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Clinical Trials with Decentralised Elements
Session Chair(s)
Cécile Mathilde Ollivier, MS
VP Global Affairs
Critical Path Institute, Netherlands
Monique Al, PhD
Special advisor CCMO
Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Dimitrios Athanasiou, MBA
Patient Advocate
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece
This session will discuss the evolving global landscape for decentralised clinical trials, to (1) impact of recent and ongoing DCT initiatives and activities by various stakeholders (2) evaluate where we are in fulfilling the promise of DCTs for each stakeholder (3) debate what still needs to be done to advance the use of decentralised elements.
Learning Objective : This session will discuss the evolving global landscape for decentralised clinical trials, to (1) Discuss impact of recent and ongoing DCT initiatives and activities by various stakeholders (2) evaluate where we are in fulfilling the promise of DCTs for each stakeholder (3) debate what still needs to be done to advance the use of decentralised elements to promote innovation and benefit patients.
Speaker(s)
Decentralised Elements as Part of the Clinical Trial Toolbox to Promote Innovation and Benefit Patients – Are We There Yet?
Alison Bond, PhD
Amgen, United Kingdom
Director, Global Regulatory and R&D Policy
Cathelijne De Gram, PharmD, RAC
J&J Innovative Medicine, Netherlands
EMEA Regulatory Policy Lead
How Will Regulators Perceive Data Created in Decentralised Trials? Recent Experience from Covid and Beyond.
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
Pamela Tenaerts, MD, MBA
Medable, United States
Chief Scientific Officer
Panelist
Gabriele Schwarz, MPharm
Federal Institute for Drugs and Medical Devices (BfArM), Germany
GCP Strategy Expert
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