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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)
Impact of IVDR on Clinical Development Efforts
Claudia Popp
F. Hoffmann-La Roche Ltd, Switzerland
Head EU Regulatory Science and EMA Liaison
Critical Impact of IVDR Implementation on Clinical Trials & Patients: How Do We Keep Clinical Research & Innovation in Europe
Alison Bond, PHD
Amgen, United Kingdom
Director, Global Regulatory and R&D Policy
Broader Patient Perspective on the Relevance of IVDs
Claudia Louati, MA, MSC
European Patients' Forum, Belgium
Head of Policy
Olga Tkachenko, PHD
European Commission, Belgium
Policy Officer