Main Workshop DAY 2A - Wednesday April 09, 2025: 7am to 12pm - Discussion Topic List

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

Session 1: Regulated Bioanalysis / BMV

  • US FDA:

    An update on the 2024 Guidance on Handing and Retention of BA and BE testing Samples & Collaboration and Information Sharing with other Agencies

  • Health Canada:

    Application of ICH M10: Health Canada Review of Comparative Bioavailability Studies

  • US FDA:

    An update on the New Data Integrity Draft Guidance

  • UK MHRA:

    Current Data Integrity Issues 

  • US FDA:

    Data Integrity and Data Quality Issues in BA/BE Studies – Understanding FDA's Data Integrity Guidance and Expectations.  

  • Health Canada:

    Case Studies from Health Canada Review: Comparative Bioavailability Studies for Chemical Drugs

  • US FDA:

    Validation of Recovery in Chromatographic Bioanalytical Method

  • UK MHRA:

    Bioanalytical Observations and Findings from Recent Inspections

  • US FDA:

    Regulatory Assessments for Internal Standard in Generic Drug Product Applications

  • Brazil ANVISA:

    Update on Large Molecule Bioanalysis in Brazil

  • Italy AIFA:

    Regulated Bioanalysis Impact in Clinical Research

ASK THE REGULATORS!

  • Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Health Canada and 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

  • US FDA:

    A Regulatory Update on Biomarker Qualification Program (BQP) & Biomarker Assay Validation (BAV)

  • Belgium FAMHP:

    Biomarkers in Oncology: A Regulatory Perspective

  • US FDA:

    Assay Comparability – A Regulators Perspective

  • EU EMA:

    Regulatory Developments in Vaccines Approval Landscape

  • US FDA:

    NGS and PCR Validation & Applications in Biomarker Development

  • US FDA:

    Use of NGS Technologies on Clinical Applications: A view from Regulatory Science

ASK THE REGULATORS!

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





Agenda at a Glance Agenda at a Glance