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Preconference Symposia - Monday, November 7, 2005 |
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7:00 a.m. |
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Congress Registration |
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8:30 a.m. |
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Preconference Symposia; Choose one only |
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Preconference I |
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Compliance Primer - How to Establish a Compliance Program for a Pharmaceutical Enterprise Robert A. Freeman US Compliance Officer and Compliance Counsel Serono, Inc. Rockland, MA Robert G. Homchick, Esq. Partner and Chair, Health Law Group Davis Wright Tremaine Seattle, WA Sheryl Vacca CHC, West Coast Life Science and Health Care Regulatory Practice Leader Deloitte & Touche LLP Immediate Past President, Health Care Compliance Association Costa Mesa, CA (Moderator) |
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Preconference II |
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Best Practices for Getting Cooperation for Risk Management and Corporate Compliance John T. Bentivoglio, Esq. Partner, King & Spalding Former Special Counsel for Healthcare Fraud Chief Privacy Officer, United States Department of Justice Washington, DC Ron Geigle President, Polidais Arlington, VA Charlie Lucas, Esq. Vice President, General Counsel Biotechnology Industry Association Washington, DC Nan Matthews President, The Matthews Group Littleton, CO Marie Marlow President, M Squared Associates, Inc. Formerly with Pfizer Hospital Products Group Washington, DC Steve Ojala, Ph.D. Global Director, Eli Lilly Indianapolis, IN Nancy Singer, Esq. President, Compliance-Alliance Former Special Counsel, AdvaMed Founder, AdvaMed Medical Technology Learning Institute Arlington, VA (Moderator) |
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Preconference III |
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Government Price Reporting - Staying Ahead of the Curve on Problems and Solutions Peter J. Claude Pharmaceutical and Life Sciences Advisory Services Partner, PricewaterhouseCoopers LLP Florham Park, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) Timothy Nugent Director, Pharmaceutical and Life Sciences Advisory Services PricewaterhouseCoopers LLP Florham Park, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) John D. Shakow, Esq. Counsel, King & Spalding LLP Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) David Weiss Solutions Architect Model N Clarendon Hills, IL Presentation Material (Acrobat) Presentation Material (Powerpoint) Jonathon L. Kellerman Director, Pharmaceutical and Medical Products Advisory Services PricewaterhouseCoopers LLP Philadelphia, PA (Moderator) |
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Noon |
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Adjournment |
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Pharma Congress Day One - Monday, November 7, 2005 |
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1:00 p.m. |
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Welcome and Introduction Bert Weinstein, Esq. Vice President, Corporate Compliance Purdue Pharma LP Stamford, CT (Co chair) Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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1:15 p.m. |
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OIG Oversight of the Pharmaceutical Industry Daniel R. Levinson Inspector General Department of Health and Human Services Washington, DC |
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1:45 p.m. |
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The New Medicare Prescription Drug Law - What's Next? Thomas Scully Senior Counsel, Alston & Bird Senior Adviser, Welsh, Carson, Anderson and Stowe Former Administrator, Centers for Medicare and Medicaid Services Department of Health & Human Services Washington, DC |
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2:15 p.m. |
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Compliance Lessons from the Trenches Alan Yuspeh, JD, MBA Senior Vice President, Ethics Compliance and Corporate Responsibility, HCA, Inc. Former Coordinator, Defense Industry Initiative on Business Ethics and Conduct Nashville, TN Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:45 p.m. |
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Compliance Perspectives from The Ethicist Randy Cohen Author, "The Ethicist" column The New York Times Magazine New York, NY |
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3:15 p.m. |
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Break |
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3:45 p.m. |
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Socratic Dialogue: The Top Five Pharmaceutical Compliance Issues in 2006 John T. Bentivoglio, Esq. Partner, King & Spalding Former Special Counsel for Healthcare Fraud Chief Privacy Officer, United States Department of Justice Washington, DC Lori Queisser Vice President and Chief Compliance Officer Eli Lilly and Company Indianapolis, IN Janet L. "Lucy" Rose, MBA President, Lucy Rose and Associates Former Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) Former Director, Office of Training and Communications Center for Drug Evaluation and Research (CDER) Food and Drug Administration Washington, DC Brian Salsberg, JD Associate Principal, Pharmaceutical and Medical Products Practice McKinsey & Company Florham Park, NJ Brenton L. Saunders, JD, MBA Senior Vice President, Global Compliance and Business Practices Schering-Plough Corporation Past President, Health Care Compliance Association Founder, International Association of Privacy Professionals Kenilworth, NJ Jonathan K. Sprole Vice President and Deputy General Counsel and Chief Compliance Officer Bristol-Myers Squibb Company New York, NY Arthur Miller, Esq. Bruce Bromley Professor of Law Harvard Law School Cambridge, MA (Moderator) |
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5:00 p.m. |
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Pharma Congress Interactive Hypothetical (click here for full details) This year the Pharma Congress will feature a complex hypothetical in which a pharmaceutical company is faced with a series of regulatory and compliance challenges. The hypothetical will be presented on Monday afternoon. On Tuesday part of concurrent session time will be dedicated to hypothetical resolution. The hypothetical will conclude on Wednesday morning. Throughout the Congress intervening events will create new challenges. Cast of Characters: Valli Baldassano Vice President, Global Compliance Commercial Operations, Schering-Plough Kenilworth, NJ William T. Fitzgerald Director, Global Compliance Alcon Laboratories Fort Worth, TX Linda Heitzman Director, Life Sciences & Healthcare Deloitte & Touche LLP Cincinnati, OH Lori Queisser Vice President and Chief Compliance Officer Eli Lilly and Company Indianapolis, IN Arjun Rajaratnam, JD Vice President and Compliance Officer Global Pharmaceuticals, GlaxoSmithKline Research Triangle Park, NC Brian Riewerts Senior Manager, Global Pharmaceutical Advisory Services Group PricewaterhouseCoopers LLP Baltimore, MD Sue Seferian, Esq. Senior Counsel Corporate Law Department Johnson & Johnson New Brunswick, NJ Michael Shaw Deputy Compliance Officer Novartis Pharmaceuticals Corporation East Hanover, NJ James Sheehan, Esq. Associate United States Attorney U.S. Attorney's Office for the Eastern District of Pennsylvania Philadelphia, PA Eric Siegel Vice President, Associate General Counsel & Chief Compliance Officer Cephalon, Inc. Frazer, PA Paul J. Silver National Leader, Health Sciences Investigative and Dispute Services Ernst & Young LLP Atlanta, GA Kelly M. Talley Director Global Medical Affairs Compliance Bristol-Myers Squibb Company New York, NY Bert Weinstein, Esq. Vice President, Corporate Compliance Purdue Pharma LP Stamford, CT Keith M. Korenchuk, JD, MPH Partner, McGuire Woods Charlotte, NC (Co chair) |
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6:30 p.m. |
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Adjournment and Code of Conduct Poster Board and Exchange Reception The Pharma Congress Monday Networking Reception will feature the exchange and presentation of company Codes of Conduct at poster boards throughout the Pharma Congress Exhibi Hall. Participating Companies to Date:
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