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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 30, 2024 | 7:30 AM
      C.E. CREDITS
      Keynote Presentation: Targeting T-cell Malignancies with CAR-based Immunotherapy: Challenges and Potential Solutions with Live Q&A
      Keynote Presentation: Targeting T-cell Malignancies with CAR-based...
      Chimeric antigen receptor (CAR) T-cell therapy has been extremely successful in treating relapsed/refractory B-cell malignancies, with six CAR T-cell products now FDA approved. Unfortunately...
      Speaker: Sunil S. Raikar, MD
      Presented at: Immuno-Oncology Virtual Event Series 2024
      3
      APR 03, 2024 | 7:30 AM
      Complete Toolbox for Gene Therapy Development with Live Q&A
      Complete Toolbox for Gene Therapy Development with Live Q&A
      Gene therapy has revolutionized the field of medicine, and it has the potential to cure a wide variety of genetic disorders. Gene therapy involves the introduction of a functional gene into...
      Speaker: Roumen Bogoev, MSc
      Presented at: Bioprocessing Virtual Event Series 2024
      Sponsored By: GenScript
      2
      MAR 14, 2024 | 3:00 PM
      C.E. CREDITS
      AI revolution in diagnostic pathology: Is the tide turning?
      AI revolution in diagnostic pathology: Is the tide turning?
      The practice of diagnostic pathology has gone through a disruptive transformation in which multiple tools such as digital imaging, advanced artificial intelligence algorithms, and computer-a...
      Speaker: Anil Parwani, M.D., Ph.D., M.B.A.
      Presented at: Precision Medicine in Solid Tumors
      7 1
      FEB 29, 2024 | 3:00 PM
      C.E. CREDITS
      Small and mighty: The power of FNA and core biopsy for tumor diagnosis and biomarker testing
      Small and mighty: The power of FNA and core biopsy for tumor diagnosis...
      In recent years, small volume biopsies have been increasingly utilized for diagnosis of tumors in both primary and recurrent settings. Concomitantly, the numbers of ancillary studies for cha...
      Speaker: Dr. Amy Ly
      Presented at: Precision Medicine in Solid Tumors
      16 1
      DEC 05, 2023 | 3:00 PM
      Revolutionizing Drug Development: Synthetic Nanodiscs
      Revolutionizing Drug Development: Synthetic Nanodiscs
      Most FDA-approved therapeutic drugs target transmembrane proteins, yet the development of monoclonal antibodies for multi-transmembrane protein targets has been limited. Despite the abundanc...
      Speaker: Dr. Donghui Ma
      Sponsored By: DIMA Biotech
      11
      NOV 29, 2023 | 9:00 AM
      Labcorp® Plasma Focus™
      Labcorp® Plasma Focus™
      Tumor genomic profiling can be complicated, especially for diseases that commonly have multiple different genomic biomarkers of interest, such as non-small cell lung cancer (NSCLC) and color...
      Speaker: Mark Sausen, PhD , Mohamad Khasawneh, MD
      Sponsored By: Labcorp Oncology
      21
      OCT 26, 2023 | 8:00 AM
      Exploring the Pillar Biosciences research use only (RUO) oncoRevealâ„¢ Solid Tumor 22 Gene Panel Kit and Biomek NGeniuS Next Generation Library Prep System
      Exploring the Pillar Biosciences research use only (RUO) oncoRevealâ„¢...
      In the era of advanced biotechnology, automation plays a crucial role in accelerating cancer research. Next-generation sequencing (NGS) technology has revolutionized cancer research, but lab...
      Speaker: Nicholas Lodato, Ph.D. , Enrique Neumann, Ph.D.
      Sponsored By: Beckman Coulter Life Sciences
      12
      OCT 17, 2023 | 6:00 AM
      Application of T2Magnetic Resonance for Improved Patient Care in the ICU
      Application of T2Magnetic Resonance for Improved Patient Care...
      During this presentation, the speaker will provide insights into the clinical utility of the T2Bacteria and T2Resistance Panels in the intensive care unit (ICU), including real-world clinica...
      Speaker: Charikleia Vrettou, MD, PhD, MRCP, EDIC
      Sponsored By: T2 Biosystems, Inc.
      16
      OCT 10, 2023 | 8:00 AM
      Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance
      Highlights of the In Vitro Sections of the Draft ICH Drug Interaction...
      In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group...
      Speaker: Brian Ogilvie, PhD
      Sponsored By: BioIVT
      10
      On Demand
      Informed Consent in Cancer Research: Fostering Patient-Centric Engagement
      Informed Consent in Cancer Research: Fostering Patient-Centric...
      Informed consent (IC) is a fundamental aspect of ethical clinical research, safeguarding the rights and well-being of participants. It empowers participants with comprehensive information ab...
      Speaker: Montserrat Valdes, MSc
      Presented at: Cancer Research & Immuno-Oncology Week Virtual Event Series 2023
      3
      SEP 20, 2023 | 7:30 AM
      Keynote Presentation: The NIH Microphysiological Systems Program: Tissue on Chips for Safety, Efficacy, and Precision Medicine Studies with Live Q&A
      Keynote Presentation: The NIH Microphysiological Systems Program:...
      Current methods used to predict safety and efficacy of candidate drugs accounts for as much as 90% failure rate. Approximately 30% of drugs have failed......
      Speaker: Danilo A. Tagle, PhD
      Presented at: Cell Biology Virtual Event Series 2023
      3
      SEP 14, 2023 | 8:00 AM
      Navigating the Opportunities and Challenges in Analytical Development of Flow Cytometry for T-Cell Therapy: A Primer for Cell Therapy Guidelines and Panel Discussion
      Navigating the Opportunities and Challenges in Analytical Development...
      Flow cytometry plays a crucial role in the rapidly growing field of cell therapy, this method is used to identify different types of cells throughout the manufacturing process, from initial...
      Speaker: Therese Choquette
      Sponsored By: Slingshot Biosciences, Inc.
      19
      AUG 10, 2023 10:45 AM CDT
      Computer System Validation (CSV)
      Computer System Validation (CSV)
      In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations...
      Speaker: Ilyn Santos
      Presented at: 2023 Lab Compliance Connect
      10
      JUN 15, 2023 | 7:00 AM
      Early ctDNA Molecular Response Enhanced Through Integrated Analyses of Cell-Free DNA and Matched White Blood Cells
      Early ctDNA Molecular Response Enhanced Through Integrated Analyses...
      Liquid biopsies represent a transformation in the management of cancer as they have the potential to detect, characterize, and monitor cancers earlier than can be achieved with conventional...
      Speaker: Mark Sausen, PhD , Valsamo Anagnostou, MD, PhD
      Sponsored By: Labcorp Oncology
      11
      MAY 31, 2023 | 10:00 AM
      Current Landscape of Blood Culture Diagnostic Methods
      Current Landscape of Blood Culture Diagnostic Methods
      Date: May 31, 2023 Time: 10:00am (PDT), 1:00pm (EDT), 5:00pm (CEST) Bloodstream infections (BSIs) are defined as a systemic infection resulting from the presence of viable microorganisms in...
      Speaker: Richard Smith, Ph.D.
      Sponsored By: Bruker Microbiology & Infection Diagnostics
      25
      APR 20, 2023 | 7:30 AM
      Keynote Presentation: The Rise of Intoxicating Hemp-Derived Cannabinoids
      Keynote Presentation: The Rise of Intoxicating Hemp-Derived Cannabinoids
      In this session, attorney Bob Hoban will explore the current legal and regulatory landscape in the United States related to intoxicating hemp cannabinoids. Anyone who is keeping a pulse on t...
      Speaker: Robert T. Hoban
      Presented at: Cannabis Sciences Virtual Event Series 2023
      3
      APR 12, 2023 | 8:00 AM
      Role of Brain Biomarkers in the unmet need of assessing Mild Traumatic Brain Injury (mTBI)
      Role of Brain Biomarkers in the unmet need of assessing Mild Traumatic...
      Date: April 12, 2023 Time: 8:00am (PDT), 11:00am (EDT), 5:00pm (CET) Globally 69 million people worldwide suffer from Traumatic Brain Injury (TBI) every year and many of them are mild and ar...
      Speaker: Dr Jaime Marino
      Sponsored By: Abbott
      13
      APR 05, 2023 | 6:00 AM
      The Importance of Digital Lab Platforms and Why Bioprocessing Facilities Need to Adapt Them with Live Q&A
      The Importance of Digital Lab Platforms and Why Bioprocessing...
      Imagine, all of your lab work, your experimental data, your sample information and lineage tracing, your protocols and inventory management tools, all living on one, cohesive platform. What...
      Speaker: Tyler Gurney, MS
      Presented at: Bioprocessing Virtual Event Series 2023
      Sponsored By: eLabNext
      3
      MAR 22, 2023 | 9:00 AM
      Keynote Presentation: Linking Single-Cell Function to Multi-omic Analysis Using 'Lab on a Particle' Technology with Live Q&A
      Keynote Presentation: Linking Single-Cell Function to Multi-omic...
      We have developed 3D-shaped hydrogel microparticle platforms to capture cells, as well as isolate and label their secretions. These “lab on a particle” systems enable sorting cel...
      Speaker: Dino Di Carlo, Ph.D.
      Presented at: Laboratory Automation Virtual Event Series 2023
      6
      JAN 17, 2023 | 9:00 AM
      Preparing for the Worst: The Resurgence of Respiratory Infections
      Preparing for the Worst: The Resurgence of Respiratory Infections
      Date: January 17, 2023 Time: 9:00am (PST), 12:00pm (EST), 6:00pm (CET) As SARS-CoV-2 infections continue to ebb and flow, other respiratory viruses have made a big comeback on the world stag...
      Speaker: Dr. Michelle Tabb
      Sponsored By: Diasorin
      26
      NOV 30, 2022 | 11:00 AM
      How Cystatin C measurement contributes to health care equity
      How Cystatin C measurement contributes to health care equity
      Date: November 30 Time: 11:00am (PDT), 2:00pm (EDT), Kidney function is assessed in the laboratory by measuring serum creatinine (Cr) and/or......
      Speaker: Gabriella Lakos MD, PhD, D (ABMLI)
      Sponsored By: Binding Site
      12
      NOV 16, 2022 | 7:00 PM
      Innovation in Science and Technology: Translating Cellular Therapies from Bench to Bedside
      Innovation in Science and Technology: Translating Cellular Therapies...
      Date: November 16, 2022 Time: 2:00pm (AEST) Date: November 17, 2022 7:00pm (PST), 10:00pm (EST), 4:00am (CET) The growth in FDA-approved cell and gene therapy products for the treatment of d...
      Speaker: Khalid Shah , Jean Qiu
      Sponsored By: Revvity
      26
      NOV 16, 2022 | 8:00 AM
      Verification of Autoantibody Serology Tests: Practical Considerations for the Clinical Laboratory
      Verification of Autoantibody Serology Tests: Practical Considerations...
      Date: November 16, 2022 Time: 8:00am (PST), 11:00am (EST), 5:00pm (CET) Autoantibody assays may have significant differences due to the heterogeneity of autoantibodies, including epitope spe...
      Speaker: Melissa Snyder, PhD, DABCC
      Sponsored By: Bio-Rad Laboratories
      42
      NOV 09, 2022 | 8:00 AM
      Addressing common challenges in lentiviral vector clarification using closed, automated counterflow centrifugation systems
      Addressing common challenges in lentiviral vector clarification...
      Date: November 09, 2022 Time: 8:00am (PST), 11:00am (EST), 5:00pm (CET) The field of cell and gene therapy is rapidly growing. In particular, the use of lentiviruses in CAR-T applications is...
      Speaker: Carl Dargitz , Magda Tomala
      Sponsored By: Thermo Fisher Scientific, Sartorius
      16
    APR 30, 2024 | 7:30 AM
    C.E. CREDITS
    Keynote Presentation: Targeting T-cell Malignancies with CAR-based Immunotherapy: Challenges and Potential Solutions with Live Q&A
    Keynote Presentation: Targeting T-cell Malignancies with CAR-based...
    Chimeric antigen receptor (CAR) T-cell therapy has been extremely successful in treating relapsed/refractory B-cell malignancies, with six CAR T-cell products now FDA approved. Unfortunately...
    Speaker: Sunil S. Raikar, MD
    Presented at: Immuno-Oncology Virtual Event Series 2024
    3
    APR 03, 2024 | 7:30 AM
    Complete Toolbox for Gene Therapy Development with Live Q&A
    Complete Toolbox for Gene Therapy Development with Live Q&A
    Gene therapy has revolutionized the field of medicine, and it has the potential to cure a wide variety of genetic disorders. Gene therapy involves the introduction of a functional gene into...
    Speaker: Roumen Bogoev, MSc
    Presented at: Bioprocessing Virtual Event Series 2024
    Sponsored By: GenScript
    2
    MAR 14, 2024 | 3:00 PM
    C.E. CREDITS
    AI revolution in diagnostic pathology: Is the tide turning?
    AI revolution in diagnostic pathology: Is the tide turning?
    The practice of diagnostic pathology has gone through a disruptive transformation in which multiple tools such as digital imaging, advanced artificial intelligence algorithms, and computer-a...
    Speaker: Anil Parwani, M.D., Ph.D., M.B.A.
    Presented at: Precision Medicine in Solid Tumors
    7 1
    FEB 29, 2024 | 3:00 PM
    C.E. CREDITS
    Small and mighty: The power of FNA and core biopsy for tumor diagnosis and biomarker testing
    Small and mighty: The power of FNA and core biopsy for tumor diagnosis...
    In recent years, small volume biopsies have been increasingly utilized for diagnosis of tumors in both primary and recurrent settings. Concomitantly, the numbers of ancillary studies for cha...
    Speaker: Dr. Amy Ly
    Presented at: Precision Medicine in Solid Tumors
    16 1
    DEC 05, 2023 | 3:00 PM
    Revolutionizing Drug Development: Synthetic Nanodiscs
    Revolutionizing Drug Development: Synthetic Nanodiscs
    Most FDA-approved therapeutic drugs target transmembrane proteins, yet the development of monoclonal antibodies for multi-transmembrane protein targets has been limited. Despite the abundanc...
    Speaker: Dr. Donghui Ma
    Sponsored By: DIMA Biotech
    11
     
     
  • NOV 29, 2023 | 9:00 AM
    Labcorp® Plasma Focus™
    Labcorp® Plasma Focus™
    Tumor genomic profiling can be complicated, especially for diseases that commonly have multiple different genomic biomarkers of interest, such as non-small cell lung cancer (NSCLC) and color...
    Speaker: Mark Sausen, PhD , Mohamad Khasawneh, MD
    Sponsored By: Labcorp Oncology
    21
    OCT 26, 2023 | 8:00 AM
    Exploring the Pillar Biosciences research use only (RUO) oncoRevealâ„¢ Solid Tumor 22 Gene Panel Kit and Biomek NGeniuS Next Generation Library Prep System
    Exploring the Pillar Biosciences research use only (RUO) oncoRevealâ„¢...
    In the era of advanced biotechnology, automation plays a crucial role in accelerating cancer research. Next-generation sequencing (NGS) technology has revolutionized cancer research, but lab...
    Speaker: Nicholas Lodato, Ph.D. , Enrique Neumann, Ph.D.
    Sponsored By: Beckman Coulter Life Sciences
    12
    OCT 17, 2023 | 6:00 AM
    Application of T2Magnetic Resonance for Improved Patient Care in the ICU
    Application of T2Magnetic Resonance for Improved Patient Care...
    During this presentation, the speaker will provide insights into the clinical utility of the T2Bacteria and T2Resistance Panels in the intensive care unit (ICU), including real-world clinica...
    Speaker: Charikleia Vrettou, MD, PhD, MRCP, EDIC
    Sponsored By: T2 Biosystems, Inc.
    16
    OCT 10, 2023 | 8:00 AM
    Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance
    Highlights of the In Vitro Sections of the Draft ICH Drug Interaction...
    In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group...
    Speaker: Brian Ogilvie, PhD
    Sponsored By: BioIVT
    10
    On Demand
    Informed Consent in Cancer Research: Fostering Patient-Centric Engagement
    Informed Consent in Cancer Research: Fostering Patient-Centric...
    Informed consent (IC) is a fundamental aspect of ethical clinical research, safeguarding the rights and well-being of participants. It empowers participants with comprehensive information ab...
    Speaker: Montserrat Valdes, MSc
    Presented at: Cancer Research & Immuno-Oncology Week Virtual Event Series 2023
    3
     
     
  • SEP 20, 2023 | 7:30 AM
    Keynote Presentation: The NIH Microphysiological Systems Program: Tissue on Chips for Safety, Efficacy, and Precision Medicine Studies with Live Q&A
    Keynote Presentation: The NIH Microphysiological Systems Program:...
    Current methods used to predict safety and efficacy of candidate drugs accounts for as much as 90% failure rate. Approximately 30% of drugs have failed......
    Speaker: Danilo A. Tagle, PhD
    Presented at: Cell Biology Virtual Event Series 2023
    3
    SEP 14, 2023 | 8:00 AM
    Navigating the Opportunities and Challenges in Analytical Development of Flow Cytometry for T-Cell Therapy: A Primer for Cell Therapy Guidelines and Panel Discussion
    Navigating the Opportunities and Challenges in Analytical Development...
    Flow cytometry plays a crucial role in the rapidly growing field of cell therapy, this method is used to identify different types of cells throughout the manufacturing process, from initial...
    Speaker: Therese Choquette
    Sponsored By: Slingshot Biosciences, Inc.
    19
    AUG 10, 2023 10:45 AM CDT
    Computer System Validation (CSV)
    Computer System Validation (CSV)
    In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations...
    Speaker: Ilyn Santos
    Presented at: 2023 Lab Compliance Connect
    10
    JUN 15, 2023 | 7:00 AM
    Early ctDNA Molecular Response Enhanced Through Integrated Analyses of Cell-Free DNA and Matched White Blood Cells
    Early ctDNA Molecular Response Enhanced Through Integrated Analyses...
    Liquid biopsies represent a transformation in the management of cancer as they have the potential to detect, characterize, and monitor cancers earlier than can be achieved with conventional...
    Speaker: Mark Sausen, PhD , Valsamo Anagnostou, MD, PhD
    Sponsored By: Labcorp Oncology
    11
    MAY 31, 2023 | 10:00 AM
    Current Landscape of Blood Culture Diagnostic Methods
    Current Landscape of Blood Culture Diagnostic Methods
    Date: May 31, 2023 Time: 10:00am (PDT), 1:00pm (EDT), 5:00pm (CEST) Bloodstream infections (BSIs) are defined as a systemic infection resulting from the presence of viable microorganisms in...
    Speaker: Richard Smith, Ph.D.
    Sponsored By: Bruker Microbiology & Infection Diagnostics
    25
     
     
  • APR 20, 2023 | 7:30 AM
    Keynote Presentation: The Rise of Intoxicating Hemp-Derived Cannabinoids
    Keynote Presentation: The Rise of Intoxicating Hemp-Derived Cannabinoids
    In this session, attorney Bob Hoban will explore the current legal and regulatory landscape in the United States related to intoxicating hemp cannabinoids. Anyone who is keeping a pulse on t...
    Speaker: Robert T. Hoban
    Presented at: Cannabis Sciences Virtual Event Series 2023
    3
    APR 12, 2023 | 8:00 AM
    Role of Brain Biomarkers in the unmet need of assessing Mild Traumatic Brain Injury (mTBI)
    Role of Brain Biomarkers in the unmet need of assessing Mild Traumatic...
    Date: April 12, 2023 Time: 8:00am (PDT), 11:00am (EDT), 5:00pm (CET) Globally 69 million people worldwide suffer from Traumatic Brain Injury (TBI) every year and many of them are mild and ar...
    Speaker: Dr Jaime Marino
    Sponsored By: Abbott
    13
    APR 05, 2023 | 6:00 AM
    The Importance of Digital Lab Platforms and Why Bioprocessing Facilities Need to Adapt Them with Live Q&A
    The Importance of Digital Lab Platforms and Why Bioprocessing...
    Imagine, all of your lab work, your experimental data, your sample information and lineage tracing, your protocols and inventory management tools, all living on one, cohesive platform. What...
    Speaker: Tyler Gurney, MS
    Presented at: Bioprocessing Virtual Event Series 2023
    Sponsored By: eLabNext
    3
    MAR 22, 2023 | 9:00 AM
    Keynote Presentation: Linking Single-Cell Function to Multi-omic Analysis Using 'Lab on a Particle' Technology with Live Q&A
    Keynote Presentation: Linking Single-Cell Function to Multi-omic...
    We have developed 3D-shaped hydrogel microparticle platforms to capture cells, as well as isolate and label their secretions. These “lab on a particle” systems enable sorting cel...
    Speaker: Dino Di Carlo, Ph.D.
    Presented at: Laboratory Automation Virtual Event Series 2023
    6
    JAN 17, 2023 | 9:00 AM
    Preparing for the Worst: The Resurgence of Respiratory Infections
    Preparing for the Worst: The Resurgence of Respiratory Infections
    Date: January 17, 2023 Time: 9:00am (PST), 12:00pm (EST), 6:00pm (CET) As SARS-CoV-2 infections continue to ebb and flow, other respiratory viruses have made a big comeback on the world stag...
    Speaker: Dr. Michelle Tabb
    Sponsored By: Diasorin
    26
     
     
  • NOV 30, 2022 | 11:00 AM
    How Cystatin C measurement contributes to health care equity
    How Cystatin C measurement contributes to health care equity
    Date: November 30 Time: 11:00am (PDT), 2:00pm (EDT), Kidney function is assessed in the laboratory by measuring serum creatinine (Cr) and/or......
    Speaker: Gabriella Lakos MD, PhD, D (ABMLI)
    Sponsored By: Binding Site
    12
    NOV 16, 2022 | 7:00 PM
    Innovation in Science and Technology: Translating Cellular Therapies from Bench to Bedside
    Innovation in Science and Technology: Translating Cellular Therapies...
    Date: November 16, 2022 Time: 2:00pm (AEST) Date: November 17, 2022 7:00pm (PST), 10:00pm (EST), 4:00am (CET) The growth in FDA-approved cell and gene therapy products for the treatment of d...
    Speaker: Khalid Shah , Jean Qiu
    Sponsored By: Revvity
    26
    NOV 16, 2022 | 8:00 AM
    Verification of Autoantibody Serology Tests: Practical Considerations for the Clinical Laboratory
    Verification of Autoantibody Serology Tests: Practical Considerations...
    Date: November 16, 2022 Time: 8:00am (PST), 11:00am (EST), 5:00pm (CET) Autoantibody assays may have significant differences due to the heterogeneity of autoantibodies, including epitope spe...
    Speaker: Melissa Snyder, PhD, DABCC
    Sponsored By: Bio-Rad Laboratories
    42
    NOV 09, 2022 | 8:00 AM
    Addressing common challenges in lentiviral vector clarification using closed, automated counterflow centrifugation systems
    Addressing common challenges in lentiviral vector clarification...
    Date: November 09, 2022 Time: 8:00am (PST), 11:00am (EST), 5:00pm (CET) The field of cell and gene therapy is rapidly growing. In particular, the use of lentiviruses in CAR-T applications is...
    Speaker: Carl Dargitz , Magda Tomala
    Sponsored By: Thermo Fisher Scientific, Sartorius
    16
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