Please join us for an Open Scientific Discussion (OSD): Current Practices for qPCR/dPCR in Regulated Bioanalysis (Part 1) on Tuesday March 28 from noon to 1 pm EST hosted by the AAPS Biomarkers and Precision Medicine (BPM), Bioanalytical (BA), and Gene and Cell Therapy Products (GCTPs) Communities. Please feel free to share with colleagues who may be interested in this topic.
Where: https://global.gotomeeting.com/join/305789893
United States: +1 (872) 240-3412 Access Code: 305-789-893
Meeting ID: 305 789 893
Discussion Leaders: @Mikael Kubista Jim Huggett (University College London), and @Amanda Hays
- 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?
Background material:
MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCRhttps://global.gotomeeting.com/join/305789893
Digital MIQE Guidelines: Minimum Information for Publication of Quantitative Digital PCR
ISO - ISO 20395:2019 - Biotechnology - Requirements for evaluating the performance of
Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories - AAPS
Organized by: @Lakshmi Amaravadi, @Carmen Fernandez-Metzler@Karen Quadrini, and @Yan Ni
Thank you,
The Leadership Teams of the AAPS BPM, BA, and GCTPs Communities
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Rockville MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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