{"598526":{"#nid":"598526","#data":{"type":"event","title":"Investigational New Drug (IND) Workshop","body":[{"value":"\u003Cp\u003E\u003Cstrong\u003EKristen Foss, 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 drugs or substances (including biologics). It will give an overview of the IND application process and the regulatory obligations of the sponsor-investigator once an IND is filed with the FDA. Case scenarios will be presented to enhance learning and stimulate audience participation.\u003Cbr \/\u003E\r\n\u003Cbr \/\u003E\r\nThis workshop will address the following questions (and more):\u003C\/p\u003E\r\n\r\n\u003Cul\u003E\r\n\t\u003Cli\u003EWhat is an investigational drug?\u003C\/li\u003E\r\n\t\u003Cli\u003EDo I need an IND for my investigation? What are some examples of trials requiring an IND and examples of studies that are IND exempt?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhen do I need an IND for an investigation using dietary supplements?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhen should I consider having a Pre-IND meeting with the FDA?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat information needs to be included in my IND application?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat happens after I submit my IND application to the FDA?\u003C\/li\u003E\r\n\t\u003Cli\u003EWhat are the reporting requirements once my IND is effective?\u003C\/li\u003E\r\n\t\u003Cli\u003EHow and when should I report serious adverse events (SAEs) once I have an IND?\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\u003EKristen Foss, Ph.D., received her undergraduate degree in biology from South Dakota State University and then worked as a research associate at the Translational Genomics Research Institute in Phoenix, Arizona. Foss conducted her graduate research at Duke University, where she earned her Ph.D. in Pharmacology with a certificate in Cell and Molecular Biology. During her graduate training, Foss was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. She was also selected to participate in the Duke Scholars in Molecular Medicine Program in Oncology and Regenerative Medicine. Foss holds the US Regulatory Affairs Certification (R.A.C.) from the Regulatory Affairs Professional Society.\u003C\/p\u003E\r\n","summary":null,"format":"limited_html"}],"field_subtitle":"","field_summary":"","field_summary_sentence":[{"value":"Kristen Foss, Ph.D., R.A.C. - Duke University School of Medicine"}],"uid":"27195","created_gmt":"2017-11-08 12:47:28","changed_gmt":"2017-11-08 13:00:27","author":"Colly Mitchell","boilerplate_text":"","field_publication":"","field_article_url":"","field_event_time":{"event_time_start":"2018-01-23T11:00:00-05:00","event_time_end":"2018-01-23T13:00:00-05:00","event_time_end_last":"2018-01-23T13:00:00-05:00","gmt_time_start":"2018-01-23 16:00:00","gmt_time_end":"2018-01-23 18:00:00","gmt_time_end_last":"2018-01-23 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":"Foss 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\nPrincipal, VentureLab\u003C\/p\u003E\r\n","format":"limited_html"}],"email":[],"slides":[],"orientation":[],"userdata":""}}}