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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
Director for Public, Private Partnerships - Science, Policy & Intelligence, Novo Nordisk A/S, 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)
Britta Hänisch
Head of Division Research, BfArM, Germany
Real4Reg Project
Peter Mol, PharmD, PhD
CHMP member, NL, MEB, Netherlands
More-Europa Project
Martina Radanovic
Project Manager, RISE - Research and Innovation Services, Croatia
REDDIE Project
Gokhan Ertaylan
Research Lead, VITO, Belgium
Realm Project
Pekka Kahri
Technology Officer, HUS, Finland
Oncovalue Project
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