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PRE-CONFERENCE SYMPOSIUM Wednesday, June 6, 2007 |
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7:00 a.m. |
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Congress Registration |
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8:00 a.m. |
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PRECONFERENCE I |
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An Overview of the United States Regulatory Environment (FDA and Healthcare) for International Pharmaceutical Compliance Professionals Paul E. Kalb, JD, MD Partner and Chair, National Health Care Group Sidley Austin LLP Washington, DC, USA Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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8:30 a.m. |
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Key Enforcement Issues: The Government's Perspective Kathleen Meriwether, Esq. Assistant United States Attorney Eastern District of Pennsylvania Department of Justice Philadelphia, PA USA Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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9:00 a.m. ![]() ![]() ![]() ![]() |
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Panel Discussion of Key Compliance Considerations and Strategies Stephen J. Immelt, Esq. Partner, Hogan & Hartson Former Assistant US Attorney, District of Maryland Baltimore, MD, USA Presentation Material (Acrobat) Presentation Material (Powerpoint) Jonathon L. Kellerman Partner - Advisory Health Industries Pharmaceutical and Medical Device Sector PricewaterhouseCoopers LLP Philadelphia, PA No presentation provided Arjun Rajaratnam, Esq. Compliance Officer, Global Pharmaceuticals GlaxoSmithKline Research Triangle Park, NC, USA No Presentation Provided Paul E. Kalb, JD, MD Partner and Chair, National Health Care Group Sidley Austin LLP Washington, DC, USA (Moderator) |
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10:00 a.m. |
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Preconference Adjournment |
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8:00 a.m. |
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PRECONFERENCE II |
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Advanced Issues in FCPA Compliance: Overview of Elements and Definitions, Applicability to Entities and Individuals, Jurisdiction and Agencies Involved, Penalties Gordon Chapman Senior Director Compliance Bristol-Myers Squibb New York, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) Ted Acosta, Esq. Principal, Ernst & Young LLP New York, NY, USA (Moderator) |
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9:00 a.m. ![]() |
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Enforcement, Dealing with Inquiries and Investigations, Preventive Measures, Compliance Programs, Continuous Monitoring and Auditing Bruce E. Yannett, Esq. Partner, Debevoise & Plimpton LLP New York, NY, USA Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:00 a.m. |
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Preconference Adjournment |
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International Pharma Congress Day One Wednesday, June 6, 2007 |
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10:30 a.m. ![]() ![]() |
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Welcome and Overview of Day I Themes: Environment, Image and Emerging Issues Sue Egan Compliance Officer, Pharma Europe GlaxoSmithKline London, UK (Co chair) Lori Queisser Senior Vice President, Global Compliance and Business Practices Schering-Plough Corporation Kenilworth, NJ (Co chair) |
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10:45 a.m. ![]() |
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Keynote Address: Performance with Integrity Sir Christopher Gent Chairman, GlaxoSmithKline London, UK |
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11:30 a.m. ![]() ![]() |
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Report on Results on International Pharmaceutical Compliance Survey Keith M. Korenchuk, JD, MPH Of Counsel, Covington & Burling LLP Washington, DC, USA Brian Riewerts Partner, Life Sciences Advisory Group PricewaterhouseCoopers LLP Baltimore, MD, USA Please contact Keith Korenchuk at kkorenchuk@cov.com or Brian Riewerts at brian.riewerts@us.pwc.com for a copy of the survey results. |
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12:15 p.m. |
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Networking Luncheon |
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1:15 p.m. ![]() |
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Industry Image and Trust from a European Perspective Reinhard Angelmar The Salmon and Rameau Fellow in Healthcare Management and Professor of Marketing INSEAD Fontainebleau, France Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:00 p.m. ![]() |
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Codes of Conduct Heather Simmonds Director, Prescription Medicines Code of Practice Authority London, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:30 p.m. ![]() ![]() ![]() ![]() ![]() |
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Panel Discussion: Role of Company Compliance Programs vs. IFPMA and EFPIA; Taking Advantage of the Synergies Sue Egan Compliance Officer, Pharma Europe GlaxoSmithKline, London, UK David O'Shaughnessy Compliance Officer, Pharmaceuticals International GlaxoSmithKline, London, UK Heather Simmonds Director, Prescription Medicines Code of Practice Authority London, UK Roeland Van Aelst Executive Director, Health Care Compliance, Europe, Middle East, Africa Johnson & Johnson Brussels, Belgium Ted Acosta, Esq. Principal, Ernst & Young LLP New York, NY, USA (Moderator) Panel Discussion Only - No Presentations Provided |
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3:30 p.m. |
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Break |
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4:00 p.m. ![]() ![]() ![]() ![]() |
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Emerging Issues in Europe Panel Alastair G. Benbow, MB, BS, MRCP, FFPM Vice President and European Medical Director GlaxoSmithKline Pharmaceuticals Brentford, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) Linda R. Horton, Esq. Partner, Hogan & Hartson LLP Former Director, International Policy Food and Drug Administration Brussels, Belgium and Washington, DC, USA Presentation Material (Acrobat) Presentation Material (Powerpoint) John Smart Partner, Fraud Investigation and Dispute Services Ernst & Young London, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) Sue Egan Compliance Officer, Pharma Europe GlaxoSmithKline London, UK (Moderator) |
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4:45 p.m. ![]() ![]() ![]() ![]() ![]() |
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Emerging Issues in Latin America Panel Hector Armengod, Esq. Attorney at Law, Hogan & Hartson LLP Member of the Madrid Bar Brussels, Belgium Gonzalo Cornejo Vice President and Associate General Counsel Latin America & Canada Legal Operations International & Japan GlaxoSmithKline Philadelphia, PA Juan Francisco Millan, MD Executive Director CETIFARMA (Pharma Industry Association) Mexico Presentation Material (Acrobat) Presentation Material (Powerpoint) Larry Montes, MBA Executive Director Health Care Compliance Latin America and Canada Johnson & Johnson Guaynabo, PR, USA David O'Shaughnessy Compliance Officer, Pharmaceuticals International GlaxoSmithKline London, UK (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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5:30 p.m. ![]() ![]() ![]() |
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Emerging Issues in Asia/Pacific Panel Kevin Espinoza Consultant, Global Compliance Solutions Eli Lilly and Company Indianapolis, IN, USA Zhou Zheng Hao Area Compliance Officer, Eli Lilly and Company Bangkok, Thailand Yuet-Ming Tham Regional Compliance Director, Pfizer Hong Kong, China Karen Lowney Director, International Compliance Schering-Plough Corporation Kenilworth, NJ (Moderator) Panel Discussion Only - No Presentations Provided |
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6:15 p.m. |
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Adjournment and Company Best Practice Policy and Procedure Poster Board and Exchange Reception The International Pharma Congress Networking Reception will feature the exchange and presentation of company best practice policy and procedures at poster boards throughout the Pharma Congress Exhibit Hall. |
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