Marta Thomsen
Marta Thomsen works in Device & Digital Safety; Operations, Technology & Analytics, Global Patient Safety, AstraZeneca, Munich, Germany; and Oncology Translational Medicine, AstraZeneca, Munich, Germany.
JournalA year of clinical trials under IVDR:
a sponsor’s perspectiveThis has led to differences in interpretation between IVD manufacturers, investigational drug sponsors, ethics committees and regulators across Europe, resulting in delays to initiation of clinical trials. A coordinated consultation process is urgently needed, alongside clear guidance on the interface between the Clinical Trial Regulation (CTR) and IVDR, to address ...