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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
Novartis Pharma AG, Switzerland
Regulatory Policy & Intelligence Director
Ethical Side of Digitalisation of Clinical Trials
Ghislaine Van Thiel, PhD, MSc
University Medical Center Utrecht, Netherlands
Ass. Professor Medical ethics
Regulators Perspective on Expectations for the Future?
Greet Musch, PhD
FAMHP, Belgium
strategic adviser
Patient Organisations – Advantages and Disadvantages of Digitalisation
Jan Geissler, MBA
Patvocates, Germany
Managing Director
Panel discussion with Q&A, with participation of:
Ruediger Pankow, DrSc
Independent Consultant, Germany
Clinical Regulatory Affairs Expert, CTIS SME
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