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    Clinical Evaluation

    Clinical Evaluation: is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.

    Webinars

    • NOV 08, 2018 | 9:00 AM
      Influenza 2018-2019: Are you ready?
      Influenza 2018-2019: Are you ready?
      DATE: November 8, 2018TIME:  9:00AM PDTAnnual epidemics of influenza place a substantial burden on the health of people in the United States. CDC estimates that influenza has...
      Speaker: Jay M. Lieberman, M.D.
      Sponsored By: Diasorin
      9
      OCT 25, 2018 | 10:30 AM
      Trash or Treasure: Optimizing Titration Electrodes and Consumables
      Trash or Treasure: Optimizing Titration Electrodes and Consumables
      Everyone that uses titration in their lab knows how simple and fast the technique can be.  However, uncertainty around when to replace electrodes creates confusion. Reagent quality, tubi...
      Speaker: Jessica McVay , Lori Spafford
      Presented at: Analytical Chemistry Virtual Event Series 2018
      Sponsored By: Metrohm USA
      1
      OCT 25, 2018 | 9:00 AM
      Advances in Hydrogen-Deuterium Exchange Mass Spectrometry That Can Improve Studies of Biosimilars and Membrane Protein Drug Targets
      Advances in Hydrogen-Deuterium Exchange Mass Spectrometry That...
      Hydrogen-deuterium exchange mass spectrometry (HDX-MS) has developed into a powerful tool for investigating biopharmaceuticals, protein interactions, and membrane protein dynamics. Since 2010...
      Speaker: Jeffrey Hudgens, PhD
      Presented at: Analytical Chemistry Virtual Event Series 2018
      2
      OCT 25, 2018 | 7:30 AM
      Analytical Approaches to Advance Alzheimer's Disease Research
      Analytical Approaches to Advance Alzheimer's Disease Research
      Alzheimer’s disease is becoming a public health crisis as the anticipated number of sufferers is expected to rise to 15 million in the next 30 years, at least in the US. These numbers a...
      Speaker: Rena Robinson, PhD
      Presented at: Analytical Chemistry Virtual Event Series 2018
      1
      OCT 24, 2018 | 9:00 AM
      Keynote Presentation: Solid Phase Microextraction: New Developments in Bioanalysis and Medical Applications
      Keynote Presentation: Solid Phase Microextraction: New Developments...
      Solid phase microextraction (SPME) is a versatile, non-exhaustive sample preparation tool that has been demonstrated to be well-suited for facile and effective analysis of a broad range of co...
      Speaker: Barbara Bojko, PhD , Janusz Pawliszyn, PhD, FCIC, FRSC
      Presented at: Analytical Chemistry Virtual Event Series 2018
      2
      OCT 12, 2018 | 8:00 AM
      Clinical Use of D-dimer in Venous Thromboembolism
      Clinical Use of D-dimer in Venous Thromboembolism
      The D-dimer can be a useful tool in the management of patients with suspected or established venous thromboembolism (VTE). One use is in the assessment of a patient who presents with symptoms...
      Speaker: Stephan Moll, MD
      Sponsored By: Diagnostica Stago, Inc.
      8 1
      OCT 11, 2018 | 9:00 AM
      Association of Biotin Ingestion with Performance of Hormone and Nonhormone Assays in Healthy Adults
      Association of Biotin Ingestion with Performance of Hormone and...
      High dose of biotin may interference with many routine clinical immunoassays and inaccurate results of some of the tests such as cardiac troponin has serious clinical complications. There is...
      Speaker: Danni Li, PhD, DABCC
      Presented at: Discover More; Your Virtual Resource
      Sponsored By: Diasorin
      12
      OCT 09, 2018 | 8:00 AM
      GMP Ancillary Materials for Cell and Gene Therapy Manufacturing: What to consider and when to make the switch
      GMP Ancillary Materials for Cell and Gene Therapy Manufacturing:...
      DATE: October 9, 2018TIME: 08:00am PDT, 11:00pm EDT Have you ever wondered what to consider when you are selecting ancillary materials for your cell therapy clinical research...
      Speaker: Kasey Kime , Eric Roos
      Sponsored By: Thermo Fisher Scientific/Gibco
      12
      SEP 26, 2018 | 1:30 PM
      Two-Dimensional and Three-Dimensional Cell Culture, Does Dimension Really Matter?
      Two-Dimensional and Three-Dimensional Cell Culture, Does Dimension...
      When looking to answer complex biological questions, using in vitro techniques, you want the model that best reflects the in vivo condition.  For decades two-dimensional cell culture has...
      Speaker: Carlemi Calitz, PhD
      Presented at: Cell Biology Virtual Event Series 2018
      2
      AUG 09, 2018 | 7:00 AM
      3D Cell Cultures and Tissue Clearing: A High Content Confocal Platform for the Complete 3D Characterization of Advanced Cell Models
      3D Cell Cultures and Tissue Clearing: A High Content Confocal...
      With the advent of cost effective culturing approaches, 3D cell culture models (3D-CCMs) have been rapidly adopted for drug discovery since they provide a more physiologically relevant micro-...
      Speaker: Michael Johnson, PhD
      Sponsored By: Thermo Fisher Scientific
      7
      JUN 21, 2018 | 12:00 PM
      Whole Genome Sequencing As A Valuable Clinical Tool For the Management of Cancer Patients
      Whole Genome Sequencing As A Valuable Clinical Tool For the Management...
      Advances in DNA sequencing, based upon massively parallel sequencing, has resulted in dramatic advances in DNA sequence output in the past few years. It is now possible to generate terrabases...
      Speaker: David Smith, PhD
      Presented at: Precision Medicine Virtual Event Series 2018
      1
      JUN 21, 2018 | 7:30 AM
      Keynote Presentation: Paving the Path Towards Precision Medicine in Inflammatory Bowel Diseases
      Keynote Presentation: Paving the Path Towards Precision Medicine...
      Crohn’s disease and ulcerative colitis also known as inflammatory bowel diseases or IBD, are characterized by chronic, recurrent inflammation of the gastrointestinal tract, which result...
      Speaker: Andres Hurtado-Lorenzo, PhD
      Presented at: Precision Medicine Virtual Event Series 2018
      1
      MAY 30, 2018 | 10:30 AM
      Inhibitors of NSD2 Discovered by High-Throughput Screening with a Nucleosome Substrate
      Inhibitors of NSD2 Discovered by High-Throughput Screening with...
      NSD2 catalyzes the mono- and di-methylation of the e-amine of lysine 36 from histone H3, utilizing the methyl donor S-adenosyl-L-methionine. Increased catalytic activity of NSD2, either by ov...
      Speaker: Nathan Coussens, PhD
      Presented at: Lab Automation Virtual Event Series 2018
      1
      MAY 24, 2018 | 9:30 AM
      Turning to a new dimension in cell culture for cancer research
      Turning to a new dimension in cell culture for cancer research
      DATE: May 24, 2018 TIME: 9:30PM PDT The current gold standard in in vitro pre-clinical cancer treatment screening remain cell lines,...
      Speaker: Carlemi Calitz, PhD
      Sponsored By: Thermo Fisher Scientific/Gibco
      14 2
      MAY 10, 2018 | 1:30 PM
      C.E. CREDITS
      Population Genomic Screening: The Alabama Genomic Health Initiative
      Population Genomic Screening: The Alabama Genomic Health Initiative
      As the costs of genomic analysis decline it becomes possible to offer widescale population genomic analysis to screen for genetic disorders.  The Alabama Genomic Health Initiative was es...
      Speaker: Bruce R. Korf, MD, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2018
      1
      MAY 09, 2018 | 7:30 AM
      C.E. CREDITS
      Keynote Presentation: Informing Clinical Interpretations of Structural Chromosome Rearrangements:  Implementing Evolving Knowledge from Chromatin Structure
      Keynote Presentation: Informing Clinical Interpretations of Structural...
      The arrangement of chromatin inside the nucleus has long been recognized as a key element in genomic stability and an active participant in transcriptional control. With the development and d...
      Speaker: Cynthia Morton, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2018
      3
      MAY 09, 2018 | 6:00 AM
      Genome in a Bottle: Developing Benchmark Sets for Structural Variants
      Genome in a Bottle: Developing Benchmark Sets for Structural Variants
      The Genome in a Bottle Consortium (GIAB) has characterized an Ashkenazi trio from the Personal Genome Project (NIST Reference Material 8392) with 12 short, long, and linked read sequencing an...
      Speaker: Justin Zook, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2018
      1
      APR 12, 2018 | 10:30 AM
      The Genome in 3D: A Clinical Biomarker Platform
      The Genome in 3D: A Clinical Biomarker Platform
      In genomics, as in life, you need to be in the right place at the right time, and you need integrity, to be credible. Since the availability of the human genome sequence, there's been an...
      Speaker: Kevin Little, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2018
      1
      APR 11, 2018 | 12:00 PM
      Emerging Trends: Cell Free (cf)DNA-Based Screening for Common Aneuploidies
      Emerging Trends: Cell Free (cf)DNA-Based Screening for Common...
      Screening for Down syndrome began with the question "How old will you be when you deliver?".  If the pregnant woman answered 35 years of age or older, she was offered amniocent...
      Speaker: Glenn Palomaki, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2018
      1
      MAR 29, 2018 | 1:30 PM
      Global Cannabis Regulation and Testing Standards
      Global Cannabis Regulation and Testing Standards
      For a plant that has been legal in some states for over 20 years, there has been an attitude that “cannabis never killed anyone.” While we don’t have the necessary rese...
      Speaker: Donald Land, PhD
      Presented at: Cannabis Sciences Virtual Event Series 2018
      4
      MAR 29, 2018 | 10:30 AM
      A Voyage Into the Captivating Realm of Cannabis Science and its Regulation
      A Voyage Into the Captivating Realm of Cannabis Science and its...
      The cannabis industry as a whole is under considerable scrutiny.  Finger-pointing and blame regarding inaccurate product labels run rampant.  Media outlets have often faulted the sk...
      Speaker: Jason Lupoi, PhD
      Presented at: Cannabis Sciences Virtual Event Series 2018
      1
      MAR 22, 2018 | 7:00 AM
      Emerging Diagnostic Strategies to Support C. difficile Infection Control
      Emerging Diagnostic Strategies to Support C. difficile Infection...
      DATE: March 22, 2018TIME: 07:00am PDT, 10:00am EDTClostridium difficile (C. diff) is a highly problematic healthcare-associated infection that is easily spread and often results in poor...
      Speaker: Lance Peterson, MD, FASCP, FIDSA, FAAM, FSHEA
      Sponsored By: Roche Diagnostics
      8
      MAR 21, 2018 | 8:00 AM
      Powering multi-omic translational studies with mass cytometry: characterizing the molecular pacemakers of pregnancy
      Powering multi-omic translational studies with mass cytometry:...
      DATE: March 21, 2018TIME: 8:00AM PST, 11:00AM ESTMass cytometry, or cytometry by time-of-flight (the basis of the CyTOF® system), enables quantification of the abundance and fu...
      Speaker: Brice Gaudilliere MD, PhD , Nima Aghaeepour, PhD
      Sponsored By: Standard BioTools
      7
      FEB 22, 2018 | 9:00 AM
      Clinical Implementation of Pharmacogenomics: Delivering Genomics to the Bedside
      Clinical Implementation of Pharmacogenomics: Delivering Genomics...
      Pharmacogenomics has emerged as an early use case of precision medicine.  Delivering this new clinical data to clinicians in a ready to use format can be challenging.  This talk wil...
      Speaker: Mark Dunnenberger, PharmD
      Presented at: Drug Discovery Virtual Event Series 2018
      1
    NOV 08, 2018 | 9:00 AM
    Influenza 2018-2019: Are you ready?
    Influenza 2018-2019: Are you ready?
    DATE: November 8, 2018TIME:  9:00AM PDTAnnual epidemics of influenza place a substantial burden on the health of people in the United States. CDC estimates that influenza has...
    Speaker: Jay M. Lieberman, M.D.
    Sponsored By: Diasorin
    9
    OCT 25, 2018 | 10:30 AM
    Trash or Treasure: Optimizing Titration Electrodes and Consumables
    Trash or Treasure: Optimizing Titration Electrodes and Consumables
    Everyone that uses titration in their lab knows how simple and fast the technique can be.  However, uncertainty around when to replace electrodes creates confusion. Reagent quality, tubi...
    Speaker: Jessica McVay , Lori Spafford
    Presented at: Analytical Chemistry Virtual Event Series 2018
    Sponsored By: Metrohm USA
    1
    OCT 25, 2018 | 9:00 AM
    Advances in Hydrogen-Deuterium Exchange Mass Spectrometry That Can Improve Studies of Biosimilars and Membrane Protein Drug Targets
    Advances in Hydrogen-Deuterium Exchange Mass Spectrometry That...
    Hydrogen-deuterium exchange mass spectrometry (HDX-MS) has developed into a powerful tool for investigating biopharmaceuticals, protein interactions, and membrane protein dynamics. Since 2010...
    Speaker: Jeffrey Hudgens, PhD
    Presented at: Analytical Chemistry Virtual Event Series 2018
    2
    OCT 25, 2018 | 7:30 AM
    Analytical Approaches to Advance Alzheimer's Disease Research
    Analytical Approaches to Advance Alzheimer's Disease Research
    Alzheimer’s disease is becoming a public health crisis as the anticipated number of sufferers is expected to rise to 15 million in the next 30 years, at least in the US. These numbers a...
    Speaker: Rena Robinson, PhD
    Presented at: Analytical Chemistry Virtual Event Series 2018
    1
    OCT 24, 2018 | 9:00 AM
    Keynote Presentation: Solid Phase Microextraction: New Developments in Bioanalysis and Medical Applications
    Keynote Presentation: Solid Phase Microextraction: New Developments...
    Solid phase microextraction (SPME) is a versatile, non-exhaustive sample preparation tool that has been demonstrated to be well-suited for facile and effective analysis of a broad range of co...
    Speaker: Barbara Bojko, PhD , Janusz Pawliszyn, PhD, FCIC, FRSC
    Presented at: Analytical Chemistry Virtual Event Series 2018
    2
     
     
  • OCT 12, 2018 | 8:00 AM
    Clinical Use of D-dimer in Venous Thromboembolism
    Clinical Use of D-dimer in Venous Thromboembolism
    The D-dimer can be a useful tool in the management of patients with suspected or established venous thromboembolism (VTE). One use is in the assessment of a patient who presents with symptoms...
    Speaker: Stephan Moll, MD
    Sponsored By: Diagnostica Stago, Inc.
    8 1
    OCT 11, 2018 | 9:00 AM
    Association of Biotin Ingestion with Performance of Hormone and Nonhormone Assays in Healthy Adults
    Association of Biotin Ingestion with Performance of Hormone and...
    High dose of biotin may interference with many routine clinical immunoassays and inaccurate results of some of the tests such as cardiac troponin has serious clinical complications. There is...
    Speaker: Danni Li, PhD, DABCC
    Presented at: Discover More; Your Virtual Resource
    Sponsored By: Diasorin
    12
    OCT 09, 2018 | 8:00 AM
    GMP Ancillary Materials for Cell and Gene Therapy Manufacturing: What to consider and when to make the switch
    GMP Ancillary Materials for Cell and Gene Therapy Manufacturing:...
    DATE: October 9, 2018TIME: 08:00am PDT, 11:00pm EDT Have you ever wondered what to consider when you are selecting ancillary materials for your cell therapy clinical research...
    Speaker: Kasey Kime , Eric Roos
    Sponsored By: Thermo Fisher Scientific/Gibco
    12
    SEP 26, 2018 | 1:30 PM
    Two-Dimensional and Three-Dimensional Cell Culture, Does Dimension Really Matter?
    Two-Dimensional and Three-Dimensional Cell Culture, Does Dimension...
    When looking to answer complex biological questions, using in vitro techniques, you want the model that best reflects the in vivo condition.  For decades two-dimensional cell culture has...
    Speaker: Carlemi Calitz, PhD
    Presented at: Cell Biology Virtual Event Series 2018
    2
    AUG 09, 2018 | 7:00 AM
    3D Cell Cultures and Tissue Clearing: A High Content Confocal Platform for the Complete 3D Characterization of Advanced Cell Models
    3D Cell Cultures and Tissue Clearing: A High Content Confocal...
    With the advent of cost effective culturing approaches, 3D cell culture models (3D-CCMs) have been rapidly adopted for drug discovery since they provide a more physiologically relevant micro-...
    Speaker: Michael Johnson, PhD
    Sponsored By: Thermo Fisher Scientific
    7
     
     
  • JUN 21, 2018 | 12:00 PM
    Whole Genome Sequencing As A Valuable Clinical Tool For the Management of Cancer Patients
    Whole Genome Sequencing As A Valuable Clinical Tool For the Management...
    Advances in DNA sequencing, based upon massively parallel sequencing, has resulted in dramatic advances in DNA sequence output in the past few years. It is now possible to generate terrabases...
    Speaker: David Smith, PhD
    Presented at: Precision Medicine Virtual Event Series 2018
    1
    JUN 21, 2018 | 7:30 AM
    Keynote Presentation: Paving the Path Towards Precision Medicine in Inflammatory Bowel Diseases
    Keynote Presentation: Paving the Path Towards Precision Medicine...
    Crohn’s disease and ulcerative colitis also known as inflammatory bowel diseases or IBD, are characterized by chronic, recurrent inflammation of the gastrointestinal tract, which result...
    Speaker: Andres Hurtado-Lorenzo, PhD
    Presented at: Precision Medicine Virtual Event Series 2018
    1
    MAY 30, 2018 | 10:30 AM
    Inhibitors of NSD2 Discovered by High-Throughput Screening with a Nucleosome Substrate
    Inhibitors of NSD2 Discovered by High-Throughput Screening with...
    NSD2 catalyzes the mono- and di-methylation of the e-amine of lysine 36 from histone H3, utilizing the methyl donor S-adenosyl-L-methionine. Increased catalytic activity of NSD2, either by ov...
    Speaker: Nathan Coussens, PhD
    Presented at: Lab Automation Virtual Event Series 2018
    1
    MAY 24, 2018 | 9:30 AM
    Turning to a new dimension in cell culture for cancer research
    Turning to a new dimension in cell culture for cancer research
    DATE: May 24, 2018 TIME: 9:30PM PDT The current gold standard in in vitro pre-clinical cancer treatment screening remain cell lines,...
    Speaker: Carlemi Calitz, PhD
    Sponsored By: Thermo Fisher Scientific/Gibco
    14 2
    MAY 10, 2018 | 1:30 PM
    C.E. CREDITS
    Population Genomic Screening: The Alabama Genomic Health Initiative
    Population Genomic Screening: The Alabama Genomic Health Initiative
    As the costs of genomic analysis decline it becomes possible to offer widescale population genomic analysis to screen for genetic disorders.  The Alabama Genomic Health Initiative was es...
    Speaker: Bruce R. Korf, MD, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2018
    1
     
     
  • MAY 09, 2018 | 7:30 AM
    C.E. CREDITS
    Keynote Presentation: Informing Clinical Interpretations of Structural Chromosome Rearrangements:  Implementing Evolving Knowledge from Chromatin Structure
    Keynote Presentation: Informing Clinical Interpretations of Structural...
    The arrangement of chromatin inside the nucleus has long been recognized as a key element in genomic stability and an active participant in transcriptional control. With the development and d...
    Speaker: Cynthia Morton, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2018
    3
    MAY 09, 2018 | 6:00 AM
    Genome in a Bottle: Developing Benchmark Sets for Structural Variants
    Genome in a Bottle: Developing Benchmark Sets for Structural Variants
    The Genome in a Bottle Consortium (GIAB) has characterized an Ashkenazi trio from the Personal Genome Project (NIST Reference Material 8392) with 12 short, long, and linked read sequencing an...
    Speaker: Justin Zook, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2018
    1
    APR 12, 2018 | 10:30 AM
    The Genome in 3D: A Clinical Biomarker Platform
    The Genome in 3D: A Clinical Biomarker Platform
    In genomics, as in life, you need to be in the right place at the right time, and you need integrity, to be credible. Since the availability of the human genome sequence, there's been an...
    Speaker: Kevin Little, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2018
    1
    APR 11, 2018 | 12:00 PM
    Emerging Trends: Cell Free (cf)DNA-Based Screening for Common Aneuploidies
    Emerging Trends: Cell Free (cf)DNA-Based Screening for Common...
    Screening for Down syndrome began with the question "How old will you be when you deliver?".  If the pregnant woman answered 35 years of age or older, she was offered amniocent...
    Speaker: Glenn Palomaki, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2018
    1
    MAR 29, 2018 | 1:30 PM
    Global Cannabis Regulation and Testing Standards
    Global Cannabis Regulation and Testing Standards
    For a plant that has been legal in some states for over 20 years, there has been an attitude that “cannabis never killed anyone.” While we don’t have the necessary rese...
    Speaker: Donald Land, PhD
    Presented at: Cannabis Sciences Virtual Event Series 2018
    4
     
     
  • MAR 29, 2018 | 10:30 AM
    A Voyage Into the Captivating Realm of Cannabis Science and its Regulation
    A Voyage Into the Captivating Realm of Cannabis Science and its...
    The cannabis industry as a whole is under considerable scrutiny.  Finger-pointing and blame regarding inaccurate product labels run rampant.  Media outlets have often faulted the sk...
    Speaker: Jason Lupoi, PhD
    Presented at: Cannabis Sciences Virtual Event Series 2018
    1
    MAR 22, 2018 | 7:00 AM
    Emerging Diagnostic Strategies to Support C. difficile Infection Control
    Emerging Diagnostic Strategies to Support C. difficile Infection...
    DATE: March 22, 2018TIME: 07:00am PDT, 10:00am EDTClostridium difficile (C. diff) is a highly problematic healthcare-associated infection that is easily spread and often results in poor...
    Speaker: Lance Peterson, MD, FASCP, FIDSA, FAAM, FSHEA
    Sponsored By: Roche Diagnostics
    8
    MAR 21, 2018 | 8:00 AM
    Powering multi-omic translational studies with mass cytometry: characterizing the molecular pacemakers of pregnancy
    Powering multi-omic translational studies with mass cytometry:...
    DATE: March 21, 2018TIME: 8:00AM PST, 11:00AM ESTMass cytometry, or cytometry by time-of-flight (the basis of the CyTOF® system), enables quantification of the abundance and fu...
    Speaker: Brice Gaudilliere MD, PhD , Nima Aghaeepour, PhD
    Sponsored By: Standard BioTools
    7
    FEB 22, 2018 | 9:00 AM
    Clinical Implementation of Pharmacogenomics: Delivering Genomics to the Bedside
    Clinical Implementation of Pharmacogenomics: Delivering Genomics...
    Pharmacogenomics has emerged as an early use case of precision medicine.  Delivering this new clinical data to clinicians in a ready to use format can be challenging.  This talk wil...
    Speaker: Mark Dunnenberger, PharmD
    Presented at: Drug Discovery Virtual Event Series 2018
    1
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