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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

    • FEB 10, 2015 | 12:00 PM
      Primary HPV Cervical Cancer Screening: Supporting data and guidance updates
      Primary HPV Cervical Cancer Screening: Supporting data and guidance...
      Date: Tuesday, February 10th, 2015Time: 12:00PM PST, 3:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
      Speaker: Julia Engstrom-Melnyk, PhD
      Sponsored By: Roche Molecular Diagnostics, Roche Molecular Diagnostics
      8 5
      FEB 10, 2015 | 9:00 AM
      Primary HPV Cervical Cancer Screening: Supporting data and guidance updates
      Primary HPV Cervical Cancer Screening: Supporting data and guidance...
      Date: Tuesday, February 10th, 2015Time: 9:00AM PST, 12:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
      Speaker: Julia Engstrom-Melnyk, PhD
      Sponsored By: Roche Molecular Diagnostics, Roche Molecular Diagnostics
      10 24
      NOV 12, 2014 | 8:00 AM
      Hallmarks of cancer - Detect and quantify cell death signatures with high content imaging
      Hallmarks of cancer - Detect and quantify cell death signatures...
      Dr. Oliver Kepp will be presenting on:Immunogenic cell death fingerprinting utilizing a high-throughput screening approachThe strategy of immunogenic cell death fingerprinting has been design...
      Speaker: Oliver Kepp, PhD and Jayne A. Hesley
      Sponsored By: Molecular Devices, Molecular Devices
      33
      OCT 29, 2014 | 9:00 AM
      What's wrong with biomarker development for cancer
      What's wrong with biomarker development for cancer
      Although robust and clinically meaningful biomarkers are key to achieving the current vision for precision (molecularly based), cancer medicine (patient stratification, early diagnosis, drug...
      Speaker: Anna Barker, PhD
      Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2014
      10
      MAY 28, 2014 | 1:30 PM
      Legal and Regulatory Developments Affecting Molecular Testing
      Legal and Regulatory Developments Affecting Molecular Testing
      The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by...
      Speaker: Peter M Kazon, JD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
      14
      MAY 28, 2014 | 10:30 AM
      Heavy/Light Chain Combination Assays: What Laboratories should know about M-Protein detection
      Heavy/Light Chain Combination Assays: What Laboratories should...
      Traditional testing methods for monoclonal protein in Plasma Cell Dyscrasias correctly identify a majority of patients. However, limitations in these methods can cause patients to be missed...
      Speaker: Richard O'Hara, PhD
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
      87
      MAY 28, 2014 | 6:00 AM
      How to Improve Healthcare with More Effective Clinical Laboratory Test Utilization
      How to Improve Healthcare with More Effective Clinical Laboratory...
      Due to the large increase in the number and complexity of clinical laboratory tests, optimal use of laboratory testing services has presented many challenges. The Clinical Laboratory Integrat...
      Speaker: Julie R Taylor, PhD, MS
      Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
      184
      MAR 19, 2014 | 9:00 AM
      Remyelinating the adult central nervous system: Repairing injury in  MS
      Remyelinating the adult central nervous system: Repairing injury...
      Multiple Sclerosis is a debilitating neurodegnerative disease of the central nervous system in which the immune system targets and destroys myelin sheaths surrounding axons. Progressive a...
      Speaker: Ari Green, MD
      Presented at: Neuroscience Virtual Event Series 2014
      0
      MAR 19, 2014 | 7:00 AM
      Therapeutic Strategies for Cognitive Dysfunction in Down Syndrome
      Therapeutic Strategies for Cognitive Dysfunction in Down Syndrome
      Down syndrome (DS) is a complex multi-system disorder affecting more than 5.8 million individuals around the world and it causes significant physical, psychological, and cognitive abnormaliti...
      Speaker: Ahmad Salehi, MD, PhD
      Presented at: Neuroscience Virtual Event Series 2014
      15
      FEB 05, 2014 | 5:00 PM
      C.E. CREDITS
      Veterinary treatment approaches to common clinical signs in toxicology setting
      Veterinary treatment approaches to common clinical signs in toxicology...
      This presentation mainly includes 4 sections, the first one: introduction for CFDA/FDA GLP Regulation and analysis the difference. The second one: introduction of the most important responsi...
      Speaker: Xueying Pan, MS, PhD Candidate
      Presented at: Laboratory Animal Sciences Virtual Event Series 2014
      10
      FEB 05, 2014 | 3:00 PM
      C.E. CREDITS
      Measuring Teaching - Metrics applied to training in lab animal sciences
      Measuring Teaching - Metrics applied to training in lab animal...
      The title of this presentation could have been Training within laboratory animal science - where we are and where we should be. While training has been the domain of facility managers for ma...
      Speaker: Bruce W Kennedy, MS RLATG CMAR CPIA
      Presented at: Laboratory Animal Sciences Virtual Event Series 2014
      28
      NOV 20, 2013 | 8:00 AM
      A comparison of genotyping platforms for pharmacogenetic testing
      A comparison of genotyping platforms for pharmacogenetic testing
      As the scientific evidence base for pharmacogenetics continues to expand, the use of such information in clinical management and drug development will be in demand. The FDA advises that the...
      Speaker: Mark Borgman, PhD
      Presented at: Advanced Genomics in Clinical and Translational Research - Fall
      210
      OCT 17, 2013 | 9:00 AM
      C.E. CREDITS
      Subtyping Circulating Tumor Cells in Breast Cancer for Personalized Therapeutics
      Subtyping Circulating Tumor Cells in Breast Cancer for Personalized...
      Cancer metastases develop when tumor cells known as circulating tumor cells (CTCs) are shed from a tumor, circulate through the blood stream and colonize a distant tissue. The number of CTCs...
      Speaker: Lori M. Millner, PhD
      Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2013
      86
      OCT 16, 2013 | 2:00 PM
      C.E. CREDITS
      PSA Screening and Early Detection for Prostate Cancer 2013: Controversy and Opportunity
      PSA Screening and Early Detection for Prostate Cancer 2013: Controversy...
      While the Prostate Specific Antigen (PSA) blood test has been available since 1986 and FDA-approved for the early detection of prostate cancer since the early 1990s, 2012 marked a critical in...
      Speaker: Judd W Moul, MD, FACS
      Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2013
      80
      OCT 16, 2013 | 10:00 AM
      C.E. CREDITS
      Keynote: Is Personalized (Molecularly-Based) Medicine our Best Hope to Finally Defeat Cancer?
      Keynote: Is Personalized (Molecularly-Based) Medicine our Best...
      The current paradigm of detecting established cancer (often too late) and treating routinely with cytotoxic drugs is beginning to change. Advanced technologies such as whole genome sequencin...
      Speaker: Anna Barker, PhD
      Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2013
      37
      AUG 22, 2013 | 3:00 PM
      C.E. CREDITS
      Evaluation challenges and regulatory considerations for next-generation sequencing and other high throughput genomic technology based clinical applications
      Evaluation challenges and regulatory considerations for next-generation...
      The use of ultrahigh throughput diagnostic tests that determine genetic sequence variation to guide patient care is rapidly expanding, fueled by the enormous growth in sequencing platform dev...
      Speaker: Živana Težak, PhD
      Presented at: Genetics and Genomics Virtual Event Series 2013
      282
      AUG 21, 2013 | 8:00 AM
      C.E. CREDITS
      Clinical Applications in Pharmacogenetics
      Clinical Applications in Pharmacogenetics
      As a component of individualized medicine, pharmacogenetics (PGx) focuses on how genetic factors influence individual responses to specific medications. The clinical goals of pharmacogenetics...
      Speaker: Linnea Baudhuin, PhD, DABMG
      Presented at: Genetics and Genomics Virtual Event Series 2013
      71
      MAY 30, 2013 | 8:00 AM
      VITROS® Microslide Technologies / Assays
      VITROS® Microslide Technologies / Assays
      VITROS® Microslides utilize a layered, dry-slide technology that enables separate reaction domains such that each step can be optimized to provide excellent assay performance. Excellent preci...
      Speaker: John Backus, PhD
      Presented at: Clinical Diagnostics Virtual Event Series 2013
      51
    FEB 10, 2015 | 12:00 PM
    Primary HPV Cervical Cancer Screening: Supporting data and guidance updates
    Primary HPV Cervical Cancer Screening: Supporting data and guidance...
    Date: Tuesday, February 10th, 2015Time: 12:00PM PST, 3:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
    Speaker: Julia Engstrom-Melnyk, PhD
    Sponsored By: Roche Molecular Diagnostics, Roche Molecular Diagnostics
    8 5
    FEB 10, 2015 | 9:00 AM
    Primary HPV Cervical Cancer Screening: Supporting data and guidance updates
    Primary HPV Cervical Cancer Screening: Supporting data and guidance...
    Date: Tuesday, February 10th, 2015Time: 9:00AM PST, 12:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
    Speaker: Julia Engstrom-Melnyk, PhD
    Sponsored By: Roche Molecular Diagnostics, Roche Molecular Diagnostics
    10 24
    NOV 12, 2014 | 8:00 AM
    Hallmarks of cancer - Detect and quantify cell death signatures with high content imaging
    Hallmarks of cancer - Detect and quantify cell death signatures...
    Dr. Oliver Kepp will be presenting on:Immunogenic cell death fingerprinting utilizing a high-throughput screening approachThe strategy of immunogenic cell death fingerprinting has been design...
    Speaker: Oliver Kepp, PhD and Jayne A. Hesley
    Sponsored By: Molecular Devices, Molecular Devices
    33
    OCT 29, 2014 | 9:00 AM
    What's wrong with biomarker development for cancer
    What's wrong with biomarker development for cancer
    Although robust and clinically meaningful biomarkers are key to achieving the current vision for precision (molecularly based), cancer medicine (patient stratification, early diagnosis, drug...
    Speaker: Anna Barker, PhD
    Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2014
    10
    MAY 28, 2014 | 1:30 PM
    Legal and Regulatory Developments Affecting Molecular Testing
    Legal and Regulatory Developments Affecting Molecular Testing
    The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by...
    Speaker: Peter M Kazon, JD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
    14
     
     
  • MAY 28, 2014 | 10:30 AM
    Heavy/Light Chain Combination Assays: What Laboratories should know about M-Protein detection
    Heavy/Light Chain Combination Assays: What Laboratories should...
    Traditional testing methods for monoclonal protein in Plasma Cell Dyscrasias correctly identify a majority of patients. However, limitations in these methods can cause patients to be missed...
    Speaker: Richard O'Hara, PhD
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
    87
    MAY 28, 2014 | 6:00 AM
    How to Improve Healthcare with More Effective Clinical Laboratory Test Utilization
    How to Improve Healthcare with More Effective Clinical Laboratory...
    Due to the large increase in the number and complexity of clinical laboratory tests, optimal use of laboratory testing services has presented many challenges. The Clinical Laboratory Integrat...
    Speaker: Julie R Taylor, PhD, MS
    Presented at: Clinical Diagnostics & Research Virtual Event Series 2014
    184
    MAR 19, 2014 | 9:00 AM
    Remyelinating the adult central nervous system: Repairing injury in  MS
    Remyelinating the adult central nervous system: Repairing injury...
    Multiple Sclerosis is a debilitating neurodegnerative disease of the central nervous system in which the immune system targets and destroys myelin sheaths surrounding axons. Progressive a...
    Speaker: Ari Green, MD
    Presented at: Neuroscience Virtual Event Series 2014
    0
    MAR 19, 2014 | 7:00 AM
    Therapeutic Strategies for Cognitive Dysfunction in Down Syndrome
    Therapeutic Strategies for Cognitive Dysfunction in Down Syndrome
    Down syndrome (DS) is a complex multi-system disorder affecting more than 5.8 million individuals around the world and it causes significant physical, psychological, and cognitive abnormaliti...
    Speaker: Ahmad Salehi, MD, PhD
    Presented at: Neuroscience Virtual Event Series 2014
    15
    FEB 05, 2014 | 5:00 PM
    C.E. CREDITS
    Veterinary treatment approaches to common clinical signs in toxicology setting
    Veterinary treatment approaches to common clinical signs in toxicology...
    This presentation mainly includes 4 sections, the first one: introduction for CFDA/FDA GLP Regulation and analysis the difference. The second one: introduction of the most important responsi...
    Speaker: Xueying Pan, MS, PhD Candidate
    Presented at: Laboratory Animal Sciences Virtual Event Series 2014
    10
     
     
  • FEB 05, 2014 | 3:00 PM
    C.E. CREDITS
    Measuring Teaching - Metrics applied to training in lab animal sciences
    Measuring Teaching - Metrics applied to training in lab animal...
    The title of this presentation could have been Training within laboratory animal science - where we are and where we should be. While training has been the domain of facility managers for ma...
    Speaker: Bruce W Kennedy, MS RLATG CMAR CPIA
    Presented at: Laboratory Animal Sciences Virtual Event Series 2014
    28
    NOV 20, 2013 | 8:00 AM
    A comparison of genotyping platforms for pharmacogenetic testing
    A comparison of genotyping platforms for pharmacogenetic testing
    As the scientific evidence base for pharmacogenetics continues to expand, the use of such information in clinical management and drug development will be in demand. The FDA advises that the...
    Speaker: Mark Borgman, PhD
    Presented at: Advanced Genomics in Clinical and Translational Research - Fall
    210
    OCT 17, 2013 | 9:00 AM
    C.E. CREDITS
    Subtyping Circulating Tumor Cells in Breast Cancer for Personalized Therapeutics
    Subtyping Circulating Tumor Cells in Breast Cancer for Personalized...
    Cancer metastases develop when tumor cells known as circulating tumor cells (CTCs) are shed from a tumor, circulate through the blood stream and colonize a distant tissue. The number of CTCs...
    Speaker: Lori M. Millner, PhD
    Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2013
    86
    OCT 16, 2013 | 2:00 PM
    C.E. CREDITS
    PSA Screening and Early Detection for Prostate Cancer 2013: Controversy and Opportunity
    PSA Screening and Early Detection for Prostate Cancer 2013: Controversy...
    While the Prostate Specific Antigen (PSA) blood test has been available since 1986 and FDA-approved for the early detection of prostate cancer since the early 1990s, 2012 marked a critical in...
    Speaker: Judd W Moul, MD, FACS
    Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2013
    80
    OCT 16, 2013 | 10:00 AM
    C.E. CREDITS
    Keynote: Is Personalized (Molecularly-Based) Medicine our Best Hope to Finally Defeat Cancer?
    Keynote: Is Personalized (Molecularly-Based) Medicine our Best...
    The current paradigm of detecting established cancer (often too late) and treating routinely with cytotoxic drugs is beginning to change. Advanced technologies such as whole genome sequencin...
    Speaker: Anna Barker, PhD
    Presented at: Cancer: Research, Discovery and Therapeutics Virtual Event Series 2013
    37
     
     
  • AUG 22, 2013 | 3:00 PM
    C.E. CREDITS
    Evaluation challenges and regulatory considerations for next-generation sequencing and other high throughput genomic technology based clinical applications
    Evaluation challenges and regulatory considerations for next-generation...
    The use of ultrahigh throughput diagnostic tests that determine genetic sequence variation to guide patient care is rapidly expanding, fueled by the enormous growth in sequencing platform dev...
    Speaker: Živana Težak, PhD
    Presented at: Genetics and Genomics Virtual Event Series 2013
    282
    AUG 21, 2013 | 8:00 AM
    C.E. CREDITS
    Clinical Applications in Pharmacogenetics
    Clinical Applications in Pharmacogenetics
    As a component of individualized medicine, pharmacogenetics (PGx) focuses on how genetic factors influence individual responses to specific medications. The clinical goals of pharmacogenetics...
    Speaker: Linnea Baudhuin, PhD, DABMG
    Presented at: Genetics and Genomics Virtual Event Series 2013
    71
    MAY 30, 2013 | 8:00 AM
    VITROS® Microslide Technologies / Assays
    VITROS® Microslide Technologies / Assays
    VITROS® Microslides utilize a layered, dry-slide technology that enables separate reaction domains such that each step can be optimized to provide excellent assay performance. Excellent preci...
    Speaker: John Backus, PhD
    Presented at: Clinical Diagnostics Virtual Event Series 2013
    51
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