Open Scientific Discussion (OSD) on The EU IVDR: Assessing the Impact on Clinical Trials

When:  Jun 1, 2023 from 12:00 to 13:00 (ET)

Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM) and Gene and Cell Therapy Products (GCTPs) Communities on June 1, 2023, 12 pm – 1 pm EST on the following topic:

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)


We start at 12:00 EST sharp. To avoid interruptions, please dial in before noon and mute yourself until Q&A starts.

(Please remain on mute unless asking questions)


When: Thursday, June 1, 2023, 12 pm – 1 pm EST

WherePlease join from your computer, tablet or smartphone.

You can also dial in using your phone.
United States: 
+1 (872) 240-3412
Access Code: 305-789-893

Join from a video-conferencing room or system.
Dial in or type: or
Meeting ID: 305 789 893
Or dial directly: 
[email protected] or

New to GoToMeeting? Get the app now and be ready when your first meeting starts:


Thank you,

The OSD Organizing Teams

Download to Your Calendar Outlook Google


Carmen Fernandez-Metzler
(215) 853-2627
[email protected]