Transcription of Pharmaceutical Compliance Program Elements
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Pharmaceutical Compliance Program Elements
Pharmaceutical Compliance Program ElementsPharmaceutical Compliance ForumSeptember 15, 2009 Bridgewater, NJJohn T. BentivoglioSkadden, ArpsMatthew D AmbrosioProstrakan, of Discussion Sentencing Guidelines HHS OIG Guidance DOJ Guidance on Compliance programs Advanced Pharma Compliance Issues DiscussionA Brief History of Corporate federal Sentencing Guidelines1996 CaremarkDecision2001 Enron Collapse &TAP Settlement2002 PhRMACode&SOX2004 Amended SentencingGuidelines1997 OIGM odel ComplianceGuidelines(Clinical Labs)2003 OIGP harmaGuidelines&DOJ sThompsonMemoCompliance Time Line2005 Corporate Sentencing Guidelines provide reduction in fines for effective Compliance programs . Seven Elements a cause of action against board members for failing to take minimal steps to achieve legal Compliance now known as a Caremark Claim .Guidelines for US Attorneys in charging on real v.
A Brief History of Corporate Compliance 1991 U.S. Federal Sentencing Guidelines 1996 Caremark Decision 2001 Enron Collapse & TAP Settlement 2002 PhRMA Code
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