Maria Fernandez
Maria Fernandez works in Oncology Regulatory Science Strategy and Excellence, AstraZeneca, Cambridge, UK.
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 ...