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    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 02, 2019 | 10:00 AM
      Instrument Compliance for a Quality System: A Candid Conversation About IQ/OQ/PQ
      Instrument Compliance for a Quality System: A Candid Conversation...
      DATE: April 2nd, 2019TIME: 10:00AM PDTFor laboratories that operate within a quality management system, compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, I...
      Speaker: Randall Albright , Dean Rainbolt
      Sponsored By: Thermo Fisher Scientific
      9
      APR 02, 2019 | 3:00 PM
      L'interférence de la Biotine sur les immunoanalyses
      L'interférence de la Biotine sur les immunoanalyses
      DATE: April 2, 2019TIME: 3:00pm CEST Dans ce webinaire, Marie Piketty rappelle que depuis quelques années, plusieurs cas d'interférences provoquées par l...
      Speaker: Marie Piketty, Biology MSC
      Sponsored By: Abbott
      6 1
      MAR 28, 2019 | 6:00 AM
      Challenges of Cannabis Testing in the US and Abroad
      Challenges of Cannabis Testing in the US and Abroad
      The vast majority of  US states and other countries require quality control testing of cannabis and cannabis processed products prior to release for distribution. The purpose of product...
      Speaker: Deborah Miran
      Presented at: Cannabis Sciences Virtual Event Series 2019
      1
      MAR 27, 2019 | 1:30 PM
      The Efficacy of High CBD Low THC for Better Outcomes in Medical Marijuana Treatment Programs
      The Efficacy of High CBD Low THC for Better Outcomes in Medical...
      Many people are using CBD effectively as part of their daily treatment for various ailments across the globe, what is all the hype about CBD/THC and why is it being touted as a wonder medici...
      Speaker: Ruth Bertrand, LPN
      Presented at: Cannabis Sciences Virtual Event Series 2019
      4
      MAR 27, 2019 | 9:00 AM
      Keynote Presentation: Considering Cannabis as a Traditional Crop
      Keynote Presentation: Considering Cannabis as a Traditional Crop
      Cannabis sativa is an herbaceous plant of high interest, with applications of the plant and its products varied and ripe with investment. The Cannabis industry experienced a new surge of busi...
      Speaker: Gia Fazio, PhD
      Presented at: Cannabis Sciences Virtual Event Series 2019
      1
      MAR 14, 2019 | 11:00 AM
      Understanding Batten Disease Pathogenesis
      Understanding Batten Disease Pathogenesis
      Batten disease or the Neuronal Ceroid Lipofuscinoses (NCLss) are each the result of inherited mutations that result in lysosomal dysfunction. Some of these disorders are due to deficiencies i...
      Speaker: Jonathan Cooper, PhD
      Presented at: Neuroscience Virtual Event Series 2019
      1
      FEB 27, 2019 | 1:30 PM
      Comprehensive NTRK Fusion Detection, Agnostic of the Fusion Partner, for Optimal Identification of Rare Genomic Events Using TruSightTM Oncology 500
      Comprehensive NTRK Fusion Detection, Agnostic of the Fusion Partner,...
      NTRK fusions are rare but important recent biomarkers linked to response to new TRK inhibitors. Comprehensive genomic profiling on all solid tumors permits detection of rare genomic events an...
      Speaker: Phillip Febbo, MD , Maude Champagne
      Presented at: Drug Discovery Virtual Event Series 2019
      Sponsored By: Illumina
      4
      FEB 27, 2019 | 12:00 PM
      Studies on Malignancies With a Novel Proliferation Biomarker
      Studies on Malignancies With a Novel Proliferation Biomarker
      Studies in drug development and on hematological and solid Tumors with a Thymidine Kinase 1 immunoassayThere are many tumor biomarkers but, they mostly reflect tumor mass or past growth,...
      Speaker: Martin Shaw
      Presented at: Drug Discovery Virtual Event Series 2019
      1
      FEB 05, 2019 | 9:00 AM
      Complimentary Webinar: Data Privacy and Other Clinical Data Management Challenges
      Complimentary Webinar: Data Privacy and Other Clinical Data Management...
      DATE:  February 5, 2019TIME:  9:00am PST, 12:00pm EST CloudLIMS.com is pleased to invite you to attend a complimentary webinar. The webinar focuses on the importa...
      Speaker: Marianne Henderson
      Sponsored By: CloudLIMS
      9
      NOV 14, 2018 | 6:00 AM
      Improving Sepsis Management with Same-Day Results from the Lab
      Improving Sepsis Management with Same-Day Results from the Lab
      Sepsis is the Achilles’ heel of health care. Despite being relatively unknown to the public, it is a top killer in hospitals and the cost burden is crushing to our healthcare system. Mo...
      Speaker: John McDonough
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2018
      2 1
      OCT 10, 2018 | 9:00 AM
      Using Radiotherapy, Tumor-Reactive mAb and IL2 to Engage Innate and Adaptive Antitumor Immunity
      Using Radiotherapy, Tumor-Reactive mAb and IL2 to Engage Innate...
      In prior work, we have pursued how tumor reactive monoclonal antibody (mAb), together with activators of innate immune cells, like NK cells, can augment antibody dependent cell-mediated cytot...
      Speaker: Paul Sondel, MD, PhD
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2018
      1
      OCT 10, 2018 | 6:00 AM
      The Role of Vaccination for the Treatment and Prevention of Breast and Ovarian Cancers
      The Role of Vaccination for the Treatment and Prevention of Breast...
      With over 265,000 new cases per year and over 50,000 deaths, breast and ovarian cancers represent a significant health burden in the USA.  Prior work has demonstrated that CD4 helper T c...
      Speaker: Keith Knutson, PhD
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2018
      6
      OCT 03, 2018 | 10:30 AM
      Integrating Novel Advances in Gene Delivery and Genome Engineering for Therapeutic Application
      Integrating Novel Advances in Gene Delivery and Genome Engineering...
      There have been an increasing number of successful human gene therapy clinical trials, and in particular gene delivery vehicles or vectors based on the adeno-associated virus (AAV) have enabl...
      Speaker: David Schaffer, PhD
      Presented at: CRISPR Virtual Event Series 2018
      2
      SEP 13, 2018 | 7:30 AM
      Keynote Presentation: Tracking the Resistome in One Health Surveillance
      Keynote Presentation: Tracking the Resistome in One Health Surveillance
      In the US, the National Antimicrobial Resistance Monitoring System has been using WGS of Salmonella as a tool of routine surveillance since 2013. To date, NARMS has generated MIC and WGS data...
      Speaker: Patrick McDermott, MS, PhD
      Presented at: Microbiology & Immunology Virtual Event Series 2018
      2
      AUG 07, 2018 | 8:00 AM
      Using Reference Standards to Validate your NGS Oncology Workflow
      Using Reference Standards to Validate your NGS Oncology Workflow
      DATE: August 7, 2018TIME: 08:00AM PDT, 11:00AM EDTWe are currently at an exciting precipice in clinical oncology management, where an increased rate of biomarker identification is drivi...
      Speaker: Hannah Child, PhD
      Sponsored By: Horizon Discovery
      10 1
      JUN 20, 2018 | 1:30 PM
      Regulation of Precision Medicine
      Regulation of Precision Medicine
      Regulation of precision medicine is rapidly evolving.  The pre-existing regulatory framework did not contemplate many of the products and technologies which are becoming available with p...
      Speaker: Neil Belson
      Presented at: Precision Medicine Virtual Event Series 2018
      3
      JUN 20, 2018 | 7:00 AM
      Utilizing Same-Day Sepsis Pathogen ID for Faster Therapy, Enhanced Stewardship, Improved Outcomes
      Utilizing Same-Day Sepsis Pathogen ID for Faster Therapy, Enhanced...
      DATE: June 20, 2018TIME: 07:00AM PDT, 10:00AM EDTIntroducing GE’s New Lyo-StableTM service. Sepsis is one of the top challenges facing hospitals in terms of clinical outcomes...
      Speaker: Cornelius Clancy, MD
      Sponsored By: T2 Biosystems, Inc.
      9 4
      MAY 30, 2018 | 7:30 AM
      Keynote Presentation: Robotic Automation of Human Cell Culture for Regenerative and Reparative Medicine
      Keynote Presentation: Robotic Automation of Human Cell Culture...
      Growing living human cells in vitro for basic research, drug discovery and reparative/regenerative medicine is challenged by the difficulty in developing methods for reproducibly and cost eff...
      Speaker: Robin Felder, PhD
      Presented at: Lab Automation Virtual Event Series 2018
      3
      MAY 10, 2018 | 12:00 PM
      C.E. CREDITS
      Precision Medicine and Pharmacogenomics in Community Pharmacy and Primary Care Setting
      Precision Medicine and Pharmacogenomics in Community Pharmacy...
      To provide insight on the utility and practicality of implementing a pharmacist-driven pharmacogenomics program in a community pharmacy or primary care setting and to provide a clinical updat...
      Speaker: Amina Abubakar, PharmD, AAHIVP
      Presented at: Genetics and Genomics Virtual Event Series 2018
      2
      APR 11, 2018 | 10:30 AM
      Medicare's New National Coverage Determination for Next Generation Sequencing: What Does it Mean for Diagnostic Laboratories?
      Medicare's New National Coverage Determination for Next Generation...
      On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) for the use of Next Generation Sequencing (NGS) for tumor profiling i...
      Speaker: Roger Klein MD, JD, FCAP
      Presented at: Molecular Diagnostics Virtual Event Series 2018
      1
      APR 11, 2018 | 7:30 AM
      Keynote Presentation: A Regulatory Perspective on Molecular Diagnostic Devices
      Keynote Presentation: A Regulatory Perspective on Molecular Diagnostic...
      Advancements and innovation in in vitro diagnostic device (IVD) development are important for the success of personalized medicine. This is highlighted by the dramatic increase in the number...
      Speaker: Eunice Lee, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2018
      15 2
      APR 04, 2018 | 8:00 AM
      Reducing Human Errors in Pharmaceutical Manufacturing QC
      Reducing Human Errors in Pharmaceutical Manufacturing QC
      A recent report by CPhI highlights the pharmaceutical industry drive to improve productivity by improving right first time quality and reducing overhead costs1. Another report indicates that...
      Speaker: Tony Harrison
      Sponsored By: Beckman Coulter Life Sciences
      7 3
      MAR 29, 2018 | 1:30 PM
      Global Cannabis Regulation and Testing Standards
      Global Cannabis Regulation and Testing Standards
      For a plant that has been legal in some states for over 20 years, there has been an attitude that “cannabis never killed anyone.” While we don’t have the necessary rese...
      Speaker: Donald Land, PhD
      Presented at: Cannabis Sciences Virtual Event Series 2018
      4
      MAR 28, 2018 | 9:00 AM
      Drug Development and Approval in the U.S.: Regulatory Challenges and Opportunities for Cannabis Therapies
      Drug Development and Approval in the U.S.: Regulatory Challenges...
      Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for thera...
      Speaker: Emily Leongini
      Presented at: Cannabis Sciences Virtual Event Series 2018
      1
    APR 02, 2019 | 10:00 AM
    Instrument Compliance for a Quality System: A Candid Conversation About IQ/OQ/PQ
    Instrument Compliance for a Quality System: A Candid Conversation...
    DATE: April 2nd, 2019TIME: 10:00AM PDTFor laboratories that operate within a quality management system, compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, I...
    Speaker: Randall Albright , Dean Rainbolt
    Sponsored By: Thermo Fisher Scientific
    9
    APR 02, 2019 | 3:00 PM
    L'interférence de la Biotine sur les immunoanalyses
    L'interférence de la Biotine sur les immunoanalyses
    DATE: April 2, 2019TIME: 3:00pm CEST Dans ce webinaire, Marie Piketty rappelle que depuis quelques années, plusieurs cas d'interférences provoquées par l...
    Speaker: Marie Piketty, Biology MSC
    Sponsored By: Abbott
    6 1
    MAR 28, 2019 | 6:00 AM
    Challenges of Cannabis Testing in the US and Abroad
    Challenges of Cannabis Testing in the US and Abroad
    The vast majority of  US states and other countries require quality control testing of cannabis and cannabis processed products prior to release for distribution. The purpose of product...
    Speaker: Deborah Miran
    Presented at: Cannabis Sciences Virtual Event Series 2019
    1
    MAR 27, 2019 | 1:30 PM
    The Efficacy of High CBD Low THC for Better Outcomes in Medical Marijuana Treatment Programs
    The Efficacy of High CBD Low THC for Better Outcomes in Medical...
    Many people are using CBD effectively as part of their daily treatment for various ailments across the globe, what is all the hype about CBD/THC and why is it being touted as a wonder medici...
    Speaker: Ruth Bertrand, LPN
    Presented at: Cannabis Sciences Virtual Event Series 2019
    4
    MAR 27, 2019 | 9:00 AM
    Keynote Presentation: Considering Cannabis as a Traditional Crop
    Keynote Presentation: Considering Cannabis as a Traditional Crop
    Cannabis sativa is an herbaceous plant of high interest, with applications of the plant and its products varied and ripe with investment. The Cannabis industry experienced a new surge of busi...
    Speaker: Gia Fazio, PhD
    Presented at: Cannabis Sciences Virtual Event Series 2019
    1
     
     
  • MAR 14, 2019 | 11:00 AM
    Understanding Batten Disease Pathogenesis
    Understanding Batten Disease Pathogenesis
    Batten disease or the Neuronal Ceroid Lipofuscinoses (NCLss) are each the result of inherited mutations that result in lysosomal dysfunction. Some of these disorders are due to deficiencies i...
    Speaker: Jonathan Cooper, PhD
    Presented at: Neuroscience Virtual Event Series 2019
    1
    FEB 27, 2019 | 1:30 PM
    Comprehensive NTRK Fusion Detection, Agnostic of the Fusion Partner, for Optimal Identification of Rare Genomic Events Using TruSightTM Oncology 500
    Comprehensive NTRK Fusion Detection, Agnostic of the Fusion Partner,...
    NTRK fusions are rare but important recent biomarkers linked to response to new TRK inhibitors. Comprehensive genomic profiling on all solid tumors permits detection of rare genomic events an...
    Speaker: Phillip Febbo, MD , Maude Champagne
    Presented at: Drug Discovery Virtual Event Series 2019
    Sponsored By: Illumina
    4
    FEB 27, 2019 | 12:00 PM
    Studies on Malignancies With a Novel Proliferation Biomarker
    Studies on Malignancies With a Novel Proliferation Biomarker
    Studies in drug development and on hematological and solid Tumors with a Thymidine Kinase 1 immunoassayThere are many tumor biomarkers but, they mostly reflect tumor mass or past growth,...
    Speaker: Martin Shaw
    Presented at: Drug Discovery Virtual Event Series 2019
    1
    FEB 05, 2019 | 9:00 AM
    Complimentary Webinar: Data Privacy and Other Clinical Data Management Challenges
    Complimentary Webinar: Data Privacy and Other Clinical Data Management...
    DATE:  February 5, 2019TIME:  9:00am PST, 12:00pm EST CloudLIMS.com is pleased to invite you to attend a complimentary webinar. The webinar focuses on the importa...
    Speaker: Marianne Henderson
    Sponsored By: CloudLIMS
    9
    NOV 14, 2018 | 6:00 AM
    Improving Sepsis Management with Same-Day Results from the Lab
    Improving Sepsis Management with Same-Day Results from the Lab
    Sepsis is the Achilles’ heel of health care. Despite being relatively unknown to the public, it is a top killer in hospitals and the cost burden is crushing to our healthcare system. Mo...
    Speaker: John McDonough
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2018
    2 1
     
     
  • OCT 10, 2018 | 9:00 AM
    Using Radiotherapy, Tumor-Reactive mAb and IL2 to Engage Innate and Adaptive Antitumor Immunity
    Using Radiotherapy, Tumor-Reactive mAb and IL2 to Engage Innate...
    In prior work, we have pursued how tumor reactive monoclonal antibody (mAb), together with activators of innate immune cells, like NK cells, can augment antibody dependent cell-mediated cytot...
    Speaker: Paul Sondel, MD, PhD
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2018
    1
    OCT 10, 2018 | 6:00 AM
    The Role of Vaccination for the Treatment and Prevention of Breast and Ovarian Cancers
    The Role of Vaccination for the Treatment and Prevention of Breast...
    With over 265,000 new cases per year and over 50,000 deaths, breast and ovarian cancers represent a significant health burden in the USA.  Prior work has demonstrated that CD4 helper T c...
    Speaker: Keith Knutson, PhD
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2018
    6
    OCT 03, 2018 | 10:30 AM
    Integrating Novel Advances in Gene Delivery and Genome Engineering for Therapeutic Application
    Integrating Novel Advances in Gene Delivery and Genome Engineering...
    There have been an increasing number of successful human gene therapy clinical trials, and in particular gene delivery vehicles or vectors based on the adeno-associated virus (AAV) have enabl...
    Speaker: David Schaffer, PhD
    Presented at: CRISPR Virtual Event Series 2018
    2
    SEP 13, 2018 | 7:30 AM
    Keynote Presentation: Tracking the Resistome in One Health Surveillance
    Keynote Presentation: Tracking the Resistome in One Health Surveillance
    In the US, the National Antimicrobial Resistance Monitoring System has been using WGS of Salmonella as a tool of routine surveillance since 2013. To date, NARMS has generated MIC and WGS data...
    Speaker: Patrick McDermott, MS, PhD
    Presented at: Microbiology & Immunology Virtual Event Series 2018
    2
    AUG 07, 2018 | 8:00 AM
    Using Reference Standards to Validate your NGS Oncology Workflow
    Using Reference Standards to Validate your NGS Oncology Workflow
    DATE: August 7, 2018TIME: 08:00AM PDT, 11:00AM EDTWe are currently at an exciting precipice in clinical oncology management, where an increased rate of biomarker identification is drivi...
    Speaker: Hannah Child, PhD
    Sponsored By: Horizon Discovery
    10 1
     
     
  • JUN 20, 2018 | 1:30 PM
    Regulation of Precision Medicine
    Regulation of Precision Medicine
    Regulation of precision medicine is rapidly evolving.  The pre-existing regulatory framework did not contemplate many of the products and technologies which are becoming available with p...
    Speaker: Neil Belson
    Presented at: Precision Medicine Virtual Event Series 2018
    3
    JUN 20, 2018 | 7:00 AM
    Utilizing Same-Day Sepsis Pathogen ID for Faster Therapy, Enhanced Stewardship, Improved Outcomes
    Utilizing Same-Day Sepsis Pathogen ID for Faster Therapy, Enhanced...
    DATE: June 20, 2018TIME: 07:00AM PDT, 10:00AM EDTIntroducing GE’s New Lyo-StableTM service. Sepsis is one of the top challenges facing hospitals in terms of clinical outcomes...
    Speaker: Cornelius Clancy, MD
    Sponsored By: T2 Biosystems, Inc.
    9 4
    MAY 30, 2018 | 7:30 AM
    Keynote Presentation: Robotic Automation of Human Cell Culture for Regenerative and Reparative Medicine
    Keynote Presentation: Robotic Automation of Human Cell Culture...
    Growing living human cells in vitro for basic research, drug discovery and reparative/regenerative medicine is challenged by the difficulty in developing methods for reproducibly and cost eff...
    Speaker: Robin Felder, PhD
    Presented at: Lab Automation Virtual Event Series 2018
    3
    MAY 10, 2018 | 12:00 PM
    C.E. CREDITS
    Precision Medicine and Pharmacogenomics in Community Pharmacy and Primary Care Setting
    Precision Medicine and Pharmacogenomics in Community Pharmacy...
    To provide insight on the utility and practicality of implementing a pharmacist-driven pharmacogenomics program in a community pharmacy or primary care setting and to provide a clinical updat...
    Speaker: Amina Abubakar, PharmD, AAHIVP
    Presented at: Genetics and Genomics Virtual Event Series 2018
    2
    APR 11, 2018 | 10:30 AM
    Medicare's New National Coverage Determination for Next Generation Sequencing: What Does it Mean for Diagnostic Laboratories?
    Medicare's New National Coverage Determination for Next Generation...
    On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) for the use of Next Generation Sequencing (NGS) for tumor profiling i...
    Speaker: Roger Klein MD, JD, FCAP
    Presented at: Molecular Diagnostics Virtual Event Series 2018
    1
     
     
  • APR 11, 2018 | 7:30 AM
    Keynote Presentation: A Regulatory Perspective on Molecular Diagnostic Devices
    Keynote Presentation: A Regulatory Perspective on Molecular Diagnostic...
    Advancements and innovation in in vitro diagnostic device (IVD) development are important for the success of personalized medicine. This is highlighted by the dramatic increase in the number...
    Speaker: Eunice Lee, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2018
    15 2
    APR 04, 2018 | 8:00 AM
    Reducing Human Errors in Pharmaceutical Manufacturing QC
    Reducing Human Errors in Pharmaceutical Manufacturing QC
    A recent report by CPhI highlights the pharmaceutical industry drive to improve productivity by improving right first time quality and reducing overhead costs1. Another report indicates that...
    Speaker: Tony Harrison
    Sponsored By: Beckman Coulter Life Sciences
    7 3
    MAR 29, 2018 | 1:30 PM
    Global Cannabis Regulation and Testing Standards
    Global Cannabis Regulation and Testing Standards
    For a plant that has been legal in some states for over 20 years, there has been an attitude that “cannabis never killed anyone.” While we don’t have the necessary rese...
    Speaker: Donald Land, PhD
    Presented at: Cannabis Sciences Virtual Event Series 2018
    4
    MAR 28, 2018 | 9:00 AM
    Drug Development and Approval in the U.S.: Regulatory Challenges and Opportunities for Cannabis Therapies
    Drug Development and Approval in the U.S.: Regulatory Challenges...
    Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for thera...
    Speaker: Emily Leongini
    Presented at: Cannabis Sciences Virtual Event Series 2018
    1
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