Main Workshop DAY 2 - Wednesday April 3, 2019

"LCMS & LBA: Orthogonality/Complementarity & Common Topics DAY"

Day 2 Session List

Day 2A: LBA & LCMS Orthogonality/Complementarity
  • Session 1:

    LBA & LCMS Orthogonality/Complementarity: Combined Applications for Resolving Complex Issues, Fully Integrated Bioanalytical Lab, Approaches for Correlation of Target Levels, Assessing Tumor Microenvironment

  • Session 2:

    Panel Discussion on LBA & LCMS Orthogonality/Complementarity - Consensus for 2019 White Paper in Bioanalysis

Day 2B: ICH M10 BMV Draft Guideline - Common Topics Chromatography & LBA
  • Session 3:

    Harmonized Topics among US FDA, EU EMA, Health Canada, Japan MHLW, Unresolved Issues and On-going Industry/Regulators’ Discussions

  • Session 4:

    Panel Discussion on ICH M10 BMV Draft Guideline Common Topics - Provide official Recommendations to ICH

Day 2C: Regulators' Advice on Bioanalysis, BMV Guidance/Guidelines
  • Session 5:

    Latest Regulators’ inputs from US FDA, EU EMA, UK MHRA, France ANSM, Health Canada, Brazil ANVISA, and Japan MHLW on Bioanalysis, BMV Guidance/Guidelines

  • Session 6:

    Ask the Regulators! Traditional Interactive Panel Discussion with the Regulators on on Bioanalysis, BMV Guidance/Guidelines

Day 2D: Regulators' Advice on Immunogenicity Final Guidance and Biomarker Guidance/Papers
  • Session 7:

    Latest Regulators’ inputs from US FDA, EU EMA, Norwegian NoMA, UK MHRA, Health Canada, and Japan MHLW on Immunogenicity Final Guidance and Biomarker Guidance/Papers

  • Session 8:

    Ask the Regulators! Traditional Interactive Panel Discussion with the Regulators on on Immunogenicity Final Guidance and Biomarker Guidance/Papers

 

 

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