Training Session M2 - Monday April 1, 2019, 7am to 5:30pm

"IMPLEMENTATION of 2018 FDA BMV Final Guidance LCMS & LBA: Regulatory Inputs, Inspections Outcomes/Observations and Industry Experiences"

Lessons Learned from Case Studies in Small Molecules & Biotherapeutics

This full-day training session is organized by Dr. Brian Booth (US FDA) and it is focused on IMPLEMENTATION of the 2018 FDA BMV Guidance after a year from its issuance.

The speakers are opinion leaders from both the FDA (Reviewers and Inspectors) and Pharmas/CROs. Regulators will provide feedbacks on submitted studies and Inspections/audits outcomes based on the new Guidance. The Industry speakers will show how they have successfully implemented their SOPs to be in compliance with the new Guidance and avoid observations and 483s.

A list of 11 major topics/issues will be presented (see below), followed by panel discussions on each topic with the FDA regulators. Note: the topic list is preliminary, and subject to change.

Common topics Chromatographic & Ligand Binding Assays
  • Topic 1:

    What needs to be included in Synopsis of Method Development

  • Topic 2:

    Stability Evaluation of Higher Concentration QCs (>ULOQ)

  • Topic 3:

    Freshly Prepared Calibrators & QCs during Validation and Use of Frozen QC from Expired Stock Solution

  • Topic 4:

    Freshly Made Stock Solution for Stability and Use of Stock Solution from Expired Reference Standard

  • Topic 5:

    Stability of the analyte in the presence of other co-medications SM and/or Biotherapeutics

  • Topic 6:

    “Sample management and handling” impact on bioanalytical laboratory procedures

Chromatographic Assays
  • Topic 7:

    Reporting of Re-integrated Chromatograms & Study Report Re-injected runs with Results

  • Topic 8:

    Small Molecules Endogenous Molecules/Biomarkers

Ligand Binding Assays
  • Topic 9:

    Calibration Curve: "Anchor points should not be included in the curve fit”

  • Topic 10:

    Specificity: "Potential interfering materials should be added to calibration curves in buffer”

  • Topic 11:

    Dilution linearity: "5 replicates per dilution factor"

 

 

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