Specialized Workshop M2 - Monday April 12, 2027: 7am to 5:30pm - Discussion Topic List
"Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
Session 1: Overcoming Sample Collection/Stability Issues during BAV & Clinical Biomarker Analysis
Session 2: Sophisticated IVD & CDx Assay Strategies to meet Regulatory Requirements
Session 3: COU Limitations & Enhanced Solutions for Overcoming Issues in Complex Biomarkers Development
Session 4: Novel/Alternative Approaches in FFP BAV: Linearity, Automation, Cross-validation, Singlicate
Session 5: 2027 White Paper in Bioanalysis
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2027 White Paper on Biomarkers Discovery, Development, Validation & Regulatory Approval
Consensus & Conclusions on Biomarkers Discovery, Development, Validation & Regulatory Approval for 2027 White Paper
Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
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Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Biomarkers & CDx/BAV
Regulatory Panelists: