Involving Human Subjects (CCMO), Netherlands
The European Medicine Regulatory Network published a recommendation paper on clinical trials with decentralised elements last year. In this session perspectives from ethics, patients, industry and regulatory is given. Their experiences and challenges in practice and future considerations will be discussed.
Speaker(s)
The Regulatory Perspective
Mårten Wendt
Swedish Medical Products Agency , Sweden
Physician, Clinical Investigator
The Ethical Perspective
Kasper Bendix Johnsen
Danish National Center For Ethics, Denmark
Head of Section
Patient perspective: How to Tailor Decentralised Clinical Trials to Patient Needs
Eric Vermeulen
VSOP - Patient Alliance for Rare and Genetic Diseases, Netherlands
Policy Officer,
Current Experiences and Challenges from a Sponsor Perspective
Jianmei Wang
Roche, United Kingdom
Senior Principal Statistical Scientist
With Additional Participation of
Craig H Lipset, MPH
Clinical Innovation Partners, United States
Managing Partner
With Additional Participation of
Abba Elizabeth Theogaraj, PhD
Roche, Switzerland
Regulatory Senior Group Director
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