{"id":13795,"date":"2004-09-20T00:00:00","date_gmt":"2004-09-20T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/uncategorized\/m006cmtg077\/"},"modified":"2019-03-01T15:05:31","modified_gmt":"2019-03-01T15:05:31","slug":"m006cmtg077","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/meetings\/m006cmtg077\/","title":{"rendered":"The 3rd Annual Off-Label Usage Conference"},"content":{"rendered":"<p>  <b>Featured Conference<\/b> <\/p>\n<p>     <b><a href=\"http:\/\/www.pharmedassociates.com\/regulatory.asp#p182\">The 3rd Annual Off-Label Usage Conference<\/a><\/b><br \/>  <i>How to Increase Revenues, Comply with Regulations, and Avoid Penalties<\/i><br \/> September 20-21, 2004 \u0095 Philadelphia, PA   <\/p>\n<p> <b>Visit the <a href=\"http:\/\/www.pharmedassociates.com\/regulatory.asp#p182\">conference website<\/a> for more information and to register.<\/b> <\/p>\n<\/p>\n<p> Off-label usage of drugs and medical devices accounts for a large percentage of profits yet also presents a minefield of potential legal, regulatory, ethical, and financial problems. To make matters worse, the regulatory and legal landscape has become more varied and confusing in recent years as organizations such as the DOJ, the OIG, and more have become involved. Here\u0092s a chance for you to <b>learn everything you need to know<\/b> about this difficult topic in one easy stop.   <\/p>\n<p><b>This conference addresses the following issues (and more):<\/b>  <\/p>\n<ul>\n<li>Understanding and complying with the FDA on off-label issues <\/li>\n<li>Knowing who regulates off-label issues other than the FDA\u0097and what you need to comply with <\/li>\n<li>Using your First Amendment Rights to communicate valuable information <\/li>\n<li>Proactive steps to take to minimize your off-label risks and avoid costly penalties <\/li>\n<li>Transforming off-label data into valuable on-label information <\/li>\n<li>Training your sales force on off-label issues: What to do, and what not to do <\/li>\n<li>Maximizing your Medicare and Medicaid reimbursements while avoid penalties <\/li>\n<\/ul>\n<p><b>Be sure to attend one of the two pre-conference workshops:<\/b><\/p>\n<p>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0  <b>Workshop 1: Effective Interactions between Pharmaceutical Manufacturers and Healthcare Professionals: Minimizing Your Company\u0092s Regulatory and Liability Risks<\/b>  \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0  \u00a0\u00a0\u00a0\u00a0  Reviews of previous off-label workshops led by Alan Minsk for Pharmaceutical Education Associates:<\/p>\n<p><i>&#8220;Very animated and dynamic speaker&#8230;very informative, knew subject matter extremely well.&#8221;<\/i> Angela Sidoti, Imovex <\/p>\n<p><i>&#8220;Topic and content was relevant and met the audience needs. He is a greater presenter.&#8221;<\/i> Jerri Anne Johnson, Abbott Labs <\/p>\n<p><i>&#8220;Alan is a very energetic speaker and the topic was timely. Audience was fully engaged for entire workshop.&#8221;<\/i> Nancy Coddington, AstraZeneca <\/p>\n<p><i>&#8220;Added humor to OIG\/PhRMA content. Kept it real and comprehensive.&#8221;<\/i> Jackie Ruka, DiMedix <\/p>\n<p>  \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0  <b>Workshop 2 (NEW WORKSHOP ADDED FOR UNIQUE ISSUES OF MEDICAL DEVICE COMMUNITY): Off-Label and Medical Devices: Unique Aspects, Issues, and Concerns for the Medical Device Community<\/b>  <\/p>\n<p><b>Plus learn from these special features<\/b>  <\/p>\n<ul>\n<li>In-depth three-part presentation on CME issues related to off-label usage <\/li>\n<li>Comprehensive two-part discussion from plaintiff lawyers: hear a unique perspective and learn from the mistakes of other! <\/li>\n<\/ul>\n<p><b>Hear from the collected experience of our well-regarded, diverse faculty: <\/b> <\/p>\n<p><b>Joel M. Androphy,<\/b> Attorney, Berg &amp; Androphy<br \/><b>Peggy J. Berry,<\/b> Director, Promotional Regulatory Affairs, AstraZeneca<br \/><b>Barbara R. Binis,<\/b> Partner, Product Liability, Reed Smith, LLP<br \/><b>Thomas Blok,<\/b> Medical Director, Medical Affairs, Pfizer<br \/><b>Paul Kaufman,<\/b> Civil Health Care Fraud Coordinator, U.S. Attorney\u0092s Office, E.D.N.Y.<br \/><b>Daniel A. Kracov,<\/b> Partner, Patton Boggs, LLP<br \/><b>Erika Kelton,<\/b> Partner, Phillips &amp; Cohen, LLP<br \/><b>Robert J. Klepinski,<\/b> Managing Partner and President, Klepinski &amp; Duval, PA<br \/><b>Leonard Lescosky,<\/b> Director of Regulatory Affairs, Solvay Pharmaceuticals<br \/><b>Michael Loucks,<\/b> Assistant US Attorney, Department of Justice (invited)<br \/><b>Mark McAndrew,<\/b> Wiley, Rein, &amp; Fielding, LLP<br \/><b>William A. McGrath,<\/b> Partner, Wiley, Rein, &amp; Fielding LLP<br \/><b>Alan G. Minsk,<\/b> Partner and Leader, Food and Drug Practice Team, Arnall Golden Gregory, LLP<br \/><b>Viveca Parker,<\/b> Assistant US Attorney, Eastern District of Pennsylvania, Department of Justice<br \/><b>Harold Pellerite,<\/b> Center for Devices and Radiological Health, FDA (invited)<br \/><b>Judith Ribble,<\/b> Director, Continuing Medical Education, Medscape<br \/><b>Mark H. Schaffer,<\/b> Vice President, Continuing Medical Education, Thomson Professional Postgraduate Services<br \/><b>Elaine Tompary,<\/b> Regional Manager Medical Science Liaison, McNeil Consumer and Specialty Pharmaceutical<br \/>  <b>Visit the <a href=\"http:\/\/www.pharmedassociates.com\/regulatory.asp#p182\">conference website<\/a> for more information and to register.<\/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>\n","protected":false},"excerpt":{"rendered":"<p>Off-label usage of drugs and medical devices accounts for a large percentage of profits yet also presents a minefield of potential legal, regulatory, ethical, and financial problems. To make matters worse, the regulatory and legal landscape has become more varied and confusing in recent years as organizations such as the DOJ, the OIG, and more have become involved. Here\u0092s a chance for you to learn everything you need to know about this difficult topic in one easy stop.<\/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>The 3rd Annual Off-Label Usage Conference - 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\/m006cmtg077\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The 3rd Annual Off-Label Usage Conference - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Off-label usage of drugs and medical devices accounts for a large percentage of profits yet also presents a minefield of potential legal, regulatory, ethical, and financial problems. 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