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Plenary Session 1: Digitalisation of Clinical Data and its Support to Clinical Research
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy
EFPIA, Belgium
Jesper Kjær, MS
Director of DKMA Data Analytics Centre
Danish Medicines Agency DKMA, Denmark
To remain sustainable, clinical research needs to fully embrace digitalisation. This session will take a look at how the clinical research environment is being digitalised; from how data on people’s health is being made available, to using digital technologies for the capture of data from participants in clinical trials. The session will also look at how data other than that collected in traditional clinical trials can be used to complement clinical trial data and what EU regulators are doing to prepare for this digital future.
Speaker(s)
The Promise of the European Health Data Space (EHDS)
Jerome De Barros, MS
European Commission, Belgium
Policy Officer - Digital Health
Use of Digital Health Technologies for Capturing Clinical Trial Data – Opportunities & Pitfalls
Bert Hartog, PHD, MSC
Janssen Pharmaceutica, Netherlands
Senior Director, Clinical Innovation, R&D Development
ACT EU – Supporting the Digitalisation of CTs
Ana Zanoletty Perez
European Medicines Agency, Netherlands
Head of Clinical Trials Transformation Workstream