{"598527":{"#nid":"598527","#data":{"type":"event","title":"Investigational Device Exemption (IDE) Workshop","body":[{"value":"\u003Cp\u003E\u003Cstrong\u003EKelly Lindblom, Ph.D., R.A.C.\u003Cbr \/\u003E\r\nRegulatory Affairs Scientist\u003Cbr \/\u003E\r\nDuke University School of Medicine\u003C\/strong\u003E\u003Cbr \/\u003E\r\n\u003Cbr \/\u003E\r\nThis workshop will offer best practices when conducting trials using FDA approved and unapproved devices. It will give an overview of the marketing process for medical devices, the IDE application process, and the obligations of the sponsor-investigator once the IDE application is filed with the FDA. Case scenarios will be presented to enhance learning and stimulate audience participation.\u0026nbsp;\u003C\/p\u003E\r\n\r\n\u003Cp\u003EThis workshop will address the following questions (and more):\u003C\/p\u003E\r\n\r\n\u003Cul\u003E\r\n\t\u003Cli\u003EWhat is a medical device?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat is FDA\u0026rsquo;s approach to regulating the commercialization of medical devices?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat is the 510(k) pathway?\u003C\/li\u003E\r\n\t\u003Cli\u003EHow does FDA regulate mobile apps?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat are the benefits of a pre-submission meeting with the FDA?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat is an abbreviated IDE and when is this applicable?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat is the difference between an abbreviated IDE and a \u0026ldquo;full\u0026rdquo; IDE and when is the \u0026ldquo;full\u0026rdquo; IDE applicable?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat information needs to be included in an IDE?\u003C\/li\u003E\r\n\t\u003Cli\u003EHow do I submit my IDE application to the FDA?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat are the reporting requirements once my IDE is approved?\u003C\/li\u003E\r\n\u003C\/ul\u003E\r\n\r\n\u003Cp\u003EThis course is designed for anyone directly involved in conducting investigator-initiated trials:\u003C\/p\u003E\r\n\r\n\u003Cul\u003E\r\n\t\u003Cli\u003EInvestigators\u003C\/li\u003E\r\n\t\u003Cli\u003ERegulatory Personnel\u003C\/li\u003E\r\n\t\u003Cli\u003EClinical Research Nurses\u003C\/li\u003E\r\n\t\u003Cli\u003EClinical Research Associates\u003C\/li\u003E\r\n\u003C\/ul\u003E\r\n\r\n\u003Cp\u003EKelly Lindblom, Ph.D., is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Lindblom is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Lindblom is also involved in the implementation of educational initiatives within ORAQ.\u003C\/p\u003E\r\n\r\n\u003Cp\u003ELindblom received her undergraduate degree in chemistry from the University of North Carolina-Chapel Hill. She conducted her graduate research at Duke University, where she earned her PhD in Pharmacology with a certificate in Cell and Molecular Biology. Her research focused on the regulation of cell death in the context of Non-Alcoholic Steatohepatitis and different types of cancer. During her graduate training, Lindblom was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. Lindblom was the Assistant Director of Research Initiatives in the Office of the Vice Provost for Research at Duke University before joining ORAQ.\u003C\/p\u003E\r\n","summary":null,"format":"limited_html"}],"field_subtitle":"","field_summary":"","field_summary_sentence":[{"value":"Kelly Lindblom, Ph.D., R.A.C. - Duke University School of Medicine"}],"uid":"27195","created_gmt":"2017-11-08 12:58:33","changed_gmt":"2017-11-08 12:58:33","author":"Colly Mitchell","boilerplate_text":"","field_publication":"","field_article_url":"","field_event_time":{"event_time_start":"2018-01-24T11:00:00-05:00","event_time_end":"2018-01-24T13:00:00-05:00","event_time_end_last":"2018-01-24T13:00:00-05:00","gmt_time_start":"2018-01-24 16:00:00","gmt_time_end":"2018-01-24 18:00:00","gmt_time_end_last":"2018-01-24 18:00:00","rrule":null,"timezone":"America\/New_York"},"extras":[],"related_links":[{"url":"https:\/\/medschool.duke.edu\/research\/research-support-offices\/office-regulatory-affairs-and-quality\/meet-team\/regulatory-affairs-team","title":"Lindblom profile"}],"groups":[{"id":"1292","name":"Parker H. Petit Institute for Bioengineering and Bioscience (IBB)"},{"id":"1254","name":"Wallace H. Coulter Dept. of Biomedical Engineering"}],"categories":[],"keywords":[{"id":"248","name":"IBB"}],"core_research_areas":[],"news_room_topics":[],"event_categories":[{"id":"1789","name":"Conference\/Symposium"}],"invited_audience":[{"id":"78761","name":"Faculty\/Staff"},{"id":"78771","name":"Public"},{"id":"174045","name":"Graduate students"},{"id":"78751","name":"Undergraduate students"}],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cp\u003E\u003Ca href=\u0022mailto:hsolomon@gatech.edu\u0022\u003EHarold Solomon\u003C\/a\u003E\u003Cbr \/\u003E\r\nVentureLab, Principal\u003Cbr \/\u003E\r\nGeorgia Tech\u003C\/p\u003E\r\n","format":"limited_html"}],"email":[],"slides":[],"orientation":[],"userdata":""}}}