Join Intertek’s Pharmaceutical Services expert, Stephen Rundlett, as he covers the evolving world of biomarker discovery, technical qualification and validation using assay formats such as Ligand Binding Assay (LBA), Liquid Chromatography – Mass Spectrometry (LC-MS) and High-Resolution Accurate Mass Spectrometry (HRAMS), and approaches taken to ensure regulatory compliance.

During this webinar you will learn how:

  • Bioanalytical Guidance for Biomarkers differs from that performed under different regulatory environments such as Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP).
  • Intertek applies a fit-for-purpose regulatory approach to studies performed using LBA, LC-MS and HRAMS platforms.
  • Intertek approaches the process of biomarker discovery, analytical qualification and analytical validation to ensure regulatory compliance.

Our Expert: Stephen Rundlett, PhD, Associate Director, Biomarker Program, Intertek Pharmaceutical Services

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