Innovative Therapies, Precision Medicine & Diagnostics
Scientific development in innovative therapies and precision medicine is evolving rapidly. More specifically, we are seeing potentially curative therapies not only in rare disease but also in development for prevalent conditions. We are currently at a turning point in Europe, where Regulators, policy makers and payers must adapt to address the dynamic environment and scientific evolution. Innovation in medicine only adds value when it reaches patients in time.
Who is This Track Designed For?
All developers of innovative therapies, precision medicines and diagnostics: global regulators, policy makers, industry leaders, academics, patients, HTA bodies representatives and payers.
Topic Leaders
Claudia Dollins
Vice President, Precision Medicines, Global Regulatory Affairs
GSK, United States
Michela Gabaldo
VP ATMP Global Regulatory Affairs
Evotec, Italy
Sophie Schmitz
Managing Partner
P4A Partners for Access, The Netherlands
Key Topics
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Day 2: Wednesday, March 13th, The Arc
Overcoming Barriers to ATMPs through Collaboration and Regulatory Reliance
IVDR (In-Vitro Diagnostics Regulation)
The future of precision medicines: how the regulatory framework keeps up with evolving science
RWE supporting HTA/Payers determine the Value of Highly Innovative Medicines
DIA Europe 2023 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.