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    FDA

    The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products. They are the government agency responsible for reviewing, approving and regulating medical products, including pharmaceutical drugs and medical devices.

    Webinars

    • APR 14, 2021 | 12:00 AM
      New Technologies for Accessible, Durable and Broadly Protective Coronavirus Vaccines
      New Technologies for Accessible, Durable and Broadly Protective...
      Over a year into the COVID-19 pandemic, key vulnerable populations in the United States and across the world lack access to effective vaccines. IDRI has developed technology that addresses s...
      Speaker: Corey Casper, M.D., MPH
      Presented at: Coronavirus Series
      20
      APR 14, 2021 | 12:00 AM
      Clarigene: a Pandemic Diagnostic Story
      Clarigene: a Pandemic Diagnostic Story
      Developing an in vitro diagnostic device is often a complex and demanding process. Doing so in the midst of a pandemic and the IVD global supply chain stretched like never before, with proje...
      Speaker: Michael Risley, PhD
      Presented at: Coronavirus Series
      3
      APR 07, 2021 | 12:00 AM
      Niosomes as a bilayer nanocarrier for combinative drug delivery
      Niosomes as a bilayer nanocarrier for combinative drug delivery
      The past few decades have seen a substantial increase in the research based on nanocarrier based combinative drug therapies in various diseases such as cancer, tuberculosis, Alzheimer’...
      Speaker: Pratik Kulkarni, PhD
      Presented at: Bioprocessing Virtual Event Series 2021
      2
      MAR 30, 2021 | 11:00 AM
      Getting to know your BD Veritor™ System for Rapid Detection of SARS-CoV-2
      Getting to know your BD Veritor™ System for Rapid Detection of...
      Date: March 30, 2021 Time: 11:00am (PDT), 2:00pm (EDT) As the world continues to have a need for COVID-19 testing, BD offers a reliable rapid antigen COVID-19 testing solution through the BD...
      Speaker: David Barrett, MT (ASCP) , Chris Girard
      Sponsored By: BD
      4
      NOV 12, 2020 | 6:00 AM
      Standardization with Clinical Digital Pathology - The Ki-67 Case
      Standardization with Clinical Digital Pathology - The Ki-67 Case
      The nuclear proliferation biomarker Ki-67 has multiple potential roles in breast and other cancers, both as a prognostic but also predictive marker. However, several studies have shown that...
      Speaker: Dzenita Omanovic
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      Sponsored By: Visiopharm®
      1
      SEP 23, 2020 | 6:30 AM
      Mass Cytometry in Translational Research: Session I
      Mass Cytometry in Translational Research: Session I
      Single-cell mass cytometry identifies mechanisms of resistance to immunotherapy in AML 6:30–7:00 am PDT Presented By: Shelley Herbrich, PhD Understanding CD19 negative relapse followin...
      Speaker: Shelley Herbrich, PhD , Kara L. Davis, DO , Bernd Bodenmiller, PhD
      Presented at: 9th Annual Fluidigm Mass Cytometry Virtual Summit
      2
      SEP 08, 2020 | 9:00 AM
      Keynote Presentation: A Universal Influenza Virus Vaccine
      Keynote Presentation: A Universal Influenza Virus Vaccine
      Seasonal and pandemic influenza virus infections can cause significant disease worldwide. Current vaccines only provide limited, short-lived protection, and antigenic drift/shift in the hema...
      Speaker: Peter Palese, PhD
      Presented at: Microbiology Week Virtual Event Series 2020
      3
      AUG 06, 2020 | 10:00 AM
      Part III: Exploring the inhibition of Alk2 kinase and dimerization of EGFR kinase
      Part III: Exploring the inhibition of Alk2 kinase and dimerization...
      One of the most common pathologically relevant mutated variants of ALK-2 (activin receptor-like kinase-2) has a point mutation (R206H) in its Ser/Thr kinase domain that promotes uncontrolled...
      Speaker: Kumar Ashtekar, PhD
      Presented at: 2020 Beckman Symposium
      1
      JUN 09, 2020 | 10:00 AM
      Impacting Patient Outcomes With Rapid Positive Blood Culture ID Utilizing MALDI Mass Spectrometry
      Impacting Patient Outcomes With Rapid Positive Blood Culture ID...
      DATE: June 9, 2020 TIME: 10:00am PT, 1:00pm ET The presentation will first discuss sepsis as a disease and then explain the importance of performing diagnostic tests in the clinical labora...
      Speaker: William (Ike) Northern
      Sponsored By: Bruker Microbiology & Infection Diagnostics
      29
      APR 29, 2020 | 6:00 AM
      Quality Aspects and Applications for Multiplex Immunossays
      Quality Aspects and Applications for Multiplex Immunossays
      Background: The NMI applies miniaturized multiplex immunoassays for more than two decades. At the NMI commercially available multiplex immunoassays are applied for sample screening as well a...
      Speaker: Nicole Schneiderhan-Marra, PhD
      Presented at: xMAP® Connect Virtual Conference (On-Demand)
      1
      APR 29, 2020 | 6:00 AM
      Direct Detection and Typing of Variety Pathogens Important for Human and Animal Health Using xMAP Technology
      Direct Detection and Typing of Variety Pathogens Important for...
      Background and aim: Rapid and complex diagnosis of viral, bacterial and parasitic infections is highly desirable not only in clinical practice, but also in food safety or early warning syste...
      Speaker: Petr Kralik, PhD
      Presented at: xMAP® Connect Virtual Conference (On-Demand)
      2
      APR 29, 2020 | 6:00 AM
      Antitumor Immune Activity $ Safety of a Novel PD-1 Vaccine Alone & in Combination With 2 Chimeric HER-2 Peptide Vaccine in Syngeneic Balb/C & C57Bl/6 Models & in Canine and Non-Human Primates
      Antitumor Immune Activity $ Safety of a Novel PD-1 Vaccine Alone...
      ...
      Speaker: Pravin Kaumaya, PhD
      Presented at: xMAP® Connect Virtual Conference (On-Demand)
      1
      JAN 01, 2020 | 6:00 AM
      Microfabricated Human Liver Tissues for Drug Development
      Microfabricated Human Liver Tissues for Drug Development
      The liver plays a critical role in the metabolism and clearance of more than 70% of marketed drugs. Furthermore, toxicity to the liver is a major reason for preclinical and clinical drug fai...
      Speaker: Salman Khetani, PhD
      Presented at: Drug Discovery & Development Virtual Event Series 2020
      1
      JAN 01, 2020 | 6:00 AM
      Vancomycin:  How might Urinary Biomarkers and Precision Dosing create Precision Medicine for the most frequently utilized antibiotic in the hospital?
      Vancomycin: How might Urinary Biomarkers and Precision Dosing...
      Learning Objectives: 1. Describe the exposure response relationships with vancomycin and acute kidney injury 2. Define biomarkers that may be useful to improve Precision Dosing...
      Speaker: Marc Scheetz, PharmD, MSc, FCCP, FCP
      Presented at: Drug Discovery & Development Virtual Event Series 2020
      1
      NOV 14, 2019 | 10:30 AM
      Identifying the PIK3CA mutations that make a difference in breast cancer with the QIAGEN therascreen® PIK3CA RGQ PCR Kit
      Identifying the PIK3CA mutations that make a difference in breast...
      Breast cancer is the most frequently occurring form of cancer in women. While 5-year survival rates for localized disease approach 99%, cases of advanced breast cancer have a much poorer pro...
      Speaker: Benjamin Chaffey, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2019
      Sponsored By: QIAGEN
      1
      NOV 06, 2019 | 1:30 PM
      Impact of the cobas Liat® Flu Assay on Clinical Decision Making in the Emergency Department Setting (Clade Study Group)
      Impact of the cobas Liat® Flu Assay on Clinical Decision Making...
      Respiratory viral infections remain a leading cause of medical visits and can contribute significantly to morbidity and mortality. Influenza, together with pneumonia, is the leading infectiou...
      Speaker: Glen Hansen, PhD
      Presented at: Influenza Virtual Event Series 2019
      3 1
      NOV 06, 2019 | 1:30 PM
      Challenges towards a Universal Influenza Virus Vaccine
      Challenges towards a Universal Influenza Virus Vaccine
      Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and vaccine...
      Speaker: Peter Palese, PhD
      Presented at: Influenza Virtual Event Series 2019
      4 1
      OCT 22, 2019 | 9:00 AM
      Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter
      Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality...
      DATE: October 22, 2019 TIME: 9:00am PDT, 12:00PM EDT...
      Speaker: Angela Bazigos , Kristeena Wright, PhD , Shweta Nair
      Sponsored By: Advanced Instruments
      10 1
      OCT 17, 2019 | 10:00 AM
      Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests
      Analytical and Clinical Validation Requirements for Next Generation...
      DATE: October 17, 2019TIME: 10:00am PDTNext generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnost...
      Speaker: Ryan S. Robetorye, M.D., Ph.D.
      Sponsored By: Thermo Fisher Scientific
      10 3
      SEP 19, 2019 | 8:00 AM
      Importance and Role of Biomarkers in the Management of Pediatric Inflammatory Disease
      Importance and Role of Biomarkers in the Management of Pediatric...
      Learning Objectives: Review basic immuno-pathobiology of IBD and the phenotypes of IBD or IBDs - Crohn’s, Ulcerative Colitis and Indeterminate Colitis Briefly describe the epide...
      Speaker: Benjamin Gold, MD, FACG, FAAP
      Sponsored By: Diasorin
      4
      AUG 14, 2019 | 8:00 AM
      The Metagenomics of Dozens of Earth's Cities and One Space Station
      The Metagenomics of Dozens of Earth's Cities and One Space Station
      DATE: August 14, 2019TIME: 8:00am PDT Infectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatically im...
      Speaker: Dr. Christopher Mason
      Sponsored By: Zymo Research
      2
      MAY 15, 2019 | 7:00 AM
      How a complete set of software and validation tools for microplate readers can help GMP/GLP labs meet FDA data integrity guidelines
      How a complete set of software and validation tools for microplate...
      DATE: May 15, 2019TIME: 7:00AM PDT, 10:00AM EDT, 3:00PM BST, 4:00PM CETLaboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific i...
      Speaker: Thomas Hengstl, PhD , Sally Higham
      Sponsored By: Molecular Devices
      6
      APR 11, 2019 | 10:00 AM
      Downstream Processing Challenges in Cell Therapy Manufacturing
      Downstream Processing Challenges in Cell Therapy Manufacturing
      DATE: April 11, 2019TIME: 10:00 AM PSTWith the recent FDA approval of the CAR-T cell therapies Kymriah® from Novartis and Yescarta® from Kite Pharma there has been a renewed i...
      Speaker: Jim Beltzer, MS, PhD , Geoffrey Uhl, MBA, BS
      Sponsored By: TERUMO BCT
      9 1
      APR 10, 2019 | 9:00 AM
      Validation and Implementation of Quantitative Molecular Assays
      Validation and Implementation of Quantitative Molecular Assays
      Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presen...
      Speaker: Morgan Pence, PhD, D(ABMM)
      Presented at: Molecular Diagnostics Virtual Event Series 2019
      Sponsored By: Diasorin
      8
    APR 14, 2021 | 12:00 AM
    New Technologies for Accessible, Durable and Broadly Protective Coronavirus Vaccines
    New Technologies for Accessible, Durable and Broadly Protective...
    Over a year into the COVID-19 pandemic, key vulnerable populations in the United States and across the world lack access to effective vaccines. IDRI has developed technology that addresses s...
    Speaker: Corey Casper, M.D., MPH
    Presented at: Coronavirus Series
    20
    APR 14, 2021 | 12:00 AM
    Clarigene: a Pandemic Diagnostic Story
    Clarigene: a Pandemic Diagnostic Story
    Developing an in vitro diagnostic device is often a complex and demanding process. Doing so in the midst of a pandemic and the IVD global supply chain stretched like never before, with proje...
    Speaker: Michael Risley, PhD
    Presented at: Coronavirus Series
    3
    APR 07, 2021 | 12:00 AM
    Niosomes as a bilayer nanocarrier for combinative drug delivery
    Niosomes as a bilayer nanocarrier for combinative drug delivery
    The past few decades have seen a substantial increase in the research based on nanocarrier based combinative drug therapies in various diseases such as cancer, tuberculosis, Alzheimer’...
    Speaker: Pratik Kulkarni, PhD
    Presented at: Bioprocessing Virtual Event Series 2021
    2
    MAR 30, 2021 | 11:00 AM
    Getting to know your BD Veritor™ System for Rapid Detection of SARS-CoV-2
    Getting to know your BD Veritor™ System for Rapid Detection of...
    Date: March 30, 2021 Time: 11:00am (PDT), 2:00pm (EDT) As the world continues to have a need for COVID-19 testing, BD offers a reliable rapid antigen COVID-19 testing solution through the BD...
    Speaker: David Barrett, MT (ASCP) , Chris Girard
    Sponsored By: BD
    4
    NOV 12, 2020 | 6:00 AM
    Standardization with Clinical Digital Pathology - The Ki-67 Case
    Standardization with Clinical Digital Pathology - The Ki-67 Case
    The nuclear proliferation biomarker Ki-67 has multiple potential roles in breast and other cancers, both as a prognostic but also predictive marker. However, several studies have shown that...
    Speaker: Dzenita Omanovic
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    Sponsored By: Visiopharm®
    1
     
     
  • SEP 23, 2020 | 6:30 AM
    Mass Cytometry in Translational Research: Session I
    Mass Cytometry in Translational Research: Session I
    Single-cell mass cytometry identifies mechanisms of resistance to immunotherapy in AML 6:30–7:00 am PDT Presented By: Shelley Herbrich, PhD Understanding CD19 negative relapse followin...
    Speaker: Shelley Herbrich, PhD , Kara L. Davis, DO , Bernd Bodenmiller, PhD
    Presented at: 9th Annual Fluidigm Mass Cytometry Virtual Summit
    2
    SEP 08, 2020 | 9:00 AM
    Keynote Presentation: A Universal Influenza Virus Vaccine
    Keynote Presentation: A Universal Influenza Virus Vaccine
    Seasonal and pandemic influenza virus infections can cause significant disease worldwide. Current vaccines only provide limited, short-lived protection, and antigenic drift/shift in the hema...
    Speaker: Peter Palese, PhD
    Presented at: Microbiology Week Virtual Event Series 2020
    3
    AUG 06, 2020 | 10:00 AM
    Part III: Exploring the inhibition of Alk2 kinase and dimerization of EGFR kinase
    Part III: Exploring the inhibition of Alk2 kinase and dimerization...
    One of the most common pathologically relevant mutated variants of ALK-2 (activin receptor-like kinase-2) has a point mutation (R206H) in its Ser/Thr kinase domain that promotes uncontrolled...
    Speaker: Kumar Ashtekar, PhD
    Presented at: 2020 Beckman Symposium
    1
    JUN 09, 2020 | 10:00 AM
    Impacting Patient Outcomes With Rapid Positive Blood Culture ID Utilizing MALDI Mass Spectrometry
    Impacting Patient Outcomes With Rapid Positive Blood Culture ID...
    DATE: June 9, 2020 TIME: 10:00am PT, 1:00pm ET The presentation will first discuss sepsis as a disease and then explain the importance of performing diagnostic tests in the clinical labora...
    Speaker: William (Ike) Northern
    Sponsored By: Bruker Microbiology & Infection Diagnostics
    29
    APR 29, 2020 | 6:00 AM
    Quality Aspects and Applications for Multiplex Immunossays
    Quality Aspects and Applications for Multiplex Immunossays
    Background: The NMI applies miniaturized multiplex immunoassays for more than two decades. At the NMI commercially available multiplex immunoassays are applied for sample screening as well a...
    Speaker: Nicole Schneiderhan-Marra, PhD
    Presented at: xMAP® Connect Virtual Conference (On-Demand)
    1
     
     
  • APR 29, 2020 | 6:00 AM
    Direct Detection and Typing of Variety Pathogens Important for Human and Animal Health Using xMAP Technology
    Direct Detection and Typing of Variety Pathogens Important for...
    Background and aim: Rapid and complex diagnosis of viral, bacterial and parasitic infections is highly desirable not only in clinical practice, but also in food safety or early warning syste...
    Speaker: Petr Kralik, PhD
    Presented at: xMAP® Connect Virtual Conference (On-Demand)
    2
    APR 29, 2020 | 6:00 AM
    Antitumor Immune Activity $ Safety of a Novel PD-1 Vaccine Alone & in Combination With 2 Chimeric HER-2 Peptide Vaccine in Syngeneic Balb/C & C57Bl/6 Models & in Canine and Non-Human Primates
    Antitumor Immune Activity $ Safety of a Novel PD-1 Vaccine Alone...
    ...
    Speaker: Pravin Kaumaya, PhD
    Presented at: xMAP® Connect Virtual Conference (On-Demand)
    1
    JAN 01, 2020 | 6:00 AM
    Microfabricated Human Liver Tissues for Drug Development
    Microfabricated Human Liver Tissues for Drug Development
    The liver plays a critical role in the metabolism and clearance of more than 70% of marketed drugs. Furthermore, toxicity to the liver is a major reason for preclinical and clinical drug fai...
    Speaker: Salman Khetani, PhD
    Presented at: Drug Discovery & Development Virtual Event Series 2020
    1
    JAN 01, 2020 | 6:00 AM
    Vancomycin:  How might Urinary Biomarkers and Precision Dosing create Precision Medicine for the most frequently utilized antibiotic in the hospital?
    Vancomycin: How might Urinary Biomarkers and Precision Dosing...
    Learning Objectives: 1. Describe the exposure response relationships with vancomycin and acute kidney injury 2. Define biomarkers that may be useful to improve Precision Dosing...
    Speaker: Marc Scheetz, PharmD, MSc, FCCP, FCP
    Presented at: Drug Discovery & Development Virtual Event Series 2020
    1
    NOV 14, 2019 | 10:30 AM
    Identifying the PIK3CA mutations that make a difference in breast cancer with the QIAGEN therascreen® PIK3CA RGQ PCR Kit
    Identifying the PIK3CA mutations that make a difference in breast...
    Breast cancer is the most frequently occurring form of cancer in women. While 5-year survival rates for localized disease approach 99%, cases of advanced breast cancer have a much poorer pro...
    Speaker: Benjamin Chaffey, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2019
    Sponsored By: QIAGEN
    1
     
     
  • NOV 06, 2019 | 1:30 PM
    Impact of the cobas Liat® Flu Assay on Clinical Decision Making in the Emergency Department Setting (Clade Study Group)
    Impact of the cobas Liat® Flu Assay on Clinical Decision Making...
    Respiratory viral infections remain a leading cause of medical visits and can contribute significantly to morbidity and mortality. Influenza, together with pneumonia, is the leading infectiou...
    Speaker: Glen Hansen, PhD
    Presented at: Influenza Virtual Event Series 2019
    3 1
    NOV 06, 2019 | 1:30 PM
    Challenges towards a Universal Influenza Virus Vaccine
    Challenges towards a Universal Influenza Virus Vaccine
    Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and vaccine...
    Speaker: Peter Palese, PhD
    Presented at: Influenza Virtual Event Series 2019
    4 1
    OCT 22, 2019 | 9:00 AM
    Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter
    Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality...
    DATE: October 22, 2019 TIME: 9:00am PDT, 12:00PM EDT...
    Speaker: Angela Bazigos , Kristeena Wright, PhD , Shweta Nair
    Sponsored By: Advanced Instruments
    10 1
    OCT 17, 2019 | 10:00 AM
    Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests
    Analytical and Clinical Validation Requirements for Next Generation...
    DATE: October 17, 2019TIME: 10:00am PDTNext generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnost...
    Speaker: Ryan S. Robetorye, M.D., Ph.D.
    Sponsored By: Thermo Fisher Scientific
    10 3
    SEP 19, 2019 | 8:00 AM
    Importance and Role of Biomarkers in the Management of Pediatric Inflammatory Disease
    Importance and Role of Biomarkers in the Management of Pediatric...
    Learning Objectives: Review basic immuno-pathobiology of IBD and the phenotypes of IBD or IBDs - Crohn’s, Ulcerative Colitis and Indeterminate Colitis Briefly describe the epide...
    Speaker: Benjamin Gold, MD, FACG, FAAP
    Sponsored By: Diasorin
    4
     
     
  • AUG 14, 2019 | 8:00 AM
    The Metagenomics of Dozens of Earth's Cities and One Space Station
    The Metagenomics of Dozens of Earth's Cities and One Space Station
    DATE: August 14, 2019TIME: 8:00am PDT Infectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatically im...
    Speaker: Dr. Christopher Mason
    Sponsored By: Zymo Research
    2
    MAY 15, 2019 | 7:00 AM
    How a complete set of software and validation tools for microplate readers can help GMP/GLP labs meet FDA data integrity guidelines
    How a complete set of software and validation tools for microplate...
    DATE: May 15, 2019TIME: 7:00AM PDT, 10:00AM EDT, 3:00PM BST, 4:00PM CETLaboratories operating under GMP or GLP regulations must follow guidelines set by agencies to protect scientific i...
    Speaker: Thomas Hengstl, PhD , Sally Higham
    Sponsored By: Molecular Devices
    6
    APR 11, 2019 | 10:00 AM
    Downstream Processing Challenges in Cell Therapy Manufacturing
    Downstream Processing Challenges in Cell Therapy Manufacturing
    DATE: April 11, 2019TIME: 10:00 AM PSTWith the recent FDA approval of the CAR-T cell therapies Kymriah® from Novartis and Yescarta® from Kite Pharma there has been a renewed i...
    Speaker: Jim Beltzer, MS, PhD , Geoffrey Uhl, MBA, BS
    Sponsored By: TERUMO BCT
    9 1
    APR 10, 2019 | 9:00 AM
    Validation and Implementation of Quantitative Molecular Assays
    Validation and Implementation of Quantitative Molecular Assays
    Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presen...
    Speaker: Morgan Pence, PhD, D(ABMM)
    Presented at: Molecular Diagnostics Virtual Event Series 2019
    Sponsored By: Diasorin
    8
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