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Clinical Trials and Data Science Conference
Plenary Session 1: Digitalisation of Clinical Data and its Support to Clinical Research
Session Chair(s)
Nick Sykes, MS
- Senior Director, Global Regulatory Affairs
- Pfizer Inc, United Kingdom
Jesper Kjær, MS
- Co-Chair, EMA/HMA Big Data Steering Group; Director of 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
- Policy Officer - Digital Health
- European Commission, Belgium
Use of Digital Health Technologies for Capturing Clinical Trial Data – Opportunities & Pitfalls
Bert Hartog, PhD, MSc
- Senior Director, Clinical Innovation, R&D Development
- Janssen Pharmaceutica, Netherlands
ACT EU – Supporting the Digitalisation of CTs
Ana Zanoletty Perez
- Programme Manager for ACT EU
- European Medicines Agency, Netherlands