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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

Nick Sykes, MS

  • Senior Director, Global Regulatory Affairs
  • Pfizer Inc, United Kingdom
Jesper  Kjær, MS

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.


Jerome  De Barros, MS

The Promise of the European Health Data Space (EHDS)

Jerome De Barros, MS

  • Policy Officer - Digital Health
  • European Commission, Belgium
Bert  Hartog, PhD, MSc

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
Ana  Zanoletty Perez

ACT EU – Supporting the Digitalisation of CTs

Ana Zanoletty Perez

  • Programme Manager for ACT EU
  • European Medicines Agency, Netherlands

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