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IVDR (In-Vitro Diagnostics Regulation)
Session Chair(s)
Claudia Dollins, PHD, RAC
Vice President, Precision Medicines, Global Regulatory Affairs, GlaxoSmithKline, United States
IVDR (In-Vitro Diagnostics Regulation)
Learning Objective : What did we learn since May 2022? Share lessons learned the second year of the In Vitro Diagnostic Regulation (IVDR) implementation through a series of stakeholder presentations and an active debate. How is IVDR is driving innovative patient treatments in the EU and what are best practices to overcome challenges? What improvements are possible (with a focus on short-term)
Speaker(s)
Claudia Popp
Head EU Regulatory Science and EMA Liaison, F. Hoffmann-La Roche Ltd, Switzerland
Impact of IVDR on Clinical Development Efforts
Alison Bond, PHD
Director, Global Regulatory and R&D Policy, Amgen, United Kingdom
Critical Impact of IVDR Implementation on Clinical Trials & Patients: How Do We Keep Clinical Research & Innovation in Europe
Claudia Louati, MA, MSC
Head of Policy, European Patients' Forum, Belgium
Broader Patient Perspective on the Relevance of IVDs
Olga Tkachenko, PHD
Policy Officer, European Commission, Belgium
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