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    Safety Assessment

    Safety Assessment: like risk assessment, is the process of characterizing the nature and likelihood of a harmful effect to individuals or populations from certain human activities.

    Webinars

    • FEB 24, 2021 | 9:00 AM
      Keynote Panel Presentation: Biomarker assays - bioanalytical meets CLIA
      Keynote Panel Presentation: Biomarker assays - bioanalytical meets...
      Reliable diagnostic, prognostic, predictive, pharmacodynamic, and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing, and monitoring. Being able to iden...
      Speaker: Andrew Roche, PhD , Roger Hayes, PhD
      Presented at: Drug Discovery & Development Virtual Event Series 2021
      1
      FEB 24, 2021 | 12:00 AM
      Evolution of a Platform-Based Non-Clinical Safety Assessment Approach for Vaccines
      Evolution of a Platform-Based Non-Clinical Safety Assessment Approach...
      Platform based therapeutics and vaccines offer a unique opportunity to simplify and streamline the drug development process. Moderna has taken the approach of harnessing the power of mRNA as...
      Speaker: Joseph J. Senn, PhD, DABT
      Presented at: Drug Discovery & Development Virtual Event Series 2021
      2
      JAN 21, 2021 | 10:00 AM
      Applications of Procalcitonin-aided Decision Making for Antibiotic Stewardship in Emergency Care
      Applications of Procalcitonin-aided Decision Making for Antibiotic...
      Date: January 21, 2021 Time: 10:00am (PST) Abstract Learning Objectives Discuss Procalcitonin as a biomarker to help distinguish viral versus bacterial infection Review the literature suppor...
      Speaker: Larissa May
      Sponsored By: Thermo Fisher Scientific
      9 1
      NOV 19, 2020 | 3:00 PM
      Cost of Quality and the Medical Laboratory 2020
      Cost of Quality and the Medical Laboratory 2020
      Two aspects of the Cost of Quality are important in the medical laboratory—the theory behind the quality cost types and the application of those cost types to laboratory activities. Th...
      Speaker: Lucia M. Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE
      Presented at: A Bio-Rad Quality Control Virtual Conference
      15 7
      NOV 12, 2020 | 12:00 PM
      Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered and vaccinated individuals using a high-throughput and cost-effective test
      Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered...
      As many parts of the northern hemisphere move into the colder months and indoors, SARS CoV-2 has begun a second infection wave that has exceeded the first surge of cases in many global regio...
      Speaker: Sean Taylor, MBA, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      Sponsored By: GenScript
      2
      NOV 12, 2020 | 7:30 AM
      Keynote Presentation: Choosing Wisely lab utilization first steps: addressing the low hanging fruit
      Keynote Presentation: Choosing Wisely lab utilization first steps:...
      In 2012, the Choosing Wisely initiative was commenced by the ABIM with numerous societies putting forward lists of overused tests or procedures. The Choosing Wisely movement has spread to nu...
      Speaker: Jeannie Callum, BA, MD, FRCPC
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      1
      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
      NOV 12, 2020 | 12:00 AM
      Clinical utility of concussion injury biomarkers
      Clinical utility of concussion injury biomarkers
      Cases of traumatic brain injury (TBI) have been steadily rising over the past decade with most common causes of injury observed among participants in contact sports, combat military personne...
      Speaker: Paul R. Johnson, PhD, MT(ASCP), DABCC, FAACC
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
      1
      OCT 13, 2020 | 8:00 AM
      C.E. CREDITS
      WORLD THROMBOSIS DAY SPECIAL EVENT:  The Use of D-dimer as a Novel Biomarker in Venous Thromboembolic Disease for Hospitalized Medically Ill Patients
      WORLD THROMBOSIS DAY SPECIAL EVENT: The Use of D-dimer as a Novel...
      Learn how D-dimer testing aids VTE diagnosis, risk stratification, and PE prevention, with insights on medically ill and COVID-19 patients....
      Speaker: Alex Spyropoulos, MD, FACP, FCCP, FRCPC
      Presented at: Stago EdVantage Virtual University
      Sponsored By: Diagnostica Stago, Inc.
      14 1
      SEP 29, 2020 | 8:00 AM
      Microbial Quality Control in Manufacturing of Medicinal Products
      Microbial Quality Control in Manufacturing of Medicinal Products
      DATE: September 29, 2020 TIME: 8:00 am PDT There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized product...
      Speaker: Ziva Abraham
      Sponsored By: Sartorius
      19 5
      SEP 23, 2020 | 10:30 AM
      Practical Mass Cytometry
      Practical Mass Cytometry
      On measuring photons and ions: Impact on panel design, signal detection and data quality 10:30–11:00 am PDT Presented By: Tim Bushnell, PhD, MBA Monitoring immunotherapy with a mass cy...
      Speaker: Tim Bushnell, PhD, MBA , Gerd Haga Bringeland, MD, PhD , Greg Hopkins, BS
      Presented at: 9th Annual Fluidigm Mass Cytometry Virtual Summit
      2
      SEP 11, 2020 | 8:00 AM
      Implementing a World-Class Clinical Pharmacogenomics Service
      Implementing a World-Class Clinical Pharmacogenomics Service
      DATE: September 11, 2020 TIME: 08:00am PT, 11:00pm ET This is the third topic in the webinar series on ‘ Predictive Genomics for Population & Personalized Health ’. Pharmacog...
      Speaker: Dr. Hyun Kim
      Sponsored By: Thermo Fisher Scientific/Gibco
      8 2
      JUN 30, 2020 | 9:00 AM
      Quality Control for the Pharmaceutical Industry; Stage 3, Continued Verification, in the Lifecycle of Analytical Procedures
      Quality Control for the Pharmaceutical Industry; Stage 3, Continued...
      DATE: June 30, 2020 TIME: 9:00am PDT, 12:00pm EDT QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At t...
      Speaker: Jane Weitzel
      Sponsored By: Sartorius
      17 1
      MAY 20, 2020 | 1:15 PM
      Flotetuzumab, an Investigational CD123 x CD3 Bispecific Dart® Protein-Induced Clustering of CD3+ T Cells & CD123+ AML Cells in Bone Marrow Biopsies Is Associated with Response to Treatment...
      Flotetuzumab, an Investigational CD123 x CD3 Bispecific Dart®...
      Background: Acute myeloid leukemia (AML) is a molecularly and clinically heterogeneous hematological malignancy. Despite recent advancements in the treatment of AML, approximately 50% of pat...
      Speaker: Jan Davidson, MD, PhD
      Presented at: Advancing Science - A Virtual Oncology Conference
      1
      MAY 12, 2020 | 9:00 AM
      Analytical Quality Control for the Pharmaceutical Industry
      Analytical Quality Control for the Pharmaceutical Industry
      NEW DATE: Date: May 12, 2020 Time: 9:00am PDT, 12:00pm EDT...
      Speaker: Joy McElroy
      Sponsored By: Sartorius
      29 9
      APR 24, 2020 | 8:00 AM
      The International Council for Standardisation in Hematology (ICSH) recommendations for Hemostasis Critical Values, Tests, and Reporting - a stepwise description for the committee's decisions
      The International Council for Standardisation in Hematology (ICSH)...
      The International Council for Standardization in Haematology (ICSH) is a nonprofit organization dedicated to providing open-access guidance documents to enhance the quality of laboratory tes...
      Speaker: Bob Gosselin
      Sponsored By: Diagnostica Stago, Inc.
      10
      APR 22, 2020 | 8:00 AM
      C.E. CREDITS
      The NEW Coag Value Playbook...Embrace the Power of Local Testing
      The NEW Coag Value Playbook...Embrace the Power of Local Testing
      Discover strategies for labs to optimize coagulation testing, improve patient outcomes, and strengthen their role in clinical care teams....
      Speaker: Eleanor Herriman, MD, MBA , Oksana Volod, MD
      Presented at: Stago EdVantage Virtual University
      Sponsored By: Diagnostica Stago, Inc.
      7
      APR 20, 2020 | 8:00 AM
      C.E. CREDITS
      Emergency patient management using coagulation assays
      Emergency patient management using coagulation assays
      Explore emergency hemostasis testing approaches, from rapid lab assays to viscoelastic methods, for managing bleeding patients....
      Speaker: Wayne Chandler, MD
      Presented at: Stago EdVantage Virtual University
      Sponsored By: Diagnostica Stago, Inc.
      17 5
      MAR 25, 2020 | 6:00 AM
      Challenges to Starting a New Cannabis Lab: from Sample Traceability to Method Development to Data Management
      Challenges to Starting a New Cannabis Lab: from Sample Traceability...
      Setting up an analytical laboratory requires a clear objective and analytical resources, both instrumentation and technical. The four main areas of focus exist during this process: 1) Instru...
      Speaker: Matthew Brittain, PhD
      Presented at: Cannabis Sciences Virtual Event Series 2020
      1
      MAR 24, 2020 | 10:00 AM
      Save your time on data analysis with new Batch Analysis feature in Axon pCLAMP 11 Software
      Save your time on data analysis with new Batch Analysis feature...
      DATE: March 24, 2020 TIME: 10:00 am PDT, 1:00pm EDT The Clampfit software module is a useful tool to manipulate and analyze electrophysiological data acquired by pCLAMP™ software. Rece...
      Speaker: Jeffrey Tang, Ph.D.
      Sponsored By: Molecular Devices
      10
      MAR 05, 2020 | 9:00 AM
      An Update on H. pylori testing with a focus on the Houston Consensus recommendations
      An Update on H. pylori testing with a focus on the Houston Consensus...
      Recommendations for key factors in testing and diagnosis of H. pylori infections to include information on appropriate patients for H.pylori testing, current testing options, post treatment...
      Speaker: David Graham, MD
      8
      FEB 05, 2020 | 8:00 AM
      C.E. CREDITS
      Emerging Issues in the Coagulation Laboratory
      Emerging Issues in the Coagulation Laboratory
      Learn how new hemophilia and anticoagulant therapies impact coagulation assays and clinical decisions in our educational session....
      Speaker: Donna Castellone, MS, MASCP, MT(ASCP) SH
      Presented at: Stago EdVantage Virtual University
      Sponsored By: Diagnostica Stago, Inc.
      10 1
      JAN 14, 2020 | 9:00 AM
      Fecal Elastase-1 - a Biomarker for Pancreatic Exocrine Insufficiency
      Fecal Elastase-1 - a Biomarker for Pancreatic Exocrine Insufficiency
      Fecal elastase-1 – a biomarker for pancreatic exocrine insufficiency(EPI) continues to gain traction as an ideal biomarker for assessing EPI. This presentation will include a review of...
      Speaker: Roy Sherwood, BSc, MSC, DPhil
      Sponsored By: Diasorin S.p.A.
      5
      JAN 14, 2020 | 8:00 AM
      CiPA initiative and validation of high-throughput methods to characterize compound effects in human iPSC-derived cardiomyocytes
      CiPA initiative and validation of high-throughput methods to characterize...
      DATE: January 14, 2019 TIME: 8:00am PST Drug-induced QT interval prolongation and Torsades de Pointes (TdP) arrhythmias are the leading causes for drug withdrawals from market and compound a...
      Speaker: Muthukrishnan Renganathan, PhD , Panida Lertkiatmongkol, PhD , Oksana Sirenko, PhD , Carole Crittenden
      Sponsored By: Molecular Devices, Eurofins Discovery
      3
    FEB 24, 2021 | 9:00 AM
    Keynote Panel Presentation: Biomarker assays - bioanalytical meets CLIA
    Keynote Panel Presentation: Biomarker assays - bioanalytical meets...
    Reliable diagnostic, prognostic, predictive, pharmacodynamic, and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing, and monitoring. Being able to iden...
    Speaker: Andrew Roche, PhD , Roger Hayes, PhD
    Presented at: Drug Discovery & Development Virtual Event Series 2021
    1
    FEB 24, 2021 | 12:00 AM
    Evolution of a Platform-Based Non-Clinical Safety Assessment Approach for Vaccines
    Evolution of a Platform-Based Non-Clinical Safety Assessment Approach...
    Platform based therapeutics and vaccines offer a unique opportunity to simplify and streamline the drug development process. Moderna has taken the approach of harnessing the power of mRNA as...
    Speaker: Joseph J. Senn, PhD, DABT
    Presented at: Drug Discovery & Development Virtual Event Series 2021
    2
    JAN 21, 2021 | 10:00 AM
    Applications of Procalcitonin-aided Decision Making for Antibiotic Stewardship in Emergency Care
    Applications of Procalcitonin-aided Decision Making for Antibiotic...
    Date: January 21, 2021 Time: 10:00am (PST) Abstract Learning Objectives Discuss Procalcitonin as a biomarker to help distinguish viral versus bacterial infection Review the literature suppor...
    Speaker: Larissa May
    Sponsored By: Thermo Fisher Scientific
    9 1
    NOV 19, 2020 | 3:00 PM
    Cost of Quality and the Medical Laboratory 2020
    Cost of Quality and the Medical Laboratory 2020
    Two aspects of the Cost of Quality are important in the medical laboratory—the theory behind the quality cost types and the application of those cost types to laboratory activities. Th...
    Speaker: Lucia M. Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ)CMQ/OE
    Presented at: A Bio-Rad Quality Control Virtual Conference
    15 7
    NOV 12, 2020 | 12:00 PM
    Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered and vaccinated individuals using a high-throughput and cost-effective test
    Measuring levels of neutralizing antibodies in SARS CoV-2 infected/recovered...
    As many parts of the northern hemisphere move into the colder months and indoors, SARS CoV-2 has begun a second infection wave that has exceeded the first surge of cases in many global regio...
    Speaker: Sean Taylor, MBA, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    Sponsored By: GenScript
    2
     
     
  • NOV 12, 2020 | 7:30 AM
    Keynote Presentation: Choosing Wisely lab utilization first steps: addressing the low hanging fruit
    Keynote Presentation: Choosing Wisely lab utilization first steps:...
    In 2012, the Choosing Wisely initiative was commenced by the ABIM with numerous societies putting forward lists of overused tests or procedures. The Choosing Wisely movement has spread to nu...
    Speaker: Jeannie Callum, BA, MD, FRCPC
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    1
    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
    NOV 12, 2020 | 12:00 AM
    Clinical utility of concussion injury biomarkers
    Clinical utility of concussion injury biomarkers
    Cases of traumatic brain injury (TBI) have been steadily rising over the past decade with most common causes of injury observed among participants in contact sports, combat military personne...
    Speaker: Paul R. Johnson, PhD, MT(ASCP), DABCC, FAACC
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2020
    1
    OCT 13, 2020 | 8:00 AM
    C.E. CREDITS
    WORLD THROMBOSIS DAY SPECIAL EVENT:  The Use of D-dimer as a Novel Biomarker in Venous Thromboembolic Disease for Hospitalized Medically Ill Patients
    WORLD THROMBOSIS DAY SPECIAL EVENT: The Use of D-dimer as a Novel...
    Learn how D-dimer testing aids VTE diagnosis, risk stratification, and PE prevention, with insights on medically ill and COVID-19 patients....
    Speaker: Alex Spyropoulos, MD, FACP, FCCP, FRCPC
    Presented at: Stago EdVantage Virtual University
    Sponsored By: Diagnostica Stago, Inc.
    14 1
    SEP 29, 2020 | 8:00 AM
    Microbial Quality Control in Manufacturing of Medicinal Products
    Microbial Quality Control in Manufacturing of Medicinal Products
    DATE: September 29, 2020 TIME: 8:00 am PDT There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized product...
    Speaker: Ziva Abraham
    Sponsored By: Sartorius
    19 5
     
     
  • SEP 23, 2020 | 10:30 AM
    Practical Mass Cytometry
    Practical Mass Cytometry
    On measuring photons and ions: Impact on panel design, signal detection and data quality 10:30–11:00 am PDT Presented By: Tim Bushnell, PhD, MBA Monitoring immunotherapy with a mass cy...
    Speaker: Tim Bushnell, PhD, MBA , Gerd Haga Bringeland, MD, PhD , Greg Hopkins, BS
    Presented at: 9th Annual Fluidigm Mass Cytometry Virtual Summit
    2
    SEP 11, 2020 | 8:00 AM
    Implementing a World-Class Clinical Pharmacogenomics Service
    Implementing a World-Class Clinical Pharmacogenomics Service
    DATE: September 11, 2020 TIME: 08:00am PT, 11:00pm ET This is the third topic in the webinar series on ‘ Predictive Genomics for Population & Personalized Health ’. Pharmacog...
    Speaker: Dr. Hyun Kim
    Sponsored By: Thermo Fisher Scientific/Gibco
    8 2
    JUN 30, 2020 | 9:00 AM
    Quality Control for the Pharmaceutical Industry; Stage 3, Continued Verification, in the Lifecycle of Analytical Procedures
    Quality Control for the Pharmaceutical Industry; Stage 3, Continued...
    DATE: June 30, 2020 TIME: 9:00am PDT, 12:00pm EDT QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At t...
    Speaker: Jane Weitzel
    Sponsored By: Sartorius
    17 1
    MAY 20, 2020 | 1:15 PM
    Flotetuzumab, an Investigational CD123 x CD3 Bispecific Dart® Protein-Induced Clustering of CD3+ T Cells & CD123+ AML Cells in Bone Marrow Biopsies Is Associated with Response to Treatment...
    Flotetuzumab, an Investigational CD123 x CD3 Bispecific Dart®...
    Background: Acute myeloid leukemia (AML) is a molecularly and clinically heterogeneous hematological malignancy. Despite recent advancements in the treatment of AML, approximately 50% of pat...
    Speaker: Jan Davidson, MD, PhD
    Presented at: Advancing Science - A Virtual Oncology Conference
    1
    MAY 12, 2020 | 9:00 AM
    Analytical Quality Control for the Pharmaceutical Industry
    Analytical Quality Control for the Pharmaceutical Industry
    NEW DATE: Date: May 12, 2020 Time: 9:00am PDT, 12:00pm EDT...
    Speaker: Joy McElroy
    Sponsored By: Sartorius
    29 9
     
     
  • APR 24, 2020 | 8:00 AM
    The International Council for Standardisation in Hematology (ICSH) recommendations for Hemostasis Critical Values, Tests, and Reporting - a stepwise description for the committee's decisions
    The International Council for Standardisation in Hematology (ICSH)...
    The International Council for Standardization in Haematology (ICSH) is a nonprofit organization dedicated to providing open-access guidance documents to enhance the quality of laboratory tes...
    Speaker: Bob Gosselin
    Sponsored By: Diagnostica Stago, Inc.
    10
    APR 22, 2020 | 8:00 AM
    C.E. CREDITS
    The NEW Coag Value Playbook...Embrace the Power of Local Testing
    The NEW Coag Value Playbook...Embrace the Power of Local Testing
    Discover strategies for labs to optimize coagulation testing, improve patient outcomes, and strengthen their role in clinical care teams....
    Speaker: Eleanor Herriman, MD, MBA , Oksana Volod, MD
    Presented at: Stago EdVantage Virtual University
    Sponsored By: Diagnostica Stago, Inc.
    7
    APR 20, 2020 | 8:00 AM
    C.E. CREDITS
    Emergency patient management using coagulation assays
    Emergency patient management using coagulation assays
    Explore emergency hemostasis testing approaches, from rapid lab assays to viscoelastic methods, for managing bleeding patients....
    Speaker: Wayne Chandler, MD
    Presented at: Stago EdVantage Virtual University
    Sponsored By: Diagnostica Stago, Inc.
    17 5
    MAR 25, 2020 | 6:00 AM
    Challenges to Starting a New Cannabis Lab: from Sample Traceability to Method Development to Data Management
    Challenges to Starting a New Cannabis Lab: from Sample Traceability...
    Setting up an analytical laboratory requires a clear objective and analytical resources, both instrumentation and technical. The four main areas of focus exist during this process: 1) Instru...
    Speaker: Matthew Brittain, PhD
    Presented at: Cannabis Sciences Virtual Event Series 2020
    1
    MAR 24, 2020 | 10:00 AM
    Save your time on data analysis with new Batch Analysis feature in Axon pCLAMP 11 Software
    Save your time on data analysis with new Batch Analysis feature...
    DATE: March 24, 2020 TIME: 10:00 am PDT, 1:00pm EDT The Clampfit software module is a useful tool to manipulate and analyze electrophysiological data acquired by pCLAMP™ software. Rece...
    Speaker: Jeffrey Tang, Ph.D.
    Sponsored By: Molecular Devices
    10
     
     
  • MAR 05, 2020 | 9:00 AM
    An Update on H. pylori testing with a focus on the Houston Consensus recommendations
    An Update on H. pylori testing with a focus on the Houston Consensus...
    Recommendations for key factors in testing and diagnosis of H. pylori infections to include information on appropriate patients for H.pylori testing, current testing options, post treatment...
    Speaker: David Graham, MD
    8
    FEB 05, 2020 | 8:00 AM
    C.E. CREDITS
    Emerging Issues in the Coagulation Laboratory
    Emerging Issues in the Coagulation Laboratory
    Learn how new hemophilia and anticoagulant therapies impact coagulation assays and clinical decisions in our educational session....
    Speaker: Donna Castellone, MS, MASCP, MT(ASCP) SH
    Presented at: Stago EdVantage Virtual University
    Sponsored By: Diagnostica Stago, Inc.
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