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    Drug Safety

    Drug Safety: involves management such as conducting clinical trials, medical supervision, keeping a check on all the applicable regulations and SOPs (Standard Operating Procedures). Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

    Webinars

    • NOV 17, 2016 | 1:00 PM
      Initiatives to advance stem cell science and medicine at California's $3 billion stem cell agency
      Initiatives to advance stem cell science and medicine at California's...
      The mission of the California Institute for Regenerative Medicine (CIRM) is to accelerate stem cell treatments to patients with unmet medical needs.  With $3 billion in funding and 300 a...
      Speaker: Stephen Lin, PhD
      Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
      4
      NOV 09, 2016 | 9:00 AM
      A duplexed assay to measure GPCR-mediated calcium signaling and β-Arrestin recruitment from single well using FDSS/µCell functional screening system
      A duplexed assay to measure GPCR-mediated calcium signaling and...
      DATE: November 9th, 2016 TIME: 9:00 AM PT, 12:00 PM ET The screening and functional characterization of novel ligands for G-Protein Coupled Receptors (GPCR) remains a key focus in drug di...
      Speaker: Thierry Calmels, PhD
      Sponsored By: DiscoverX, DiscoverX
      3
      NOV 03, 2016 | 9:00 AM
      Risk Mitigation and Management to ensure Virus Safety of Biopharmaceuticals: Regulatory Perspectives and Industry Best Practices
      Risk Mitigation and Management to ensure Virus Safety of Biopharmaceuticals:...
      DATE: November 3, 2016 TIME:  9:00AM PT, 12:00PM ET Patient safety is at the core of biopharmaceutical manufacturing operations. Ensuring virus safety of biopharmaceutical products p...
      Speaker: Hazel Aranha, PhD, RAC
      Sponsored By: Sartorius, Sartorius
      6
      AUG 30, 2016 | 8:00 AM
      Disease modeling in pluripotent stem cell-derived cardiomyocytes
      Disease modeling in pluripotent stem cell-derived cardiomyocytes
      Over the last 15 years, human pluripotent stem cell (hPSC) technologies have progressed from academic curiosities into tools with the promise to underpin commerce, leading to real progress in...
      Speaker: Chris Denning, PhD
      Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
      2
      JUL 13, 2016 | 7:30 AM
      The Great Debate: Surviving the Industry Storm
      The Great Debate: Surviving the Industry Storm
      There is no debating that a storm is approaching in our industry and it will have long lasting impacts on NPS, our customers and the patients we all work to serve. We all take these changes a...
      Speaker: Erin Summers , Karen Hough , Bill Bartelson , Aaron Lynch , David Pellicciarini
      Presented at: FY17 virtual National Field Meeting: Delivering the future. Changing lives.
      0
      MAY 25, 2016 | 8:00 AM
      Novel applications of automated electrophysiology in ion channel drug discovery
      Novel applications of automated electrophysiology in ion channel...
      DATE:  May 25, 2016 TIME:  8am Pacific time, 11am Eastern time, 4pm UK time, 5pm European time, 11pm Beijing time In this two-part webinar, we will be presenting the following t...
      Speaker: David Wei, PhD , Rok Cerne, MD, PhD
      Sponsored By: Molecular Devices, Molecular Devices
      4 1
      MAY 11, 2016 | 12:00 PM
      C.E. CREDITS
      The FDA's experience with emerging genomics technologies - past, present and future
      The FDA's experience with emerging genomics technologies - past,...
      Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
      Speaker: Weida Tong, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2016
      2
      APR 07, 2016 | 1:30 PM
      Introduction to exosomes and other extracellular vesicles the "the bodies molecular internet" for personalized & precision medicine.
      Introduction to exosomes and other extracellular vesicles the...
      A recently discovered communication system used by cells to send messages across the human body promises to revolutionize our understanding of disease and how we treat it. Technologies based...
      Speaker: Rey Magana
      Presented at: Molecular Diagnostics Virtual Event Series 2016
      2 1
      APR 07, 2016 | 7:30 AM
      Evidence Required by FDA for Establishing Clinical Validity
      Evidence Required by FDA for Establishing Clinical Validity
      In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests.  The legal bar passed by congress in...
      Speaker: Alberto Gutierrez, PhD
      Presented at: Molecular Diagnostics Virtual Event Series 2016
      2
      FEB 24, 2016 | 12:00 PM
      G-DOC Plus: A Data Science Platform for Precision Medicine Research
      G-DOC Plus: A Data Science Platform for Precision Medicine Research
      The advent of the microarray technology in 2000 has paved the way for advanced translational research methods that use molecular markers such as microRNA, proteins, metabolites and copy numbe...
      Speaker: Subha Madhavan, PhD
      Presented at: Precision Medicine Virtual Event Series 2016
      2
      FEB 04, 2016 | 6:00 AM
      Zebrafish: an upswing model in research and the need for refinement of anaesthesia
      Zebrafish: an upswing model in research and the need for refinement...
           In the last decade the number of publications in zebrafish tripled, from 938 in 2005 to 2432 in 2015 (Pubmed database; keyword: “zebrafish” in Title/Abstract;...
      Speaker: Ana Valentim, PhD
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      2
      FEB 03, 2016 | 3:00 PM
      Critical Appraisal of Animal Studies
      Critical Appraisal of Animal Studies
      Understanding systematic biases in primary research are important for appropriate interpretation of research and recognizing features of reproducible research. Systematic biases arise from th...
      Speaker: Annette O'Connor, BVSc, MVSc, DVSc, FACVSc
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      2
      FEB 03, 2016 | 6:00 AM
      Creating the Right Animal Program to Facilitate Quality Animal Studies. The AAALAC International Perspective
      Creating the Right Animal Program to Facilitate Quality Animal...
      Quality animal research is based on quality animal care and use. This is achieved by coordinating several key personnel and activities, and implementing appropriate animal care and use proced...
      Speaker: Javier Guillen, DVM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      3
      FEB 03, 2016 | 6:00 AM
      From the 3Rs to Systematic Reviews
      From the 3Rs to Systematic Reviews
      Why did we change focus from the 3Rs to Systematic Reviews? Questionnaires on the 3Rs have revealed that the 3R search gets no high priority and the 3R search process is never included in fun...
      Speaker: Merel Ritskes-Hoitinga, DVM, PhD, Animal Welfare Officer, Dipl ECLAM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2016
      4
      NOV 12, 2015 | 10:30 AM
      Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers: FDA perspective
      Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers:...
      Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used...
      Speaker: Doug Jeffery, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      2
      NOV 11, 2015 | 9:00 AM
      Keynote: FDA's Proposed Framework for Regulatory Oversight of Laboratory Developed Tests
      Keynote: FDA's Proposed Framework for Regulatory Oversight of...
      FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.  This use of “enforcement discretion” has been un...
      Speaker: Katherine (Katie) Serrano
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
      2
      OCT 07, 2015 | 9:00 AM
      Advancing neuroscience: functional insights from in vitro microelectrode arrays
      Advancing neuroscience: functional insights from in vitro microelectrode...
      DATE: October 7th, 2015TIME: 9am Pacific time, 12pm Eastern timeThe neuroscience field is rapidly evolving as both a burgeoning area for basic research (Parkinson’s, Alzheimer’s, ...
      Speaker: Carol Marchetto, PhD , John Graef, PhD , Daniel Millard, PhD
      Sponsored By: Axion BioSystems, Axion BioSystems
      5
      SEP 16, 2015 | 12:00 PM
      Developing Accurate Nanomedicines: The BIND Therapeutics Approach
      Developing Accurate Nanomedicines: The BIND Therapeutics Approach
      Nanotechnology, the engineering and manufacture of materials at the atomic and molecular scale, is used at BIND Therapeutics to develop novel Accurinâ„¢ nanomedicines that utilize cytotoxic age...
      Speaker: Hagop Youssoufian
      Presented at: C&EN's Virtual Symposium: Advances in Drug Discovery and Development
      2
      SEP 03, 2015 | 1:30 PM
      Challenges of Natural Preservative Application
      Challenges of Natural Preservative Application
      Natural preservation is often cited as effective and “safe” alternative to traditional synthetic preservative systems. However, the so-called natural preservatives bring a number...
      Speaker: Philip Geis, PhD
      Presented at: Microbiology Virtual Event Series 2015
      2 1
      JUL 22, 2015 | 9:00 AM
      WEBINAR: Investigative in vitro Drug Toxicology with Human iPSC-derived Cardiomyocytes
      WEBINAR: Investigative in vitro Drug Toxicology with Human iPSC-derived...
      DATE: July 22, 2015TIME: 9:00AM PT, 12:00PM ETHuman induced pluripotent stem cells (iPSCs) bring human biology into pre-clinical aspects of drug discovery. iPSC-derived cardiomyocytes have em...
      Speaker: Blake Anson, PhD , Mathew Brock, PhD
      Sponsored By: Cellular Dynamics, Cellular Dynamics
      10 1
      MAR 19, 2015 | 6:00 AM
      Nobel Prize Winner presents: Clinical Studies of a Candidate Drug (OSU6162) Capable of Alleviating Dysregulation of the Dopaminergic System
      Nobel Prize Winner presents: Clinical Studies of a Candidate Drug...
      This presentation will include both preclinical and small clinical studies with details on mechanism of action, safety and efficacy of a candidate drug that has the capability of alleviating...
      Speaker: Arvid Carlsson, MD, PhD
      Presented at: Neuroscience Virtual Event Series 2015
      12
      FEB 04, 2015 | 9:00 AM
      C.E. CREDITS
      Keynote: Applying Principles of Biosafety in Laboratory Animal Facilities
      Keynote: Applying Principles of Biosafety in Laboratory Animal...
      Some commonly accepted principles of biosafety include the strict adherence to standard laboratory practices and techniques, the use of safety equipment such as primary barriers and personal...
      Speaker: James R Swearengen, DVM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2015
      14
      FEB 04, 2015 | 7:30 AM
      C.E. CREDITS
      Transportation of Lab Animals - Threats from and Solutions to Animal Extremism interference
      Transportation of Lab Animals - Threats from and Solutions to...
      The transportation of laboratory animals is a critical step in obtaining the proper strain of animal that best fits the researchers needs. Animal Extremist groups have made this transportati...
      Speaker: Ted Wasky
      Presented at: Laboratory Animal Sciences Virtual Event Series 2015
      4
      FEB 04, 2015 | 6:00 AM
      C.E. CREDITS
      PCR testing in rodent health monitoring program: where are we exactly?
      PCR testing in rodent health monitoring program: where are we...
      Soiled-bedding sentinels are not always efficient in detecting pathogens in rodent colonies. In this context, PCR-based testing can be more sensitive and is being advocated as adjunct to trad...
      Speaker: Mathias Leblanc, DVM, PhD, DES, DACLAM
      Presented at: Laboratory Animal Sciences Virtual Event Series 2015
      33
    NOV 17, 2016 | 1:00 PM
    Initiatives to advance stem cell science and medicine at California's $3 billion stem cell agency
    Initiatives to advance stem cell science and medicine at California's...
    The mission of the California Institute for Regenerative Medicine (CIRM) is to accelerate stem cell treatments to patients with unmet medical needs.  With $3 billion in funding and 300 a...
    Speaker: Stephen Lin, PhD
    Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
    4
    NOV 09, 2016 | 9:00 AM
    A duplexed assay to measure GPCR-mediated calcium signaling and β-Arrestin recruitment from single well using FDSS/µCell functional screening system
    A duplexed assay to measure GPCR-mediated calcium signaling and...
    DATE: November 9th, 2016 TIME: 9:00 AM PT, 12:00 PM ET The screening and functional characterization of novel ligands for G-Protein Coupled Receptors (GPCR) remains a key focus in drug di...
    Speaker: Thierry Calmels, PhD
    Sponsored By: DiscoverX, DiscoverX
    3
    NOV 03, 2016 | 9:00 AM
    Risk Mitigation and Management to ensure Virus Safety of Biopharmaceuticals: Regulatory Perspectives and Industry Best Practices
    Risk Mitigation and Management to ensure Virus Safety of Biopharmaceuticals:...
    DATE: November 3, 2016 TIME:  9:00AM PT, 12:00PM ET Patient safety is at the core of biopharmaceutical manufacturing operations. Ensuring virus safety of biopharmaceutical products p...
    Speaker: Hazel Aranha, PhD, RAC
    Sponsored By: Sartorius, Sartorius
    6
    AUG 30, 2016 | 8:00 AM
    Disease modeling in pluripotent stem cell-derived cardiomyocytes
    Disease modeling in pluripotent stem cell-derived cardiomyocytes
    Over the last 15 years, human pluripotent stem cell (hPSC) technologies have progressed from academic curiosities into tools with the promise to underpin commerce, leading to real progress in...
    Speaker: Chris Denning, PhD
    Presented at: 4th Annual 24 Hours of Stem Cellsâ„¢ virtual event
    2
    JUL 13, 2016 | 7:30 AM
    The Great Debate: Surviving the Industry Storm
    The Great Debate: Surviving the Industry Storm
    There is no debating that a storm is approaching in our industry and it will have long lasting impacts on NPS, our customers and the patients we all work to serve. We all take these changes a...
    Speaker: Erin Summers , Karen Hough , Bill Bartelson , Aaron Lynch , David Pellicciarini
    Presented at: FY17 virtual National Field Meeting: Delivering the future. Changing lives.
    0
     
     
  • MAY 25, 2016 | 8:00 AM
    Novel applications of automated electrophysiology in ion channel drug discovery
    Novel applications of automated electrophysiology in ion channel...
    DATE:  May 25, 2016 TIME:  8am Pacific time, 11am Eastern time, 4pm UK time, 5pm European time, 11pm Beijing time In this two-part webinar, we will be presenting the following t...
    Speaker: David Wei, PhD , Rok Cerne, MD, PhD
    Sponsored By: Molecular Devices, Molecular Devices
    4 1
    MAY 11, 2016 | 12:00 PM
    C.E. CREDITS
    The FDA's experience with emerging genomics technologies - past, present and future
    The FDA's experience with emerging genomics technologies - past,...
    Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
    Speaker: Weida Tong, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2016
    2
    APR 07, 2016 | 1:30 PM
    Introduction to exosomes and other extracellular vesicles the "the bodies molecular internet" for personalized & precision medicine.
    Introduction to exosomes and other extracellular vesicles the...
    A recently discovered communication system used by cells to send messages across the human body promises to revolutionize our understanding of disease and how we treat it. Technologies based...
    Speaker: Rey Magana
    Presented at: Molecular Diagnostics Virtual Event Series 2016
    2 1
    APR 07, 2016 | 7:30 AM
    Evidence Required by FDA for Establishing Clinical Validity
    Evidence Required by FDA for Establishing Clinical Validity
    In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests.  The legal bar passed by congress in...
    Speaker: Alberto Gutierrez, PhD
    Presented at: Molecular Diagnostics Virtual Event Series 2016
    2
    FEB 24, 2016 | 12:00 PM
    G-DOC Plus: A Data Science Platform for Precision Medicine Research
    G-DOC Plus: A Data Science Platform for Precision Medicine Research
    The advent of the microarray technology in 2000 has paved the way for advanced translational research methods that use molecular markers such as microRNA, proteins, metabolites and copy numbe...
    Speaker: Subha Madhavan, PhD
    Presented at: Precision Medicine Virtual Event Series 2016
    2
     
     
  • FEB 04, 2016 | 6:00 AM
    Zebrafish: an upswing model in research and the need for refinement of anaesthesia
    Zebrafish: an upswing model in research and the need for refinement...
         In the last decade the number of publications in zebrafish tripled, from 938 in 2005 to 2432 in 2015 (Pubmed database; keyword: “zebrafish” in Title/Abstract;...
    Speaker: Ana Valentim, PhD
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    2
    FEB 03, 2016 | 3:00 PM
    Critical Appraisal of Animal Studies
    Critical Appraisal of Animal Studies
    Understanding systematic biases in primary research are important for appropriate interpretation of research and recognizing features of reproducible research. Systematic biases arise from th...
    Speaker: Annette O'Connor, BVSc, MVSc, DVSc, FACVSc
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    2
    FEB 03, 2016 | 6:00 AM
    Creating the Right Animal Program to Facilitate Quality Animal Studies. The AAALAC International Perspective
    Creating the Right Animal Program to Facilitate Quality Animal...
    Quality animal research is based on quality animal care and use. This is achieved by coordinating several key personnel and activities, and implementing appropriate animal care and use proced...
    Speaker: Javier Guillen, DVM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    3
    FEB 03, 2016 | 6:00 AM
    From the 3Rs to Systematic Reviews
    From the 3Rs to Systematic Reviews
    Why did we change focus from the 3Rs to Systematic Reviews? Questionnaires on the 3Rs have revealed that the 3R search gets no high priority and the 3R search process is never included in fun...
    Speaker: Merel Ritskes-Hoitinga, DVM, PhD, Animal Welfare Officer, Dipl ECLAM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2016
    4
    NOV 12, 2015 | 10:30 AM
    Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers: FDA perspective
    Validation of Mass Spec Analytical Platforms and Proteomic Biomarkers:...
    Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used...
    Speaker: Doug Jeffery, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    2
     
     
  • NOV 11, 2015 | 9:00 AM
    Keynote: FDA's Proposed Framework for Regulatory Oversight of Laboratory Developed Tests
    Keynote: FDA's Proposed Framework for Regulatory Oversight of...
    FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.  This use of “enforcement discretion” has been un...
    Speaker: Katherine (Katie) Serrano
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2015
    2
    OCT 07, 2015 | 9:00 AM
    Advancing neuroscience: functional insights from in vitro microelectrode arrays
    Advancing neuroscience: functional insights from in vitro microelectrode...
    DATE: October 7th, 2015TIME: 9am Pacific time, 12pm Eastern timeThe neuroscience field is rapidly evolving as both a burgeoning area for basic research (Parkinson’s, Alzheimer’s, ...
    Speaker: Carol Marchetto, PhD , John Graef, PhD , Daniel Millard, PhD
    Sponsored By: Axion BioSystems, Axion BioSystems
    5
    SEP 16, 2015 | 12:00 PM
    Developing Accurate Nanomedicines: The BIND Therapeutics Approach
    Developing Accurate Nanomedicines: The BIND Therapeutics Approach
    Nanotechnology, the engineering and manufacture of materials at the atomic and molecular scale, is used at BIND Therapeutics to develop novel Accurinâ„¢ nanomedicines that utilize cytotoxic age...
    Speaker: Hagop Youssoufian
    Presented at: C&EN's Virtual Symposium: Advances in Drug Discovery and Development
    2
    SEP 03, 2015 | 1:30 PM
    Challenges of Natural Preservative Application
    Challenges of Natural Preservative Application
    Natural preservation is often cited as effective and “safe” alternative to traditional synthetic preservative systems. However, the so-called natural preservatives bring a number...
    Speaker: Philip Geis, PhD
    Presented at: Microbiology Virtual Event Series 2015
    2 1
    JUL 22, 2015 | 9:00 AM
    WEBINAR: Investigative in vitro Drug Toxicology with Human iPSC-derived Cardiomyocytes
    WEBINAR: Investigative in vitro Drug Toxicology with Human iPSC-derived...
    DATE: July 22, 2015TIME: 9:00AM PT, 12:00PM ETHuman induced pluripotent stem cells (iPSCs) bring human biology into pre-clinical aspects of drug discovery. iPSC-derived cardiomyocytes have em...
    Speaker: Blake Anson, PhD , Mathew Brock, PhD
    Sponsored By: Cellular Dynamics, Cellular Dynamics
    10 1
     
     
  • MAR 19, 2015 | 6:00 AM
    Nobel Prize Winner presents: Clinical Studies of a Candidate Drug (OSU6162) Capable of Alleviating Dysregulation of the Dopaminergic System
    Nobel Prize Winner presents: Clinical Studies of a Candidate Drug...
    This presentation will include both preclinical and small clinical studies with details on mechanism of action, safety and efficacy of a candidate drug that has the capability of alleviating...
    Speaker: Arvid Carlsson, MD, PhD
    Presented at: Neuroscience Virtual Event Series 2015
    12
    FEB 04, 2015 | 9:00 AM
    C.E. CREDITS
    Keynote: Applying Principles of Biosafety in Laboratory Animal Facilities
    Keynote: Applying Principles of Biosafety in Laboratory Animal...
    Some commonly accepted principles of biosafety include the strict adherence to standard laboratory practices and techniques, the use of safety equipment such as primary barriers and personal...
    Speaker: James R Swearengen, DVM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2015
    14
    FEB 04, 2015 | 7:30 AM
    C.E. CREDITS
    Transportation of Lab Animals - Threats from and Solutions to Animal Extremism interference
    Transportation of Lab Animals - Threats from and Solutions to...
    The transportation of laboratory animals is a critical step in obtaining the proper strain of animal that best fits the researchers needs. Animal Extremist groups have made this transportati...
    Speaker: Ted Wasky
    Presented at: Laboratory Animal Sciences Virtual Event Series 2015
    4
    FEB 04, 2015 | 6:00 AM
    C.E. CREDITS
    PCR testing in rodent health monitoring program: where are we exactly?
    PCR testing in rodent health monitoring program: where are we...
    Soiled-bedding sentinels are not always efficient in detecting pathogens in rodent colonies. In this context, PCR-based testing can be more sensitive and is being advocated as adjunct to trad...
    Speaker: Mathias Leblanc, DVM, PhD, DES, DACLAM
    Presented at: Laboratory Animal Sciences Virtual Event Series 2015
    33
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