Biomarkers and Precision Medicine Community (BPMC)

The European Union (EU) In Vitro Diagnostic Regulation (IVDR): Assessing the Impact on Clinical Trials

• What are the differences between CLIA and IVDR from a regulatory perspective?
• What are the requirements under the IVDR for assays and labs that support subject screening for clinical trials in the EU?
• What are the options for sponsors planning new clinical trials in the EU?

Discussion Leaders:

Mark Ma (Rally Bio), Anna Lauren (EBF), and Manuela Braun (Bayer)

Organized by:

Yan Ni (Passage Bio), Yanmei Lu (Sangamo Therapeutics), Karen Quadrini (Passage Bio), and Carmen Fernández-Metzler (PharmaCadence)

#Biomarkers
#IVDR
#OSD