Main Workshop DAY 2A - Wednesday April 14, 2027: 7am - 12:30pm - Discussion Topic List

"Regulators' Advice on Bioanalytical Method Validation (BMV) & Biomarkers Assay Validation (BAV)"

Session 1: Regulated Bioanalysis / BMV

ASK THE REGULATORS!

  • Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Italy AIFA / EU EMA, Health Canada, Brazil ANVISA
  • Ask the Regulators any questions you have on Regulated Bioanalysis / BMV, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes

Session 2: Biomarkers, IVD/CDx and BAV

ASK THE REGULATORS!

  • Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Belgium FAMHP / EU EMA
  • Ask the Regulators any questions you have on Biomarkers, IVD/CDx and BAV, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes