{"117211":{"#nid":"117211","#data":{"type":"event","title":"TRIBES presents - An In-Depth Panel Discussion: Negotiating with the FDA","body":[{"value":"\u003Cp\u003EOne of the most critical and potentially frustrating components of dealing with the FDA is not following the statutes and regulations, but the process of negotiation with FDA officials.\u0026nbsp; To resolve disputes with the agency, companies must come to an agreement with the FDA to which they can actually adhere in the future. Often, a dispute calls for high-stakes negotiations in the face of possible individual liability under the Park Doctrine or potentially huge fines resulting from multiple instances of off-label promotion, among other risks. Is your company prepared to handle such a situation?\u0026nbsp;\u0026nbsp;\u003Cbr \/\u003E\u003Cbr \/\u003EJoin us for this Free interactive panel with some of the industry\u2019s top experts to help guide you through the complicated process of negotiating with the FDA to resolve enforcement and compliance disputes.\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Cstrong\u003ELearning Points:\u003C\/strong\u003E\u003C\/p\u003E\u003Cul\u003E\u003Cli\u003EDiscuss negotiating enforcement and compliance with government officials dealing with: Injunction actions and consent decrees, GMPs, plea agreements, off-label promotion and\u0026nbsp;\u0026nbsp;warning letters\u003C\/li\u003E\u003Cli\u003EUnderstand the extent of your ability to negotiate with the FDA and other government agencies\u003C\/li\u003E\u003C\/ul\u003E\u003Cp\u003E\u003Cstrong\u003E\u0026nbsp;\u003C\/strong\u003E \u003Cstrong\u003EMeet Your Panel\u003C\/strong\u003E\u003Cstrong\u003E:\u003C\/strong\u003E\u003Cstrong\u003E\u003Cbr \/\u003E\u003Cstrong\u003EModerator: Arthur N. Levine\u003C\/strong\u003E\u003C\/strong\u003E\u0026nbsp;is a retired partner of the Washington, D.C., law firm of Arnold \u0026amp; Porter L.L.P., where he counseled pharmaceutical and medical device companies on a wide variety of compliance and regulatory issues.\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EMr. Michael Hinckle\u003C\/strong\u003E\u0026nbsp;is a partner with K\u0026amp;L Gates.\u0026nbsp; His practice focuses on counseling corporations and individuals on all aspects of FDA regulatory and corporate matters\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EMr. Mailhot\u003C\/strong\u003E\u0026nbsp;is a special counsel in the Washington D.C. office, and is a member of the firm\u0027s Food and Drug Law Group, as well as the firm\u0027s Life Sciences group. Mr. Mailhot\u0027s 14 years working in the U.S. Food and Drug Administration (FDA) provides a unique perspective in his counseling of clients on a broad range of matters involving the FDA.\u003C\/p\u003E","summary":null,"format":"limited_html"}],"field_subtitle":"","field_summary":[{"value":"\u003Cp\u003EOne of the most critical and potentially frustrating components of dealing with the FDA is not following the statutes and regulations, but the process of negotiation with FDA officials.\u0026nbsp; To resolve disputes with the agency, companies must come to an agreement with the FDA to which they can actually adhere in the future. Often, a dispute calls for high-stakes negotiations in the face of possible individual liability under the Park Doctrine or potentially huge fines resulting from multiple instances of off-label promotion, among other risks. Is your company prepared to handle such a situation?\u0026nbsp;\u0026nbsp;\u003Cbr \/\u003E\u003Cbr \/\u003E\u003C\/p\u003E","format":"limited_html"}],"field_summary_sentence":[{"value":"Join us for this free interactive panel with some of the industry\u2019s top experts."}],"uid":"27349","created_gmt":"2012-03-16 08:51:59","changed_gmt":"2016-10-08 01:58:25","author":"Floyd Wood","boilerplate_text":"","field_publication":"","field_article_url":"","field_event_time":{"event_time_start":"2012-03-28T19:00:00-04:00","event_time_end":"2012-03-28T20:30:00-04:00","event_time_end_last":"2012-03-28T20:30:00-04:00","gmt_time_start":"2012-03-28 23:00:00","gmt_time_end":"2012-03-29 00:30:00","gmt_time_end_last":"2012-03-29 00:30:00","rrule":null,"timezone":"America\/New_York"},"extras":[],"groups":[{"id":"1292","name":"Parker H. Petit Institute for Bioengineering and Bioscience (IBB)"}],"categories":[],"keywords":[{"id":"9548","name":"Barbara Boyan"},{"id":"248","name":"IBB"},{"id":"12418","name":"TRIBES"}],"core_research_areas":[],"news_room_topics":[],"event_categories":[],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cp\u003E\u003Ca href=\u0022mailto:maribel.baker@bme.gatech.edu\u0022\u003EMaribel Baker\u003C\/a\u003E\u003C\/p\u003E","format":"limited_html"}],"email":[],"slides":[],"orientation":[],"userdata":""}}}