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Bioanalytics
Symposium

Symposium: Changing Landscape of Regulated Bioanalysis

Monday, November 10, 2025
9:00 AM - 11:00 AM CT
Location:221 AB

Bioanalytics

Presentations:

  • 9:00 AM - 9:30 AM CT
    Remembering the Bioanalytical Lessons Learned from Regulatory Submissions

    Speaker: Chongwoo Yu, Ph.D. – US Food and Drug Administration

  • 9:30 AM - 10:00 AM CT
    In vitro Bioequivalence - Trends in Regulatory Review and Inspections

    Speaker: Tahseen Mirza, Ph.D., MBA – US Food and Drug Administration

  • 10:00 AM - 10:30 AM CT
    Regulated Bioanalysis in China, a 15-Year Retrospective

    Speaker: Eric J. Woolf, PhD, FAAPS (he/him/his) – Beyond M10 Bioanalytical Consulting

  • 10:30 AM - 11:00 AM CT
    Immunogenicity Assessment: Can We Harmonize Immunogenicity Assays?

    Speaker: Gregor Jordan, M.Eng. – Roche Diagnostics GmbH