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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)
Mårten Wendt
Physician, Clinical Investigator, Swedish Medical Products Agency , Sweden
The Regulatory Perspective
Kasper Bendix Johnsen
Head of Section, Danish National Center For Ethics, Denmark
The Ethical Perspective
Eric Vermeulen
Policy Officer, , VSOP - Patient Alliance for Rare and Genetic Diseases, Netherlands
Patient perspective: How to Tailor Decentralised Clinical Trials to Patient Needs
Jianmei Wang
Senior Principal Statistical Scientist, Roche, United Kingdom
Current Experiences and Challenges from a Sponsor Perspective
Craig Lipset, MPH
Co-Chair, Digital Trials and Research Alliance, United States
With Additional Participation of
Abba Elizabeth Theogaraj, PHD
Regulatory Senior Group Director, Roche, Switzerland
With Additional Participation of