Suzanne Jenkins
Suzanne Jenkins works in Precision Medicine and Biosamples, AstraZeneca R&D, Cambridge, UK.
- Journal
A 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 ...