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Clinical Trials with Decentralised Elements
Session Chair(s)
Cécile Mathilde Ollivier, MS
Vice President, Global Affairs - Managing Director, Europe, 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)
Alison Bond, PHD
Director, Global Regulatory and R&D Policy, Amgen, United Kingdom
Decentralised Elements as Part of the Clinical Trial Toolbox to Promote Innovation and Benefit Patients – Are We There Yet?
Cathelijne De Gram, PHARMD, RAC
Regulatory Policy Director, J&J, Netherlands
Peter Mol, PHARMD, PHD
CHMP member, NL, MEB, Netherlands
How Will Regulators Perceive Data Created in Decentralised Trials? Recent Experience from Covid and Beyond.
Pamela Tenaerts, MD, MBA
Chief Scientific Officer, Medable, United States
Gabriele Schwarz, MPHARM
EC ICH E6(R3) Expert Working Group Member, Germany
Panelist
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