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Virtual

Dec 01, 2021 1:30 PM - Dec 02, 2021 6:40 PM

(Central Europe Standard Time)

Clinical Trial Regulation Conference

Join experts from regulatory, ethics bodies, sponsors and patients to discuss the launch of the Clinical Trial Regulation and new trends of Clinical Trials in Europe.

Session 5: De-Centralization of Clinical Trials – Different Stakeholder Perspectives

Session Chair(s)

Elke  Stahl, PHD

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)

Mireille  Muller, DRSC, PHD, MSC

Mireille Muller, DRSC, PHD, MSC

Regulatory Policy & Intelligence Director, Novartis Pharma AG, Switzerland

Sponsors Perspective

Ghislaine  Van Thiel, PHD, MSC

Ghislaine Van Thiel, PHD, MSC

Ass. Professor Medical ethics, University Medical Center Utrecht, Netherlands

Ethical Side of Digitalisation of Clinical Trials

Greet  Musch, PHD

Greet Musch, PHD

strategic adviser , FAMHP, Belgium

Regulators Perspective on Expectations for the Future?

Jan  Geissler, MBA

Jan Geissler, MBA

Managing Director, Patvocates, Germany

Patient Organisations – Advantages and Disadvantages of Digitalisation

Ruediger  Pankow, DRSC

Ruediger Pankow, DRSC

Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany

Panel discussion with Q&A, with participation of:

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