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    Regulatory Affairs

    Regulatory Affairs (RA) is a profession that ensures compliance within industries such as: pharmaceuticals, energy production, banking, and agrochemicals. RA works with government on all levels in order to monitor and advise on laws that coincide with a business. Such partnerships include: Food and Drug Administration, Securities and and Exchange Commission, and the Department of Energy.

    Webinars

    • JUN 08, 2016 | 11:00 AM
      Emerging infectious diseases - back to the future
      Emerging infectious diseases - back to the future
      An emerging infectious disease or re-emerging infectious disease is defined by WHO as “one that has appeared in a population for the first time, or that may have existed previously but...
      Speaker: Vickie Baselski, PhD, D(ABMM), F(AAM)
      Presented at: A Virtual Destination for Laboratory Professionals
      Sponsored By: Cardinal Health™ OptiFreight® Logistics, American Society for Clinical Laboratory Science (ASCLS)
      5
      APR 06, 2016 | 10:30 AM
      2016 and Beyond: Reimbursement and Regulatory Lessons for Another Year
      2016 and Beyond: Reimbursement and Regulatory Lessons for Another...
      This session will provide an update on PAMA, related coding initiatives, and what we are seeing from the payor perspective so far this year.  Participants will have a deeper understandin...
      Speaker: Rina Wolf, MHA
      Presented at: Molecular Diagnostics Virtual Event Series 2016
      4
      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
      SEP 30, 2015 | 1:30 PM
      Biomarkers: An Auspicious Beginning and a Portentous Future?
      Biomarkers: An Auspicious Beginning and a Portentous Future?
      Biomarkers, with their associated “tsunami” of publications, represent what is arguably one of the largest areas of scientific inquiry in the history of biomedicine. Touted as the...
      Speaker: Anna Barker, PhD
      Presented at: Cancer Research & Oncology Week Virtual Event Series 2015
      2
      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 Accurin™ 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
      SEP 03, 2015 | 6:00 AM
      Preservatives Now - Facts and Fictions
      Preservatives Now - Facts and Fictions
      Preservatives have been under attacks by NGO's and their willing accomplishes-the media and the marketers of cosmetics. But with all their science fiction and negative statements, what are t...
      Speaker: David Steinberg, FRAPS
      Presented at: Microbiology Virtual Event Series 2015
      2
      FEB 05, 2015 | 10:30 AM
      C.E. CREDITS
      Importance/effect of surgical training, skills and experience on performing surgical procedures within studies
      Importance/effect of surgical training, skills and experience...
      In the context of an experimental project requiring surgical preparation of animals, training is not only required for technicians lacking a strong surgical background but also for more exper...
      Speaker: Delphine Bouard DVM, Dip Vet LAS
      Presented at: Laboratory Animal Sciences Virtual Event Series 2015
      13
      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
      DEC 03, 2014 | 9:00 AM
      Leveraging new technologies in gluten related disorders:  Benefits before and after diagnosis
      Leveraging new technologies in gluten related disorders: Benefits...
       Contemporary serologic testing has revolutionized the field of celiac disease. Highly accurate serologic assays have shown the prevalence of celiac disease to be nearly 1:100 in many populat...
      Speaker: Daniel Leffler, MD, MS and Jack Maggiore, PhD
      Sponsored By: Inova Diagnostics, Inova Diagnostics
      21 1
      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
    JUN 08, 2016 | 11:00 AM
    Emerging infectious diseases - back to the future
    Emerging infectious diseases - back to the future
    An emerging infectious disease or re-emerging infectious disease is defined by WHO as “one that has appeared in a population for the first time, or that may have existed previously but...
    Speaker: Vickie Baselski, PhD, D(ABMM), F(AAM)
    Presented at: A Virtual Destination for Laboratory Professionals
    Sponsored By: Cardinal Health™ OptiFreight® Logistics, American Society for Clinical Laboratory Science (ASCLS)
    5
    APR 06, 2016 | 10:30 AM
    2016 and Beyond: Reimbursement and Regulatory Lessons for Another Year
    2016 and Beyond: Reimbursement and Regulatory Lessons for Another...
    This session will provide an update on PAMA, related coding initiatives, and what we are seeing from the payor perspective so far this year.  Participants will have a deeper understandin...
    Speaker: Rina Wolf, MHA
    Presented at: Molecular Diagnostics Virtual Event Series 2016
    4
    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
    SEP 30, 2015 | 1:30 PM
    Biomarkers: An Auspicious Beginning and a Portentous Future?
    Biomarkers: An Auspicious Beginning and a Portentous Future?
    Biomarkers, with their associated “tsunami” of publications, represent what is arguably one of the largest areas of scientific inquiry in the history of biomedicine. Touted as the...
    Speaker: Anna Barker, PhD
    Presented at: Cancer Research & Oncology Week Virtual Event Series 2015
    2
    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 Accurin™ 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
    SEP 03, 2015 | 6:00 AM
    Preservatives Now - Facts and Fictions
    Preservatives Now - Facts and Fictions
    Preservatives have been under attacks by NGO's and their willing accomplishes-the media and the marketers of cosmetics. But with all their science fiction and negative statements, what are t...
    Speaker: David Steinberg, FRAPS
    Presented at: Microbiology Virtual Event Series 2015
    2
    FEB 05, 2015 | 10:30 AM
    C.E. CREDITS
    Importance/effect of surgical training, skills and experience on performing surgical procedures within studies
    Importance/effect of surgical training, skills and experience...
    In the context of an experimental project requiring surgical preparation of animals, training is not only required for technicians lacking a strong surgical background but also for more exper...
    Speaker: Delphine Bouard DVM, Dip Vet LAS
    Presented at: Laboratory Animal Sciences Virtual Event Series 2015
    13
    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
    DEC 03, 2014 | 9:00 AM
    Leveraging new technologies in gluten related disorders:  Benefits before and after diagnosis
    Leveraging new technologies in gluten related disorders: Benefits...
     Contemporary serologic testing has revolutionized the field of celiac disease. Highly accurate serologic assays have shown the prevalence of celiac disease to be nearly 1:100 in many populat...
    Speaker: Daniel Leffler, MD, MS and Jack Maggiore, PhD
    Sponsored By: Inova Diagnostics, Inova Diagnostics
    21 1
     
     
  • 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
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