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
Where: Please join from your computer, tablet or smartphone.
https://global.gotomeeting.com/join/305789893
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: 67.217.95.2 or inroomlink.goto.com
Meeting ID: 305 789 893
Or dial directly: [email protected] or 67.217.95.2##305789893
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Please feel free to share with colleagues who may be interested in this topic.
Thank you,
The Leadership Teams of the AAPS BPM and GCTPs Communities
#biomarker #OpenScientificDiscussions #OSD
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Karen Quadrini, PhD
Associate Director, Biomarkers and Precision Medicine
Passage Bio
Philadelphia, PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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