Submit Your Questions to Regulators

While the 13th WRIB will continues its well-established tradition to provide Novel Solutions in Drug Discovery/Development and promote Innovation in Method Development in Bioanalysis, Biomarkers and Immunogenicity, the 2019 edition is also setting the stage to discuss 4 recently released guidance important to the industry with a long list of participating regulators:

  • 2019 Draft ICH M10 BMV Guideline
  • 2019 Final FDA Immunogenicity Guidance
  • 2018 Draft FDA Biomarker Qualification Guidance
  • 2018 Final FDA BMV Guidance

If you have any questions regarding any of the guidance above, submit your questions (anonymously if you choose to) ahead of time so the regulators can be prepared to address your concerns during the 13th WRIB.

Please indicate which Guidance you have question(s) on: *

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