{"id":13783,"date":"2004-02-26T00:00:00","date_gmt":"2004-02-26T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/uncategorized\/m006-mtg050\/"},"modified":"2019-03-01T15:05:22","modified_gmt":"2019-03-01T15:05:22","slug":"m006-mtg050","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/meetings\/m006-mtg050\/","title":{"rendered":"Navigating the Risks of Off-label Usage"},"content":{"rendered":"<p>  <b>Featured Conference<\/b> <\/p>\n<p>      <b><a href=\"http:\/\/www.pharmedassociates.com\/marketing.asp#p153\">Navigating the Risks of Off-label Usage<\/a><\/b><br \/>  <i>To Avert the Legal, Regulatory, Marketing and Medical Implications<\/i><br \/> February 26-27, 2004 \u0095 Washington, DC <\/p>\n<p> <b><a href=\"http:\/\/www.pharmedassociates.com\/marketing.asp#p153\">Visit the conference site<\/a><\/b> <\/p>\n<\/p>\n<p> <b>The postmarket development of pharmaceuticals is vital to the success of many brands;<\/b> however manufacturers must wrestle with an assortment of issues that ensue. Success, which is often hinged on off-label usage, may sway profits, but also raises many legal, regulatory, financial and health hazards. <b>Risk preventative measures can be implemented to avoid the hazards that are particular to off-label usage.<\/b> The <b>Navigating the Risks of Off-Label Usage<\/b> conference addresses how to recognize and avoid behavior that can land your company in legal and financial hot water.  <\/p>\n<p>  Following up on our highly acclaimed Fall event, <b>Pharmaceutical Education Associates<\/b> is proud to present the Navigating the Risks of Off-Label Usage Spring 2004 conference, taking place February 26-27, 2004 in Washington, DC.  <\/p>\n<p> This exclusive event addresses critical issues including: <\/p>\n<ul>\n<li>FDA Policies Regarding Off-Label Activity <\/li>\n<li>Recent Enforcement of FDA Off-Label Regulations <\/li>\n<li>Identifying False Claims and Safe Harbors <\/li>\n<li>Essential Postmarket Risk Preventing Measures <\/li>\n<li>Court Ruling on First Amendment Rights <\/li>\n<li>Legal Implications Beyond the FDA Regulations <\/li>\n<li>Assessment of Health Outcomes for Off-Label Usage <\/li>\n<li>&#8230;and much more! <\/li>\n<\/ul>\n<hr\/>\n<p><b>Don&#8217;t Miss the Pre-Conference Workshop<\/b> <\/p>\n<hr\/>\n<p><b>Managing Interactions between Pharmaceutical Manufacturers <br \/> and Healthcare Professionals<\/b>  <i>Facilitated by<\/i> <b>Alan G. Minsk,<\/b> <i>Partner,<\/i> ARNALL, GOLDEN GREGORY, LLP <\/p>\n<hr\/>\n<p><b>Industry Experts Participating Include:<\/b> <\/p>\n<hr\/>\n<p><b>Barbara R. Binis<\/b><br \/><i>Partner<\/i><br \/> REED SMITH, LLP<br \/><b>Thomas M. Conroy<\/b><br \/><i>Senior Regulatory Affairs<\/i><br \/> ABBOTT LABORATORIES INC<br \/><b>Jianefi Guo<\/b><br \/><i>Co-Principal Investigator<\/i><br \/> OHIO MEDICAID DRUG UTILIZATION REVIEW<br \/><b>John Kamp<\/b><br \/><i>Of Counsel<\/i><br \/> WILEY REIN &amp; FIELDING, LLP<br \/><b>Daniel A. Kracov<\/b><br \/><i>Partner<\/i><br \/> PATTON BOGGS, LLP<br \/><b>Arthur Levine<\/b><br \/><i>Partner<\/i><br \/> ARNOLD &amp; PORTER<br \/><b>Geoffrey Levitt<\/b><br \/><i>Vice President &amp; Chief Regulatory Counsel<\/i><br \/> WYETH PHARMACEUTICALS<br \/><b>William McGrath<\/b><br \/><i>Partner<\/i><br \/> WILEY REIN &amp; FIELDING, LLP<br \/><b>Alan G. Minsk<\/b><br \/><i>Partner &amp; Leader, Food and Drug Law<\/i><br \/> ARNALL GOLDEN GREGORY, LLP  <\/p>\n<hr\/>\n<p><b>Praise for the previous Navigating the Risks of Off-Label Usage conference:<\/b> <\/p>\n<hr\/>\n<p><i>&#8220;One of the best meetings I have attended! Structure, content, speaker quality, staff.&#8221;<\/i> MD, Clinical Development, Diagnostics, BERLEX LABORATORIES \u00a0 <i>&#8220;I found the conference topics to be very informative and enlightening about where FDA and Industry stand on off-label.&#8221;<\/i> Regulatory Affairs Associate, NABI BIOPHARMACEUTICALS \u00a0 <i>&#8220;The program was well thought out and was organized in a logical progression.&#8221;<\/i> Associate Director, Medical Information, FUJISAWA HEALTHCARE  <\/p>\n<p> For more information about registering for this conference, <b><a href=\"http:\/\/www.pharmedassociates.com\/marketing.asp#p153\">visit the conference site<\/a><\/b>. <\/p>\n<p>  <a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/pm-mtgs.html\"><i>Return to list of conferences&#8230;<\/i><\/a> <\/p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The postmarket development of pharmaceuticals is vital to the success of many brands; however manufacturers must wrestle with an assortment of issues that ensue. Success, which is often hinged on off-label usage, may sway profits, but also raises many legal, regulatory, financial and health hazards. Risk preventative measures can be implemented to avoid the hazards that are particular to off-label usage. The Navigating the Risks of Off-Label Usage conference addresses how to recognize and avoid behavior that can land your company in legal and financial hot water.<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1203],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Navigating the Risks of Off-label Usage - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/meetings\/m006-mtg050\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Navigating the Risks of Off-label Usage - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"The postmarket development of pharmaceuticals is vital to the success of many brands; however manufacturers must wrestle with an assortment of issues that ensue. 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