Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Biomarkers and Precision Medicine (BPM), Bioanalytical (BA), and Gene and Cell Therapy Products (GCTPs) Communities on the following topic:
Current Practices for qPCR/dPCR in Regulated Bioanalysis (Part 1)
· What are the MIQE and ISO 20395:2019 guidelines and how do they inform PCR assay development and validation to ensure assay performance and quality?
· What other initiatives are in progress to address best practices for PCR testing in a regulated environment?
· What are the similarities and differences in recommendations amongst these guidelines for using qPCR/dPCR in regulated bioanalysis?
Discussion Leaders:
Mikael Kubista (TATAA Biocenter), Jim Huggett (University College London), and Amanda Hays (BioAgilytix)
Organized by:
Lakshmi Amaravadi (Dewpoint Therapeutics), Carmen Fernández-Metzler (PharmaCadence), Karen Quadrini (Passage Bio), and Yan Ni (Passage Bio)
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: Tuesday, March 28, 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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Yan Ni
Executive Director
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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