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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

    • JUL 20, 2021 | 8:00 AM
      Bacterial Mitigation Strategies, the FDA Guidance and Implications for Blood Centers and Transfusion Services
      Bacterial Mitigation Strategies, the FDA Guidance and Implications...
      Date: July 20, 2021 Time: 8:00am (PDT), 11:00am (EDT) The FDA released their guidance, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhan...
      Speaker: Baia Lasky
      Sponsored By: BD
      10
      APR 29, 2021 | 1:15 PM
      Oncomine Reporter: A Powerful Tool for Oncology NGS Reports
      Oncomine Reporter: A Powerful Tool for Oncology NGS Reports
      Cancer is among the leading causes of death worldwide. In 2018, there were 18.1 million new cases and 9.5 million cancer-related deaths worldwide. With the advancement of next generation seq...
      Speaker: Xia Li, Ph.D., DABMGG, CG(ASCP), FACMG
      Presented at: OncomineWorld 2022: A Virtual NGS Education Meeting
      4
      APR 22, 2021 | 7:30 AM
      Keynote Presentation: Moving Precision Medicine from 'Exotic' to 'Normal'
      Keynote Presentation: Moving Precision Medicine from 'Exotic'...
      Pharmacogenomics has had rapid implementation over the past decade, with recent growth in application in oncology, mental health, solid organ transplantation, and more. There has been much f...
      Speaker: Dr. Howard L. McLeod, FASCO, FCCP
      Presented at: Genetics Week Virtual Event Series 2021
      2
      APR 21, 2021 | 10:00 AM
      Putting Serological SARS-CoV-2 Testing into Context
      Putting Serological SARS-CoV-2 Testing into Context
      Date: April 21, 2021 Time: 10:00am (PDT), 1:00pm (EDT) Serological testing for SARS-CoV-2 has been steadily adopted into clinical practice over the course of this pandemic. In this webinar,...
      Speaker: Sarah Wheeler, PhD , Veronica Luzzi, PhD, DABCC, FACB , Eduard Grebe, PhD
      Sponsored By: Bio-Rad Laboratories
      21 2
      APR 20, 2021 | 4:30 PM
      C.E. CREDITS
      High-throughput clinical and environmental viral extraction and sequencing
      High-throughput clinical and environmental viral extraction and...
      COVID-19 is a severe disease that has caused >1 million deaths in under one year. As this disease is novel, the molecular and cellular underpinnings of the progressive tissue injury are p...
      Speaker: Christopher Mason, Ph.D
      Presented at: Genetics Week Virtual Event Series 2021
      Sponsored By: Tecan
      2
      APR 14, 2021 | 1:30 PM
      Automated Solutions for SARS-CoV-2 Variant Identification and Surveillance
      Automated Solutions for SARS-CoV-2 Variant Identification and...
      Several SARS-CoV-2 variants are circulating globally. The most prominent variants of concern, including the B.1.1.7, B.1.351 and B1.1.28 lineages, not only carry a constellation of genetic m...
      Speaker: Anthony Tong, PhD , Subodh Nimkar
      Presented at: Coronavirus Series
      Sponsored By: BGI Americas
      3
      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 Veritorâ„¢ System for Rapid Detection of SARS-CoV-2
      Getting to know your BD Veritorâ„¢ 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
      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
      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
      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
      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
      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
      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
    JUL 20, 2021 | 8:00 AM
    Bacterial Mitigation Strategies, the FDA Guidance and Implications for Blood Centers and Transfusion Services
    Bacterial Mitigation Strategies, the FDA Guidance and Implications...
    Date: July 20, 2021 Time: 8:00am (PDT), 11:00am (EDT) The FDA released their guidance, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhan...
    Speaker: Baia Lasky
    Sponsored By: BD
    10
    APR 29, 2021 | 1:15 PM
    Oncomine Reporter: A Powerful Tool for Oncology NGS Reports
    Oncomine Reporter: A Powerful Tool for Oncology NGS Reports
    Cancer is among the leading causes of death worldwide. In 2018, there were 18.1 million new cases and 9.5 million cancer-related deaths worldwide. With the advancement of next generation seq...
    Speaker: Xia Li, Ph.D., DABMGG, CG(ASCP), FACMG
    Presented at: OncomineWorld 2022: A Virtual NGS Education Meeting
    4
    APR 22, 2021 | 7:30 AM
    Keynote Presentation: Moving Precision Medicine from 'Exotic' to 'Normal'
    Keynote Presentation: Moving Precision Medicine from 'Exotic'...
    Pharmacogenomics has had rapid implementation over the past decade, with recent growth in application in oncology, mental health, solid organ transplantation, and more. There has been much f...
    Speaker: Dr. Howard L. McLeod, FASCO, FCCP
    Presented at: Genetics Week Virtual Event Series 2021
    2
    APR 21, 2021 | 10:00 AM
    Putting Serological SARS-CoV-2 Testing into Context
    Putting Serological SARS-CoV-2 Testing into Context
    Date: April 21, 2021 Time: 10:00am (PDT), 1:00pm (EDT) Serological testing for SARS-CoV-2 has been steadily adopted into clinical practice over the course of this pandemic. In this webinar,...
    Speaker: Sarah Wheeler, PhD , Veronica Luzzi, PhD, DABCC, FACB , Eduard Grebe, PhD
    Sponsored By: Bio-Rad Laboratories
    21 2
    APR 20, 2021 | 4:30 PM
    C.E. CREDITS
    High-throughput clinical and environmental viral extraction and sequencing
    High-throughput clinical and environmental viral extraction and...
    COVID-19 is a severe disease that has caused >1 million deaths in under one year. As this disease is novel, the molecular and cellular underpinnings of the progressive tissue injury are p...
    Speaker: Christopher Mason, Ph.D
    Presented at: Genetics Week Virtual Event Series 2021
    Sponsored By: Tecan
    2
     
     
  • APR 14, 2021 | 1:30 PM
    Automated Solutions for SARS-CoV-2 Variant Identification and Surveillance
    Automated Solutions for SARS-CoV-2 Variant Identification and...
    Several SARS-CoV-2 variants are circulating globally. The most prominent variants of concern, including the B.1.1.7, B.1.351 and B1.1.28 lineages, not only carry a constellation of genetic m...
    Speaker: Anthony Tong, PhD , Subodh Nimkar
    Presented at: Coronavirus Series
    Sponsored By: BGI Americas
    3
    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 Veritorâ„¢ System for Rapid Detection of SARS-CoV-2
    Getting to know your BD Veritorâ„¢ 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
    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
    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
    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
    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
    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
     
     
  • 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
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    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
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    OCT 22, 2019 | 9:00 AM
    Preserving Data Integrity: 21 CFR Part 11 Compliance and Osmolality as a Process Parameter
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    DATE: October 22, 2019 TIME: 9:00am PDT, 12:00PM EDT...
    Speaker: Angela Bazigos , Kristeena Wright, PhD , Shweta Nair
    Sponsored By: Advanced Instruments
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