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Day II: Thursday, October 21, 2010 |
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7:00 a.m. |
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Registration Opens: Continental Breakfast in Exhibit Hall |
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MORNING PLENARY SESSION |
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8:00 a.m. |
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Welcome and Introduction to Day II Morning Plenary Session: Overview of the Sunshine Act Margaret K. Feltz Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair) Presentation Material (Acrobat) |
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8:15 a.m. |
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Global Transparency Management: 2010 Industry Survey Key Findings William E. Buzzeo, MS Vice President and General Manager Compliance Solutions Division, Cegedim Relationship Management, Richmond, VA Presentation Material (Acrobat) |
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8:30 a.m. |
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Roundtable on Federal Sunshine Act and State Disclosure Laws: Top Challenges and Compliance Best Practices Karen Lowney Senior Director, Global Compliance, Cephalon, Frazer, PA Rore Middleton, Esq. Senior Manager, Corporate Compliance, Purdue Pharma LP, Stamford, CT Kelly N. "Nikki" Reeves, MPA, JD Partner, King & Spalding LLP, Washington, DC Trudy J. Seeley, Esq. Compliance Manager, State Law Compliance and US Corporate Compliance, sanofi-aventis, Bridgewater, NJ Heidi Straub Senior Director, Physician Aggregate Spend Team (PhAST), Eli Lilly and Company, Indianapolis, IN Jack T. Tanselle, MBA Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Chicago, IL (Co moderator) David J. Wysocky Director, Pharmaceutical & Life Sciences Practice, PricewaterhouseCoopers LLP, Florham Park, NJ (Co moderator) |
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9:45 a.m. |
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Break |
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DAY II MORNING TRACK SESSIONS |
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MORNING TRACK I: |
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ADVANCED ISSUES IN AUDITING AND MONITORING Debjit A. Ghosh, MS, MPH Managing Director, Life Sciences Advisory Services, Huron Consulting Group, New York, NY (Co chair) A. Monica Jonhart Senior Director, Ethics, Quality & Compliance, Otsuka America, Princeton, NJ (Co chair) |
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10:15 a.m. |
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Overview of Monitoring and Auditing Debjit A. Ghosh, MS, MPH Managing Director, Life Sciences Advisory Services, Huron Consulting Group, New York, NY A. Monica Jonhart Senior Director, Ethics, Quality & Compliance, Otsuka America, Princeton, NJ Presentation Material (Acrobat) |
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10:45 a.m. |
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Mature Compliance Monitoring and Auditing Eileen Erdos Partner, Ernst & Young LLP, Cleveland, OH Kathleen Meriwether, Esq. Principal, Fraud Investigation & Dispute Services, Ernst & Young, Former Assistant United States Attorney, Eastern District of Pennsylvania, Department of Justice, Philadelphia, PA Debra Neumann Director, Corporate Compliance and Business Practices, Endo Pharmaceuticals, Chadds Ford, PA |
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11:15 a.m. |
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Advanced Issues in Monitoring and Auditing Best Practices Roundtable: Lessons Learned from Recent CIA's and DPA's A. Monica Jonhart Senior Director, Ethics, Quality & Compliance, Otsuka America Pharmaceutical, Inc., Princeton, NJ Gary Mendelsohn Assistant Field Director, Corporate Compliance, Astellas US LLC, Evanston, IL Presentation Material (Acrobat) Presentation Material (Acrobat) Amy Pawloski Director, US Pharmaceuticals Compliance and Ethics Monitoring, Bristol-Myers Squibb, Princeton, NJ Angela Rodin, MBA Vice President, Group Internal Audit, GlaxoSmithKline, Philadelphia, PA Chris Santarcangelo Assistant Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT Diane Tolzman Senior Director, Sales, Marketing and Global Compliance, Astellas US LLC, Vancouver, WA Rosemary E. Weghorst Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA (Moderator) Constance Wilkinson, Esq. Member of the Firm, EpsteinBeckerGreen, Washington, DC (Moderator) |
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12:15 p.m. |
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Proceed to Networking Luncheon |
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MORNING TRACK II: |
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INTERNAL AND EXTERNAL INVESTIGATIONS UPDATE John T. Bentivoglio, Esq. Partner, Skadden Arps LLP, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC (Co chair) Gary F. Giampetruzzi, Esq. Assistant General Counsel and Chief of Government Investigations, Pfizer, Inc., New York, NY (Co chair) |
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10:15 a.m. |
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The Basics of Governmental Investigations Elizabeth V. Jobes, Esq. Vice President and Compliance Officer, Adolor Corporation, Former Assistant District Attorney, Philadelphia, PA, Exton, PA Joshua S. Levy, Esq. Partner, Ropes and Gray, Former Assistant US Attorney, District of Massachusetts, US Department of Justice, Boston, MA Presentation Material (Acrobat) |
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10:45 a.m. |
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Handling Internal Investigations Joshua Drew, Esq. Director, Corporate Compliance & Business Practices, Endo Pharmaceuticals, Former Assistant US Attorney, US Attorney's Office, District of New Jersey, Former Trial Attorney at Fraud Section, Criminal Division, US Department of Justice, Chadds Ford, PA Presentation Material (Acrobat) |
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11:15 a.m. |
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State Investigations John T. Bentivoglio, Esq. Partner, Skadden Arps LLP, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice, Washington, DC Gary F. Giampetruzzi, Esq. Assistant General Counsel and Chief of Government Investigations, Pfizer, Inc., New York, NY Presentation Material (Acrobat) |
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11:45 a.m. |
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International Investigations Peter S. Spivack, Esq. Partner, Hogan Lovells US LLP, Former Assistant United States Attorney, Central District of California, Washington, DC Presentation Material (Acrobat) |
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12:15 p.m. |
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Proceed to Networking Luncheon |
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MORNING TRACK III: |
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RESEARCH & DEVELOPMENT AND CLINICAL TRIALS Anup Kharode Director, Pharmaceutical & Life Sciences Practice, PricewaterhouseCoopers LLP, Philadelphia, PA (Co chair) Laura A. Wittenauer Ethics and Compliance Officer, Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN (Co chair) |
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10:15 a.m. |
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Patient Recruitment Susan Barsky R&D Compliance and Process Manager, Shire Pharmaceuticals, Philadelphia, PA Presentation Material (Acrobat) |
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10:45 a.m. |
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Compliance Programs for Research and Development Organizations Kathryn A. Fillenwarth Advisor, LRL Ethics and Compliance, Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN Presentation Material (Acrobat) |
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11:15 a.m. |
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Clinical Trial Results Disclosure: A Case Study Anup Kharode Director, Pharmaceutical & Life Sciences Practice, PricewaterhouseCoopers LLP, Philadelphia, PA Permission to post presentation not granted |
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11:45 a.m. |
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Good Clinical Practice Compliance: Avoiding the Mistakes that can Derail your Business Maria Kennedy, Esq. Assistant General Counsel, Johnson & Johnson, New Brunswick, NJ Presentation Material (Acrobat) Gregory H. Levine, Esq. Partner, Ropes and Gray, Washington DC Presentation Material (Acrobat) |
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12:15 p.m. |
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Proceed to Networking Luncheon |
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MORNING TRACK IV: |
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ADVANCED COMPLIANCE STRATEGIES RE FEDERAL SUNSHINE ACT AND STATE DISCLOSURE LAWS |
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10:15 a.m. |
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Jennifer Colapietro Partner, Pharmaceutical and Life Sciences Practice, PricewaterhouseCoopers, LLP, Florham Park, NJ (Co chair) Heidi Straub Senior Director, Physician Aggregate Spend Team (PhAST), Eli Lilly and Company, Indianapolis, IN (Co chair) |
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10:25 a.m. |
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Strategic and Operational Challenges Resulting from the new PPACA Eric Baim Attorney at Law, Hogan Lovells US LLP, Washington, DC Jennifer Colapietro Partner, Pharmaceutical and Life Sciences Practice, PricewaterhouseCoopers LLP, Florham Park, NJ Presentation Material (Acrobat) |
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10:55 a.m. |
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Are you Ready to Audit your Aggregate Spend Processes and Systems: Key Steps you Need to Consider Now Eve Costopoulos, Esq. Vice President, Chief Ethics and Compliance Officer, Eisai, Inc., Woodcliff Lake, NJ Marci Juneau Manager, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA Joe Morrell Huron Consulting Group, New York, NY Presentation Material (Acrobat) |
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11:25 a.m. |
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Sunshine Provisions within PPACA/HCEARA and the Opportunity to Improve your HCP "System" Right Now Jack T. Tanselle, MBA Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Chicago, IL Presentation Material (Acrobat) |
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11:50 a.m. |
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Aggregate Spend and Disclosure Requirements - How Automated Reporting and Master Data Management Can Improve Compliance Don Soong Senior Director, Compliance Solutions Development, Cegedim Relationship Management, Bedminster, NJ Presentation Material (Acrobat) |
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12:15 p.m. |
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Proceed to Networking Luncheon |
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LUNCHEON AND PRESENTATION |
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12:15 p.m. |
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Luncheon Address: Liability for Individuals Paul E. Kalb, JD, MD Partner, Sidley Austin LLP, Washington, DC Presentation Material (Acrobat) |
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DAY II AFTERNOON TRACK SESSIONS |
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AFTERNOON TRACK I: |
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COMPLIANCE PROGRAM TRENDS AND BEST PRACTICES Mark A. DeWyngaert, MBA, PhD Managing Director, Huron Consulting Group, New York, NY (Co chair) Paul J. Silver Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, LLC, Atlanta, GA (Co chair) |
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1:15 p.m. |
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The Continuing Evolution of CIAs Thomas A. Gregory Partner, Ernst & Young, Atlanta, GA Retta M. Riordan, JD President, Riordan Consulting LLC, Former Business Ethics and Compliance Officer, Organon USA Inc., Westfield, NJ Presentation Material (Acrobat) |
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1:45 p.m. |
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Compliance Effectiveness and Board Certification Thomas D. Forrester, Esq. Vice President, US Corporate Compliance Officer, sanofi-aventis, Bridgewater, NJ Saul B. Helman, MD Managing Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Chicago, IL Presentation Material (Acrobat) |
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2:15 p.m. |
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Practical Compliance Implications of the Integrity Provisions under PPACA to Rx Wendy C. Goldstein, Esq. Member of the Firm, Epstein Becker & Green PC, New York, NY Presentation Material (Acrobat) |
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2:45 p.m. |
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Proactive Compliance Monitoring - Past, Present and Future Lori Alarimo, Esq. Senior Corporate Counsel, Promotional Quality Assurance, Pfizer Inc., New York, NY Presentation Material (Acrobat) |
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3:15 p.m. |
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Break |
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AFTERNOON TRACK II: |
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HEALTHCARE PROFESSIONALS COMPLIANCE UPDATE--THE HOTTEST EMERGING ISSUES IN INDUSTRY/HCP RELATIONSHIPS Thomas Glavin, Esq. Vice President and Deputy Compliance Officer, Shire Pharmaceuticals, Philadelphia, PA (Co chair) Ann E. Lewis, Esq. Counsel, Ropes and Gray, Former Vice-President and Senior Counsel, US Healthcare Law Compliance, Bristol-Myers Squibb, New York, NY (Co chair) Presentation Material (Acrobat) |
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1:15 p.m. |
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Investigator Sponsored Research, Clinical Trial Investigator Compliance and Compliance Issues in Research-Related Relationships Eve M. Brunts, Esq. Partner, Ropes and Gray, Boston, MA Presentation Material (Acrobat) |
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1:45 p.m. |
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Live Monitoring of Speaker Programs: Ways to Accomplish More during this Process Paul J. Silver Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA Kathy Tench Director, Huron Consulting Group, New York, NY Presentation Material (Acrobat) |
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2:15 p.m. |
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Industry Support for Authors and Publications: What Good Looks Like Albert F. Cacozza, Jr., Esq. Partner, Ropes and Gray, Former Counsel to the Subcommittee on Labor Committee on Labor and Human Resources, United States Senate, Washington, DC Presentation Material (Acrobat) |
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2:45 p.m. |
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Track Faculty Q&A |
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3:15 p.m. |
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Break |
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AFTERNOON TRACK III: |
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GOVERNMENT PRICE REPORTING: WHAT EVERY COMPLIANCE PROFESSIONAL NEEDS TO KNOW Jerry R. Wolf, MBA Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Philadelphia, PA (Co chair) Joseph J. Skupen Senior Director, US Corporate Compliance, sanofi-aventis US, Bridgewater, NJ (Co chair) |
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1:15 p.m. |
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Overview of Government Pricing Implications within PPACA/HCEARA Jerry Wolf Director, Healthcare Dispute, Compliance and Investigation Practice, Navigant Consulting, Inc., Philadelphia, PA Presentation Material (Acrobat) |
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1:45 p.m. |
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Pricing Issues and Compliance Post-Healthcare Reform John Gould Associate, Arnold & Porter, Washington, DC Presentation Material (Acrobat) |
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2:15 p.m. |
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Auditing the Government Price Reporting Changes Mandated by Health Reform Susan Dunne Director, Life Sciences Advisory Services, Huron Consulting Group, Washington, DC Joseph J. Skupen CPA, Senior Director, US Corporate Compliance, sanofi-aventis US, Bridgewater, NJ Presentation Material (Acrobat) |
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2:45 p.m. |
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Monitoring Better Practices: Key Risk Areas in Building Your Program Katherine Buckley Director, Pharmaceutical & Life Sciences Practice, PricewaterhouseCoopers LLP, Philadelphia, PA Sharon White Director, Pharmaceutical & Life Sciences Practice, PricewaterhouseCoopers LLP, Philadelphia, PA |
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3:15 p.m. |
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Break |
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AFTERNOON TRACK IV: |
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FCPA COMPLIANCE UPDATE Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter, Washington, DC (Co chair) Kathleen Meriwether, Esq. Principal, Fraud Investigation & Dispute Services, Ernst & Young, Former Assistant United States Attorney, Eastern District of Pennsylvania, Department of Justice, Philadelphia, PA (Co chair) Gonzalo M. Cornejo, Esq. Vice President and Associate General Counsel, GlaxoSmithKline, Philadelphia, PA (Co chair) |
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1:15 p.m. |
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Global Anti-Bribery: Anti-Corruption (ABAC) Compliance: Overview and Advanced Issues Keith M. Korenchuk, JD, MPH Partner, Arnold & Porter, Washington, DC Gonzalo M. Cornejo, Esq. Vice President and Associate General Counsel, GlaxoSmithKline, Philadelphia, PA Presentation Material (Acrobat) |
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2:00 p.m. |
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FCPA/Anti-bribery Compliance Assessments Gregory A. Crouse, CPA Partner, Pharmaceutical Compliance Investigative & Dispute Services, Ernst & Young LLP, Washington, DC Morgan Miller, Esq. Partner, Litigation Department, Paul, Hastings, Janofsky & Walker, LLP, Washington, DC Presentation Material (Acrobat) |
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2:45 p.m. |
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Faculty Q&A |
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3:15 p.m. |
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Break |
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AFTERNOON PLENARY SESSION |
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3:45 p.m. |
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Introduction to Afternoon Plenary Session Michael L. Shaw, Esq. Vice President & Compliance Officer, GlaxoSmithKline-NA Pharmaceuticals, Former Senior Counsel, Office of Inspector General, Philadelphia, PA (Co chair) |
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4:00 p.m. |
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Practical Perspectives on Global Compliance Gabor Danielfy Senior Director, Health Care Compliance and Privacy EMEA, Johnson & Johnson, Issy-les-Moulineaux, France Presentation Material (Acrobat) |
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4:30 p.m. |
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Global Compliance: Reports from the Field Asia: Scott Bass, Esq. Partner and Chair, Global Life Sciences Team, Sidley Austin LLP, Washington, DC Presentation Material (Acrobat) Gordon M. Chapman Executive Director, Compliance and Ethics, Asia Pacific, Bristol-Myers Squibb, New York, NY Presentation Material (Acrobat) Europe: Gabor Danielfy Senior Director, Health Care Compliance and Privacy EMEA, Johnson & Johnson, Issy-les-Moulineaux, France Presentation Material (Acrobat) Latin and South America: Juan Francisco Millan, MD Executive Director, CETIFARMA (Pharma Industry Association), Mexico City, Mexico Presentation Material (Acrobat) Middle East/Africa: Gabor Danielfy Senior Director, Health Care Compliance and Privacy EMEA, Johnson & Johnson, Issy-les-Moulineaux, France Moderator: Ted Acosta, Esq. Principal, Ernst & Young LLP, Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY and Paris, France Presentation Material (Acrobat) |
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5:45 p.m. |
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Adjournment Day II |
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