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Session 5: De-Centralization of Clinical Trials – Different Stakeholder Perspectives
Session Chair(s)
Elke Stahl, PhD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Getting insight in different stakeholders’ perspectives on decentralised clinical trials. Their experiences with decentralised elements gained in clinical (hybrid) trials - the advantages and challenges.
Speaker(s)
Sponsors Perspective
Mireille Muller, DRSc, PhD, MSc
Regulatory Policy & Intelligence Director, Novartis Pharma AG, Switzerland
Ethical Side of Digitalisation of Clinical Trials
Ghislaine Van Thiel, PhD, MSc
Ass. Professor Medical ethics, University Medical Center Utrecht, Netherlands
Regulators Perspective on Expectations for the Future?
Greet Musch, PhD
strategic adviser , FAMHP, Belgium
Patient Organisations – Advantages and Disadvantages of Digitalisation
Jan Geissler, MBA
Managing Director, Patvocates, Germany
Panel discussion with Q&A, with participation of:
Ruediger Pankow, DRSc
Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany