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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

Sponsors Perspective

Mireille Muller, DrSc, PhD, MSc

Novartis Pharma AG, Switzerland

Regulatory Policy & Intelligence Director

Ghislaine  Van Thiel, PhD, MSc

Ethical Side of Digitalisation of Clinical Trials

Ghislaine Van Thiel, PhD, MSc

University Medical Center Utrecht, Netherlands

Ass. Professor Medical ethics

Greet  Musch, PhD

Regulators Perspective on Expectations for the Future?

Greet Musch, PhD

FAMHP, Belgium

strategic adviser

Jan  Geissler, MBA

Patient Organisations – Advantages and Disadvantages of Digitalisation

Jan Geissler, MBA

Patvocates, Germany

Managing Director

Ruediger  Pankow, DrSc

Panel discussion with Q&A, with participation of:

Ruediger Pankow, DrSc

Germany

Regulatory Affairs Expert, CTIS SME and PO

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