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Session 3: Part I: Real-World Evidence in Regulatory and HTA Decision Making: Report on MetReal Cluster covering 5 European Horizon Europe Projects
Session Chair(s)
Jesper Kjær, MS
Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs
Novo Nordisk, Denmark
A total of five EU Horizon Europe projects have been funded for 4 – 5 years of research into what can make RWE regulatory acceptable. Participants come from patient organisations, hospitals, technology vendors, pharmaceutical industry, HTA bodies and medicines regulatory agencies. We will in this session explore the topics of real world and synthetic data and the use of artificial intelligence to create digital twins in clinical trials across the five projects. The output from these initiatives will create the principles for regulatory acceptance of new types of data and methods in clinical trials in the years to come.
Speaker(s)
Real4Reg Project
Britta Hänisch
BfArM, Germany
Head of Division Research
More-Europa Project
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
REDDIE Project
Martina Radanovic
RISE - Research and Innovation Services, Croatia (Hrvatska)
Project Manager
Realm Project
Gokhan Ertaylan
VITO, Belgium
Research Lead
Oncovalue Project
Pekka Kahri
HUS, Finland
Technology Officer
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