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    In-Vitro Diagnostic Testing

    IVD, or in-vitro diagnostics are tests done on sample like blood or tissue that were taken from the human body. They can be used to detect diseases or other conditions and to monitor a person's overall health to help cure, treat, or prevent diseases.

    Webinars

    • APR 07, 2016 | 7:30 AM
      Evidence Required by FDA for Establishing Clinical Validity
      Evidence Required by FDA for Establishing Clinical Validity
      In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests.  The legal bar passed by congress in...
      Speaker: Alberto Gutierrez, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2016
      2
      NOV 12, 2015 | 10:30 AM
      Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers: FDA perspective
      Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers:...
      Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used...
      Speaker: Doug Jeffery, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      2
      NOV 11, 2015 | 9:00 AM
      Keynote: FDA's Proposed Framework for Regulatory Oversight of Laboratory Developed Tests
      Keynote: FDA's Proposed Framework for Regulatory Oversight of...
      FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.  This use of “enforcement discretion” has been un...
      Speaker: Katherine (Katie) Serrano
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      2
      JUN 30, 2015 | 11:00 AM
      Webinar: Simplify Routine Workflows - Using LC-tandem MS for General Clinical Use
      Webinar: Simplify Routine Workflows - Using LC-tandem MS for General...
      Date: Tuesday, June 30th, 2015Time: 11:00AM PDT, 2:00PM EDT There is a growing interest of LC-tandem MS in clinical laboratories because this analytical technique can provide definitive ident...
      Speaker: Joseph Di Bussolo, PhD
      Sponsored By: Thermo Fisher Scientific, Thermo Fisher Scientific
      7
      MAY 30, 2014 | 9:00 AM
      Panel Discussion: Vaginitis/vaginosis: Diagnosis and workup using conventional and molecular tests. Dr's Bowman and Wang
      Panel Discussion: Vaginitis/vaginosis: Diagnosis and workup using...
      Vaginitis and vaginosis, including Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV), are extremely common conditions, consuming many healthcare resources and...
      Speaker: Cynthia Foss Bowman, MD and Guiqing Wang, MD, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
      79
      MAY 28, 2014 | 1:30 PM
      Legal and Regulatory Developments Affecting Molecular Testing
      Legal and Regulatory Developments Affecting Molecular Testing
      The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by...
      Speaker: Peter M Kazon, JD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
      14
      FEB 05, 2014 | 11:00 AM
      C.E. CREDITS
      The Future of Mouse Embryo Transfer: Achieving the 3Rs with the NSET Device
      The Future of Mouse Embryo Transfer: Achieving the 3Rs with the...
      Non-surgical transfer techniques for mouse embryos and sperm provide animal welfare benefits for assisted reproduction of mice. While surgical embryo transfer (ET) is an effective method for...
      Speaker: Barbara Stone, PhD
      Presented at: Laboratory Animal Sciences Virtual Event Series 2014
      39
      AUG 22, 2013 | 3:00 PM
      C.E. CREDITS
      Evaluation challenges and regulatory considerations for next-generation sequencing and other high throughput genomic technology based clinical applications
      Evaluation challenges and regulatory considerations for next-generation...
      The use of ultrahigh throughput diagnostic tests that determine genetic sequence variation to guide patient care is rapidly expanding, fueled by the enormous growth in sequencing platform dev...
      Speaker: Živana Težak, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2013
      282
      MAY 30, 2013 | 8:00 AM
      VITROS® Microslide Technologies / Assays
      VITROS® Microslide Technologies / Assays
      VITROS® Microslides utilize a layered, dry-slide technology that enables separate reaction domains such that each step can be optimized to provide excellent assay performance. Excellent preci...
      Speaker: John Backus, PhD
      Presented at: Clinical Diagnostics Virtual Event Series 2013
      51
    APR 07, 2016 | 7:30 AM
    Evidence Required by FDA for Establishing Clinical Validity
    Evidence Required by FDA for Establishing Clinical Validity
    In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests.  The legal bar passed by congress in...
    Speaker: Alberto Gutierrez, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2016
    2
    NOV 12, 2015 | 10:30 AM
    Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers: FDA perspective
    Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers:...
    Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used...
    Speaker: Doug Jeffery, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    2
    NOV 11, 2015 | 9:00 AM
    Keynote: FDA's Proposed Framework for Regulatory Oversight of Laboratory Developed Tests
    Keynote: FDA's Proposed Framework for Regulatory Oversight of...
    FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.  This use of “enforcement discretion” has been un...
    Speaker: Katherine (Katie) Serrano
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    2
    JUN 30, 2015 | 11:00 AM
    Webinar: Simplify Routine Workflows - Using LC-tandem MS for General Clinical Use
    Webinar: Simplify Routine Workflows - Using LC-tandem MS for General...
    Date: Tuesday, June 30th, 2015Time: 11:00AM PDT, 2:00PM EDT There is a growing interest of LC-tandem MS in clinical laboratories because this analytical technique can provide definitive ident...
    Speaker: Joseph Di Bussolo, PhD
    Sponsored By: Thermo Fisher Scientific, Thermo Fisher Scientific
    7
    MAY 30, 2014 | 9:00 AM
    Panel Discussion: Vaginitis/vaginosis: Diagnosis and workup using conventional and molecular tests. Dr's Bowman and Wang
    Panel Discussion: Vaginitis/vaginosis: Diagnosis and workup using...
    Vaginitis and vaginosis, including Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV), are extremely common conditions, consuming many healthcare resources and...
    Speaker: Cynthia Foss Bowman, MD and Guiqing Wang, MD, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
    79
     
     
  • MAY 28, 2014 | 1:30 PM
    Legal and Regulatory Developments Affecting Molecular Testing
    Legal and Regulatory Developments Affecting Molecular Testing
    The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by...
    Speaker: Peter M Kazon, JD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
    14
    FEB 05, 2014 | 11:00 AM
    C.E. CREDITS
    The Future of Mouse Embryo Transfer: Achieving the 3Rs with the NSET Device
    The Future of Mouse Embryo Transfer: Achieving the 3Rs with the...
    Non-surgical transfer techniques for mouse embryos and sperm provide animal welfare benefits for assisted reproduction of mice. While surgical embryo transfer (ET) is an effective method for...
    Speaker: Barbara Stone, PhD
    Presented at: Laboratory Animal Sciences Virtual Event Series 2014
    39
    AUG 22, 2013 | 3:00 PM
    C.E. CREDITS
    Evaluation challenges and regulatory considerations for next-generation sequencing and other high throughput genomic technology based clinical applications
    Evaluation challenges and regulatory considerations for next-generation...
    The use of ultrahigh throughput diagnostic tests that determine genetic sequence variation to guide patient care is rapidly expanding, fueled by the enormous growth in sequencing platform dev...
    Speaker: Živana Težak, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2013
    282
    MAY 30, 2013 | 8:00 AM
    VITROS® Microslide Technologies / Assays
    VITROS® Microslide Technologies / Assays
    VITROS® Microslides utilize a layered, dry-slide technology that enables separate reaction domains such that each step can be optimized to provide excellent assay performance. Excellent preci...
    Speaker: John Backus, PhD
    Presented at: Clinical Diagnostics Virtual Event Series 2013
    51
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