Back to Agenda
Session 2: Platform Trials in Europe: EU PEARL Project and the ACT EU Vision
Session Chair(s)
Daniel Millar, MBA
Senior Director, Strategic Business Transformation, Johnson & Johnson, United States
The European Union-Patient-cEntric clinicAl tRial pLatform (EU-PEARL) initiative has developed new methodologies and tools to expand the master protocol approach into Integrated Research Platforms (IRPs) in collaboration with patient representatives and through consultation with FDA and EMA stakeholders. This session will highlight the deliverables now available to the clinical trial community, the path forward for IRPs in Europe, and the connection to the broader Accelerating Clinical Trials (ACT) EU vision.
Speaker(s)
Integrated Research Platform concept and key deliverables from EU PEARL
, Netherlands
IRP for Major Depressive Disorder
Professor, Charité Universitätsmedizin Berlin, Germany
IRP for Major Depressive Disorder
, Patient Community Representative, Switzerland
Study Design and Statistical Methods for platform trials, including Regulatory guidance
Associate Professor, Medical University of Vienna, Austria
Study Design and Statistical Methods for platform trials, including Regulatory guidance
Head of Data Science and Methods, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Regulatory Perspective on IRPs: Experience with EU CTR to support Complex Clinical Trials.
Clinical assessor, Federal Agency for Medicines and Health Products, Belgium
Have an account?