Specialized Workshop F1Friday September 30, 2022: 7am - 5:30pm - Roundtable Discussion & Lecture List

"ICH M10 BMV Guidance & Global Harmonization Day"

Consideration on ICH M10 Adoption, Transition and Interpretation; Interactive Industry/Regulators' Discussions on Audits/Inspections/Submissions Outcomes; Recent Issues in Regulated Bioanalysis for Small & Large Molecules; Gap Analysis on New Controversial Issues; Evolving Regulatory Standards for Chromatographic & Ligand Binding Assays

Part 1: Impact of Global Harmonization on Regulated Bioanalysis

  • Lecture 1:

    Importance of Cross Validation in Regulated Bioanalysis - Understanding Current Approaches and Pitfalls: Are there more Statistically Based Approaches to Evaluate?

  • Lecture 2:

    Method Cross Validation between Labs in China and Labs outside China: What it is possible and what it is impossible

  • Lecture 3:

    Patient Centric Sampling Implementation in Regulated Bioanalysis, De-centralized Global trials, at-home Blood Collection for PK Bioanalysis, Assay Bridging and Regulatory Acceptance

  • Lecture 4:

    Harmonization of Certificate of Analysis (CoA) Content & Reference Standard Materials (RSMs) Management in Regulated Bioanalysis: Importance of having International and Well-characterized RSMs for better Quality Data

Part 2: Common Mass Spectrometry and Ligand-binding Assays Issues

  • Lecture 5:

    The 3 Rs in Preclinical Regulated Bioanalysis: Do the current BMV Guidance/Guidelines allow to use of human plasma to dilute mice/rats plasma and reduce animals?

  • Lecture 6:

    Regulated Bioanalysis of Tissues & Secondary Matrices: Full, Partial, or better Fit for Purpose Validation?

  • Lecture 7:

    Stability Issues in Regulated Bioanalysis – Above ULOQ Stability, Additive exposure, Stability data collected in another facility, Incurred Sample Stability (ISS) and

  • Lecture 8:

    Using Novel/Alternative Technologies in Regulated Bioanalysis: Is it possible to use LBA Emerging Technologies (ET) for Regulatory Submissions? Are Hybrid Assays (IA-MS) still considered “Novel/Alternative Technologies” after over a decade of use/application?

  • Lecture 9:

    Endogenous Compounds Validation in Regulated Bioanalysis: What have we learned from ICH M10 Draft BMV Guidance Section 7.1. for both Chromatographic & Ligand-binding Assay?

Part 3: LBA Unique Challenges

  • Lecture 10:

    LBA Single Well Analysis (Singlicate) a Decade of Discussions in Regulated Bioanalysis – Where do we stand? Why are many companies not adopting it yet?

  • Lecture 11:

    How to Address the Change of the Critical Reagents in Regulated Bioanalysis: “KISS - Keep It Simple & Straightforward”

  • Lecture 12:

    Application of Automated PK LBA to overcome low sensitivity/interference and LBA Carryover Assessment in Regulated Bioanalysis

  • Lecture 13:

    Current Strategies for using Commercial, RUO & Diagnostic LBA Kits in Regulated Bioanalysis – What extra validation is needed?

Part 4: White Paper in Bioanalysis

  • 2022 White Paper on BMV Guidance & Global Harmonization:

    Consensus & Conclusions on BMV Guidance & Global Harmonization for 2022 White Paper

Finale: ASK THE REGULATORS!

  • Panel Discussion with All the Regulators:

    Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, Health Canada, Japan MHLW, Brazil ANVISA, WHO
    Ask the Regulators any Questions You Have on BMV Guidance & Global Harmonization and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes





Agenda at a Glance Agenda at a Glance