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Session 4: Catalysing the integration of science and technology in medicines development
Session Chair(s)
Falk Ehmann, MD, PHD, MS
Head of Innovation and Development Accelerator
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Session 4: Catalysing the integration of science and technology in medicines development
Speaker(s)
Floodlight (Roche) RE digital challenges
Seya Colloud, PHARMD
F. Hoffmann-La Roche Ltd, Switzerland
Global Regulatory Director
Case study on Borderline/Combination product and consequent challenges for “joint” Pharma / Regulator / Notified Body assessment
Armin Ritzhaupt, PHD, MPH
European Medicines Agency, Netherlands
Scientific Administrator
Example and view from the Notified Body’s perspective
Astrid Hoepffner
TÜV SÜD Product Service GmbH, Germany
Senior Product Specialist Clinical Data / Clinical Reviewer
Support mechanisms from NCA, EU-IN and EMA side with a focus on Digital Technologies and Borderline Products
Laurence O'Dwyer, RPH
Health Products Regulatory Authority, Ireland
Scientific Affairs Manager
EMA Innovation task force / EMA regulatory science strategy
Falk Ehmann, MD, PHD, MS
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Head of Innovation and Development Accelerator
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