School of Medicine Events http://www.med.unc.edu/www daily 1 2010-08-04T22:25:27Z Investigational Device Exemption (IDE) Workshop http://www.med.unc.edu/www/events/investigational-device-exemption-ide-workshop-1 This course will offer best practices when conducting trials using FDA approved and non-approved devices. It will cover the IDE application process and the obligations of the sponsor-investigator once the IDE application is filed with the FDA. This workshop will address the following information:

  • Definition of a medical device
  • Examples of when an IDE is required by the FDA
  • What are PMA, 510k, and other terms used in device regulations?
  • What is an abbreviated IDE and when is this applicable?
  • What is the difference between an abbreviated IDE and a “full” IDE and when is the “full” IDE applicable?
  • How do I submit my IDE application to the FDA?
  • How do I maintain the IDE once it’s filed with the FDA?
  • How and when should I report Serious Adverse Events (SAEs) once I hold the IDE?
  • Is my trial required to be registered on Clinicaltrials.gov?
  • Roundtable discussion about the IDE process and general questions from participants

    •  

    This course designed for anyone directly involved in conducting investigator-initiated trials:

  • Investigators
  • Regulatory Personnel
  • Clinical Research Nurses
  • Clinical Research Associates

    • To register, please visit http://tinyurl.com/cmckye6


    Investigational New Drug (IND) and Investigational Device Exemption (IDE) Workshops
    These workshops are a CTSA collaboration by the NC TraCS (Translational and Clinical Sciences) Institute and the Duke Translational Medical Institute (DTMI).

    The IND and IDE Workshops have each been pre-approved for 3 Contact Hours of Clinical Research Education for re-certification of ACRP’s CCRC®, CCRA®, CPI®, at no cost. Certificates of attendance will be available at the conclusion of the training. For nurses or others in need of Continuing Education Units, 3 CEUs are available at a cost of $6 per day (please provide payment in the form of a check and your PID number on the day of training).

    ]]>     No publisher Beatrice Moss 2013-04-08T15:24:32Z Event     Pathology & Lab Medicine Grand Rounds, Alan S. Fanning, PhD http://www.med.unc.edu/www/events/pathology-lab-medicine-grand-rounds-alan-s-fanning-phd "New Roles for the Tight Junction Scaffolds ZO-1 and -2 in Epithelial Barrier Formation” Thursday, May 23, 2013, 8:30 AM, G100 Bondurant Hall

     

    "New Roles for the Tight Junction Scaffolds ZO-1 and -2 in

    Epithelial Barrier Formation”

     

    Alan S. Fanning, PhD

    Research Associate Professor, Department of Cell Biology and Physiology

    The University of North Carolina at Chapel Hill

    ]]>     No publisher Brenda W Brock 2013-05-07T20:19:30Z Event     High Resolution Label-Free In Vivo Molecular Imaging http://www.med.unc.edu/www/events/high-resolution-label-free-in-vivo-molecular-imaging BRIC Seminar Series Presented by Stephen Wong, Ph.D. Systems Medicine and Bioengineering Department, The Methodist Hospital Research Institute Houston, TX The clinical deployment of in vivo molecular imaging faces two major hurdles.  First, most in vivo molecular imaging techniques require the injection of exogenous contrast agents or labels into human body to aid detection, diagnosis, or targeted therapy.  The development of such imaging agents, however, is treated similar to the development of drugs by FDA and thus subjects to the lengthy and expensive process of FDA approval, yet contrast agents have much smaller market as drugs.  Second, the relatively low spatial resolution of current imaging modalities prevents them from detecting and visualizing molecular signatures and physiopathology changes at the cellular level in vivo for more precise and earlier intervention. In this talk, we present an alternate paradigm of in vivo molecular imaging based on the principle of label-free molecular vibrational imaging, in particular, coherent anti-Stokes Raman scattering (CARS) or Stimulated Raman Scattering (SRS), in order to sidestep the two hurdles.  We will discuss certain ongoing applications in our laboratory, such as image-guided intervention of peripheral lung cancer, nerve sparing robotic prostatectomy, tumor margin detection during lumpectomy, and neurovascular micro-ablation to illustrate the potential and practicality of this new class of label-free imaging devices.

    ]]>     No publisher Laurie B. Birdsong 2013-05-21T14:51:48Z Event     Hettleman Lectures http://www.med.unc.edu/www/events/hettleman-lectures Distinguished young scholars and winners of the Phillip and Ruth Hettleman Prize for Artistic and Scholarly Achievement, Dr. Kimryn Rathmell and Dr. Evan Dellon will be presenting.

    The University of North Carolina at Chapel Hill and Chancellor Holden Thorp invite you to attend lectures by two of our most distinguished young scholars and winners of the Phillip and Ruth Hettleman Prize for Artistic and Scholarly Achievement.

    Dr. Kimryn Rathmell, Associate Professor, Departments of Medicine and Genetics will be presenting her talk "Translational Studies in Renal Cell Carcinoma" at 1:15pm.

    Dr. Evan Dellon, Assistant Professor, Department of Medicine will be presenting his talk "Eosinophilic Esophagitis: Anatomy of a New Disease" at 2:15pm.

    ]]>     No publisher Bridget Riordan 2013-05-14T20:29:38Z Event     Pathology & Lab Medicine Grand Rounds, Mehmet Kesimer, PhD http://www.med.unc.edu/www/events/pathology-lab-medicine-grand-rounds-mehmet-kesimer-phd “Dissecting the role of mucins in airway mucosal protection and pathogenesis” Thursday, May 30, 2013, 8:30 AM, G100 Bondurant Hall

    “Dissecting the role of mucins in airway mucosal protection

    and pathogenesis”

    Mehmet Kesimer, PhD

    Associate Professor, Pathology and Laboratory Medicine

    The University of North Carolina at Chapel Hill

    ]]>     No publisher Brenda W Brock 2013-05-07T20:21:49Z Event     School of Medicine Web System: Introduction & Training http://www.med.unc.edu/www/events/cmsintro-copy2 Get started building your site with the new School of Medicine Web System. Register Now!

    Ready to start building your site in the new School of Medicine Web System?  Have you been wanting a refresher course on how to add pages to your existing site?  Then this is the class for you.  This hands-on class will go over the basics of building your site, from structure and layout to adding files and images.  If you're not familiar with the new School of Medicine Web System, check out our online Web Guide.

    Classes are held in 67 MacNider Hall, site of the Faculty Multimedia Development Lab, and last about an hour. Space is limited, so reserve your seat by registering in advance. If you are unable to attend, please email webhelp@med.unc.edu to cancel your reservation.

    ]]>     No publisher David W Kinton Class 2008-07-07T17:15:00Z Event     Title of Talk TBA http://www.med.unc.edu/www/events/title-of-talk-tba-5 Walter Kahr, MD, PhD University of Toronto ]]> No publisher Kimberly C Bodis 2013-02-07T18:54:45Z Event Using platelet physiology to assess big and small RNA function http://www.med.unc.edu/www/events/title-of-talk-tba-6 Paul Bray, MD Thomas Jefferson University ]]> No publisher Kimberly C Bodis 2013-02-07T18:54:47Z Event School of Medicine Web System: Introduction & Training http://www.med.unc.edu/www/events/cmstraining1-copy2 Get started building your site with the new School of Medicine Web System. Register Now!

    Ready to start building your site in the new School of Medicine Web System?  Have you been wanting a refresher course on how to add pages to your existing site?  Then this is the class for you.  This hands-on class will go over the basics of building your site, from structure and layout to adding files and images.  If you're not familiar with the new School of Medicine Web System, check out our online Web Guide.

    Classes are held in 67 MacNider Hall, site of the Faculty Multimedia Development Lab, and last about an hour. Space is limited, so reserve your seat by registering in advance. If you are unable to attend, please email webhelp@med.unc.edu to cancel your reservation.

    ]]>     No publisher David W Kinton Class 2013-05-07T18:49:40Z Event     Title of Talk TBA http://www.med.unc.edu/www/events/title-of-talk-tba-7 Bruce Sullenger, PhD Duke University ]]> No publisher Kimberly C Bodis 2013-02-07T18:54:49Z Event CRMS Training 2.0 http://www.med.unc.edu/www/events/crms-training-2.0 Review the basic features of UNC's CRMS. The CTRC will be launching a completely new online scheduler very soon. The new scheduler will be integrated into UNC’s Clinical Research Management System (CRMS.) In order to utilize the new scheduler you will need to be familiar with all of the new scheduler capabilities.

    Beginning later this spring, a second CRMS training session will be available featuring our new re-design to make accessing information easier and to make research subject visit tracking and CTRC visit scheduling available. To use these new features, it is important that you have been trained to use the basic CRMS features. If you have not already attended this training session, or need a refresher, we will be show you how to:

    • Use the CRMS home page to keep track of IRB and CRMS records 
    • Enter a study into CRMS and link it to IRB Records 
    • Update the research team and track team activities 
    • Enter study cohorts, procedures and visits and pull them into a schedule of events 
    • Use the new research fee schedule 
    • Complete a budget 
    • Enter your sponsor’s budget offer into CRMS and test it against your internal budget 
    • Do rough forecasting of subject enrollment

    We’ll also cover the steps for doing online submissions to OCT, IDS and Patient Accounts. Feel free to bring your laptop for extra ‘hands-on’ training.

    ]]>     No publisher Beatrice Moss 2013-05-17T18:31:01Z Event     Title of Talk TBA http://www.med.unc.edu/www/events/title-of-talk-tba-8 Keith McCrae, MD Cleveland Clinic ]]> No publisher Kimberly C Bodis 2013-02-07T18:54:51Z Event The UNC Lineberger Blue Ribbon Gala http://www.med.unc.edu/www/events/the-unc-lineberger-blue-ribbon-gala Unlock the mysteries of cancer and celebrate those who have made extraordinary contributions in cancer research, treatment and advocacy at a Gala reception and dinner benefitting UNC Lineberger Comprehensive Cancer Center. ]]> No publisher Lauren Beaumont 2013-02-20T17:38:30Z Event Title of Talk TBA http://www.med.unc.edu/www/events/title-of-talk-tba-9 Evan Sadler, MD, PhD Washington University in St. Louis ]]> No publisher Kimberly C Bodis 2013-02-07T18:54:53Z Event 7th Symposium on Hemostasis: http://www.med.unc.edu/www/events/7th-symposium-on-hemostasis More information to follow~ ]]> No publisher Christine Hill 2013-05-10T12:50:36Z Event