Sabina Patel

Sabina Patel works in Precision Medicine and Biosamples, AstraZeneca R&D, Cambridge, UK. 

  • EU-IVDR-3-to-2

    A year of clinical trials under IVDR:
    a sponsor’s perspective

    This 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 ...