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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

    • MAY 04, 2016 | 8:00 AM
      Transient Expression: High Cell Density Culture for Increased Protein Production
      Transient Expression: High Cell Density Culture for Increased...
      The talk will focus on the recent advances in transient protein production using high cell density culture e.g. ExpiCHO, Expi293 for supporting pre-clinical and clinical studies including rob...
      Speaker: Puneet Khandelwal, PhD
      Presented at: 2016 Gibco ExpressionWorld
      2
      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
      APR 06, 2016 | 1:30 PM
      The application of molecular diagnostics to stained cytology smears
      The application of molecular diagnostics to stained cytology smears
      Detection of mutational alterations is important for guiding treatment decisions of lung non-small cell carcinomas and thyroid nodules with atypical cytologic findings. Inoperable lung tumors...
      Speaker: Maja Oktay, MD, PhD , Sumanta Goswami, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2016
      2
      APR 06, 2016 | 1:30 PM
      Validation and Implementation of Whole-Exome Sequencing to Guide Precision Cancer Care
      Validation and Implementation of Whole-Exome Sequencing to Guide...
      Cancer remains the second leading cause of death in the United States.  Most tumors arise from a myriad of genetic changes that dysregulate cell growth and prompt survival.  Ident...
      Speaker: Hanna Rennert, PhD, F.A.C.M.G
      Presented at: Molecular Diagnostics Virtual Event Series 2016
      4
      MAR 22, 2016 | 12:45 PM
      Turnkey resources: The Genetics Tool Kit
      Turnkey resources: The Genetics Tool Kit
      Genomic Medicine is an incredibly fast moving field awash in information. Successful practice requires ongoing access to authoritative and regularly-updated, yet focused resources for both pr...
      Speaker: Jean Jenkins, PhD, RN, FAAN
      Presented at: GENETICS IN YOUR CLINIC: WHAT YOU CAN AND SHOULD DO NOW
      2
      MAR 22, 2016 | 11:30 AM
      Tu nuevo mejor amigo: Tu relación con el laboratorio de genética
      Tu nuevo mejor amigo: Tu relación con el laboratorio de genética
      Esta sesión le brindara ejemplos de estudios genéticos que son frecuentemente solicitados y que información pueden brindar al medico y al paciente. Los conferencistas ex...
      Speaker: Carlos Bacino, MD
      Presented at: GENETICS IN YOUR CLINIC: WHAT YOU CAN AND SHOULD DO NOW
      2
      MAR 22, 2016 | 9:30 AM
      Tales from the Clinic
      Tales from the Clinic
      Medical genetics is a specialty of medicine that encompasses patients at all ages (prenatal, pediatric, adult), as well as all organ systems. As the genetic causes of more diseases have been ...
      Speaker: Fuki Hisama, MD, FACMG, FAAN , Eric Konnick, MD, MS , Laura Amendola, MS CGC
      Presented at: GENETICS IN YOUR CLINIC: WHAT YOU CAN AND SHOULD DO NOW
      3
      MAR 17, 2016 | 9:00 AM
      Featured Speaker - Preventive Strategies in Emerging Mental Disorders in Young People:  Clinical Staging and Translational Research
      Featured Speaker - Preventive Strategies in Emerging Mental Disorders...
      A key goal in psychiatry is to build new diagnostic, therapeutic and translational tools and capacity to reduce the impact of emerging mental disorders in young people on survival, distress,...
      Speaker: Patrick McGorry, MD, PhD, FRCP, FRANZCP
      Presented at: Neuroscience Virtual Event Series 2016
      3
      MAR 16, 2016 | 9:00 AM
      Featured Speaker - Uncertainty, choice and dopamine
      Featured Speaker - Uncertainty, choice and dopamine
      We routinely face decisions requiring evaluation and choice of different actions may or may not yield different types of rewards. These situations trigger competitive decision biases that ref...
      Speaker: Stan Floresco, PhD
      Presented at: Neuroscience Virtual Event Series 2016
      2
      FEB 24, 2016 | 5:00 AM
      How Personalised Healthcare is transforming drug development
      How Personalised Healthcare is transforming drug development
      Personalised Healthcare is essential to AstraZeneca’s approach to drug development and is adopted by more than 80% of drug products in clinical development. Selection of the right patie...
      Speaker: Ruth March, PhD
      Presented at: Precision Medicine Virtual Event Series 2016
      2
      FEB 03, 2016 | 12:00 PM
      Panel: How should we conduct and assess teaching and training to optimize animal handling?
      Panel: How should we conduct and assess teaching and training...
      The use of laboratory animals requires education and training of persons who are to design and/or perform animal experiments. It is essential for these persons to practice various procedures...
      Speaker: Klas Abelson, PhD , Jeffrey Everitt, DVM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      3
      FEB 03, 2016 | 12:00 PM
      Evaluating the results of animal studies by means of Meta Analysis
      Evaluating the results of animal studies by means of Meta Analysis
      Animal studies still play a crucial role in research aimed at improving human health care. When performing animal studies, the results and their interpretation are not always straightforward....
      Speaker: Carlijn Hooijmans, PhD
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      7
      FEB 03, 2016 | 10:30 AM
      The Power of Nesting
      The Power of Nesting
      Is your facility providing relevant nesting material or are you just checking off a box?  This presentation will discuss the importance of nesting for rodents, their behaviors, and today...
      Speaker: Andrea Gay
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      5
      FEB 03, 2016 | 6:00 AM
      Creating the Right Animal Program to Facilitate Quality Animal Studies. The AAALAC International Perspective
      Creating the Right Animal Program to Facilitate Quality Animal...
      Quality animal research is based on quality animal care and use. This is achieved by coordinating several key personnel and activities, and implementing appropriate animal care and use proced...
      Speaker: Javier Guillen, DVM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      3
      JAN 26, 2016 | 8:00 AM
      WEBINAR: Concordance of PTEN gene status in circulating tumor cells and tumor tissue from mCRPC patients
      WEBINAR: Concordance of PTEN gene status in circulating tumor...
      DATE: January 26th, 2016 TIME: 8am pacific, 11am eastern PTEN gene loss occurs frequently in castration-resistant prostate cancer (CRPC) and may drive progression through activation of th...
      Speaker: Edith Szafer-Glusman, PhD
      Sponsored By: Epic Sciences, Epic Sciences
      9
      JAN 20, 2016 | 8:00 AM
      Extracellular Vesicle Detection and Analysis via Flow Cytometry
      Extracellular Vesicle Detection and Analysis via Flow Cytometry
      Over the past decade, there has been a rapid growth in studies of secreted membrane vesicles, collectively called extracellular vesicles (EVs). (1) The release of EVs has been reported in the...
      Speaker: Vasilis Toxavidis , John Tigges
      Presented at: Beckman Coulter Life Sciences Virtual Trade Show
      Sponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life Sciences
      7 2
      JAN 12, 2016 | 8:00 AM
      WEBINAR: Combined Use of Multiple Particle Characterization Technologies to Evaluate Targeted Liposomal Formulations: Implications for General Nanoparticle Development
      WEBINAR: Combined Use of Multiple Particle Characterization Technologies...
      January 12, 2016, 8:00am PT, 11:00am ET, 3:00pm GMT Targeted nanoparticle applications have become a major focus of translational development of both diagnostics and therapeutics for clini...
      Speaker: Melvin Klegerman, PhD
      Presented at: Beckman Coulter Life Sciences Virtual Trade Show
      Sponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life Sciences
      11 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 12, 2015 | 9:00 AM
      Introducing an ancestrally diverse whole genome data set for select cohort and control research applications
      Introducing an ancestrally diverse whole genome data set for select...
      Introduction and adoption of whole-genome sequencing has enabled new methods of investigation in the quest for answers in diagnostic odyssey cases as well as in the broader study of genetic d...
      Speaker: Benjamin Solomon, MD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      3
      NOV 12, 2015 | 7:30 AM
      Keynote: Reconceptualizing Genital Herpes Diagnosis and Management
      Keynote: Reconceptualizing Genital Herpes Diagnosis and Management
      As one of the nation's most prevalent sexually transmitted infections, genital herpes represents a diagnostic and therapeutic challenge to clinicians, laboratorians and the patients they...
      Speaker: Edward Hook, III, MD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      2 1
      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
      NOV 03, 2015 | 8:00 AM
      WEBINAR: Health economic value of calprotectin testing: A gastroenterologist's perspective
      WEBINAR: Health economic value of calprotectin testing: A gastroenterologist's...
      FREE to register and attend! •    Patients presenting with persistent abdominal pain and diarrhea are common in clinical practice. Evaluation of these patients, assumin...
      Speaker: KT Park, MD, MS
      Sponsored By: Inova Diagnostics, Inova Diagnostics
      13 2
      OCT 01, 2015 | 9:00 AM
      RNA-editing in melanoma - Case for a sensitive analysis and interpretation platform for the resolution of a diverse molecular process and likely pathogenic variants
      RNA-editing in melanoma - Case for a sensitive analysis and interpretation...
      Of special interest in a clinical setting is the identification and interpretation of somatic variants from the DNA of a tumor/normal matched pair. Studies have shown that a large proportion...
      Speaker: Anika Joecker, PhD
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2015
      2
      SEP 30, 2015 | 9:00 AM
      Inventing Active Surveillance version 2.0
      Inventing Active Surveillance version 2.0
      The burgeoning area of molecular risk assessment (gene expression profiling and/or proteomic tests) in the diagnosis and treatment of prostate cancer is rapidly illuminating how clinicians mi...
      Speaker: Eric Klein, MD
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2015
      2
    MAY 04, 2016 | 8:00 AM
    Transient Expression: High Cell Density Culture for Increased Protein Production
    Transient Expression: High Cell Density Culture for Increased...
    The talk will focus on the recent advances in transient protein production using high cell density culture e.g. ExpiCHO, Expi293 for supporting pre-clinical and clinical studies including rob...
    Speaker: Puneet Khandelwal, PhD
    Presented at: 2016 Gibco ExpressionWorld
    2
    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
    APR 06, 2016 | 1:30 PM
    The application of molecular diagnostics to stained cytology smears
    The application of molecular diagnostics to stained cytology smears
    Detection of mutational alterations is important for guiding treatment decisions of lung non-small cell carcinomas and thyroid nodules with atypical cytologic findings. Inoperable lung tumors...
    Speaker: Maja Oktay, MD, PhD , Sumanta Goswami, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2016
    2
    APR 06, 2016 | 1:30 PM
    Validation and Implementation of Whole-Exome Sequencing to Guide Precision Cancer Care
    Validation and Implementation of Whole-Exome Sequencing to Guide...
    Cancer remains the second leading cause of death in the United States.  Most tumors arise from a myriad of genetic changes that dysregulate cell growth and prompt survival.  Ident...
    Speaker: Hanna Rennert, PhD, F.A.C.M.G
    Presented at: Molecular Diagnostics Virtual Event Series 2016
    4
    MAR 22, 2016 | 12:45 PM
    Turnkey resources: The Genetics Tool Kit
    Turnkey resources: The Genetics Tool Kit
    Genomic Medicine is an incredibly fast moving field awash in information. Successful practice requires ongoing access to authoritative and regularly-updated, yet focused resources for both pr...
    Speaker: Jean Jenkins, PhD, RN, FAAN
    Presented at: GENETICS IN YOUR CLINIC: WHAT YOU CAN AND SHOULD DO NOW
    2
     
     
  • MAR 22, 2016 | 11:30 AM
    Tu nuevo mejor amigo: Tu relación con el laboratorio de genética
    Tu nuevo mejor amigo: Tu relación con el laboratorio de genética
    Esta sesión le brindara ejemplos de estudios genéticos que son frecuentemente solicitados y que información pueden brindar al medico y al paciente. Los conferencistas ex...
    Speaker: Carlos Bacino, MD
    Presented at: GENETICS IN YOUR CLINIC: WHAT YOU CAN AND SHOULD DO NOW
    2
    MAR 22, 2016 | 9:30 AM
    Tales from the Clinic
    Tales from the Clinic
    Medical genetics is a specialty of medicine that encompasses patients at all ages (prenatal, pediatric, adult), as well as all organ systems. As the genetic causes of more diseases have been ...
    Speaker: Fuki Hisama, MD, FACMG, FAAN , Eric Konnick, MD, MS , Laura Amendola, MS CGC
    Presented at: GENETICS IN YOUR CLINIC: WHAT YOU CAN AND SHOULD DO NOW
    3
    MAR 17, 2016 | 9:00 AM
    Featured Speaker - Preventive Strategies in Emerging Mental Disorders in Young People:  Clinical Staging and Translational Research
    Featured Speaker - Preventive Strategies in Emerging Mental Disorders...
    A key goal in psychiatry is to build new diagnostic, therapeutic and translational tools and capacity to reduce the impact of emerging mental disorders in young people on survival, distress,...
    Speaker: Patrick McGorry, MD, PhD, FRCP, FRANZCP
    Presented at: Neuroscience Virtual Event Series 2016
    3
    MAR 16, 2016 | 9:00 AM
    Featured Speaker - Uncertainty, choice and dopamine
    Featured Speaker - Uncertainty, choice and dopamine
    We routinely face decisions requiring evaluation and choice of different actions may or may not yield different types of rewards. These situations trigger competitive decision biases that ref...
    Speaker: Stan Floresco, PhD
    Presented at: Neuroscience Virtual Event Series 2016
    2
    FEB 24, 2016 | 5:00 AM
    How Personalised Healthcare is transforming drug development
    How Personalised Healthcare is transforming drug development
    Personalised Healthcare is essential to AstraZeneca’s approach to drug development and is adopted by more than 80% of drug products in clinical development. Selection of the right patie...
    Speaker: Ruth March, PhD
    Presented at: Precision Medicine Virtual Event Series 2016
    2
     
     
  • FEB 03, 2016 | 12:00 PM
    Panel: How should we conduct and assess teaching and training to optimize animal handling?
    Panel: How should we conduct and assess teaching and training...
    The use of laboratory animals requires education and training of persons who are to design and/or perform animal experiments. It is essential for these persons to practice various procedures...
    Speaker: Klas Abelson, PhD , Jeffrey Everitt, DVM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    3
    FEB 03, 2016 | 12:00 PM
    Evaluating the results of animal studies by means of Meta Analysis
    Evaluating the results of animal studies by means of Meta Analysis
    Animal studies still play a crucial role in research aimed at improving human health care. When performing animal studies, the results and their interpretation are not always straightforward....
    Speaker: Carlijn Hooijmans, PhD
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    7
    FEB 03, 2016 | 10:30 AM
    The Power of Nesting
    The Power of Nesting
    Is your facility providing relevant nesting material or are you just checking off a box?  This presentation will discuss the importance of nesting for rodents, their behaviors, and today...
    Speaker: Andrea Gay
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    5
    FEB 03, 2016 | 6:00 AM
    Creating the Right Animal Program to Facilitate Quality Animal Studies. The AAALAC International Perspective
    Creating the Right Animal Program to Facilitate Quality Animal...
    Quality animal research is based on quality animal care and use. This is achieved by coordinating several key personnel and activities, and implementing appropriate animal care and use proced...
    Speaker: Javier Guillen, DVM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    3
    JAN 26, 2016 | 8:00 AM
    WEBINAR: Concordance of PTEN gene status in circulating tumor cells and tumor tissue from mCRPC patients
    WEBINAR: Concordance of PTEN gene status in circulating tumor...
    DATE: January 26th, 2016 TIME: 8am pacific, 11am eastern PTEN gene loss occurs frequently in castration-resistant prostate cancer (CRPC) and may drive progression through activation of th...
    Speaker: Edith Szafer-Glusman, PhD
    Sponsored By: Epic Sciences, Epic Sciences
    9
     
     
  • JAN 20, 2016 | 8:00 AM
    Extracellular Vesicle Detection and Analysis via Flow Cytometry
    Extracellular Vesicle Detection and Analysis via Flow Cytometry
    Over the past decade, there has been a rapid growth in studies of secreted membrane vesicles, collectively called extracellular vesicles (EVs). (1) The release of EVs has been reported in the...
    Speaker: Vasilis Toxavidis , John Tigges
    Presented at: Beckman Coulter Life Sciences Virtual Trade Show
    Sponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life Sciences
    7 2
    JAN 12, 2016 | 8:00 AM
    WEBINAR: Combined Use of Multiple Particle Characterization Technologies to Evaluate Targeted Liposomal Formulations: Implications for General Nanoparticle Development
    WEBINAR: Combined Use of Multiple Particle Characterization Technologies...
    January 12, 2016, 8:00am PT, 11:00am ET, 3:00pm GMT Targeted nanoparticle applications have become a major focus of translational development of both diagnostics and therapeutics for clini...
    Speaker: Melvin Klegerman, PhD
    Presented at: Beckman Coulter Life Sciences Virtual Trade Show
    Sponsored By: Beckman Coulter Life Sciences, Beckman Coulter Life Sciences
    11 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 12, 2015 | 9:00 AM
    Introducing an ancestrally diverse whole genome data set for select cohort and control research applications
    Introducing an ancestrally diverse whole genome data set for select...
    Introduction and adoption of whole-genome sequencing has enabled new methods of investigation in the quest for answers in diagnostic odyssey cases as well as in the broader study of genetic d...
    Speaker: Benjamin Solomon, MD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    3
    NOV 12, 2015 | 7:30 AM
    Keynote: Reconceptualizing Genital Herpes Diagnosis and Management
    Keynote: Reconceptualizing Genital Herpes Diagnosis and Management
    As one of the nation's most prevalent sexually transmitted infections, genital herpes represents a diagnostic and therapeutic challenge to clinicians, laboratorians and the patients they...
    Speaker: Edward Hook, III, MD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    2 1
     
     
  • 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
    NOV 03, 2015 | 8:00 AM
    WEBINAR: Health economic value of calprotectin testing: A gastroenterologist's perspective
    WEBINAR: Health economic value of calprotectin testing: A gastroenterologist's...
    FREE to register and attend! •    Patients presenting with persistent abdominal pain and diarrhea are common in clinical practice. Evaluation of these patients, assumin...
    Speaker: KT Park, MD, MS
    Sponsored By: Inova Diagnostics, Inova Diagnostics
    13 2
    OCT 01, 2015 | 9:00 AM
    RNA-editing in melanoma - Case for a sensitive analysis and interpretation platform for the resolution of a diverse molecular process and likely pathogenic variants
    RNA-editing in melanoma - Case for a sensitive analysis and interpretation...
    Of special interest in a clinical setting is the identification and interpretation of somatic variants from the DNA of a tumor/normal matched pair. Studies have shown that a large proportion...
    Speaker: Anika Joecker, PhD
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2015
    2
    SEP 30, 2015 | 9:00 AM
    Inventing Active Surveillance version 2.0
    Inventing Active Surveillance version 2.0
    The burgeoning area of molecular risk assessment (gene expression profiling and/or proteomic tests) in the diagnosis and treatment of prostate cancer is rapidly illuminating how clinicians mi...
    Speaker: Eric Klein, MD
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2015
    2
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