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Day II: Thursday, November 12, 2009 |
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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 Margaret K. Feltz Associate Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair) |
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8:15 a.m. |
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OIG Update Mary E. Riordan, Esq. Senior Counsel, Office of Counsel to the Inspector General, Office of Inspector General, Department of Health and Human Services, Washington, DC Presentation Material (Acrobat) |
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9:15 a.m. |
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DOJ Civil Division Update Tony West, Esq. Head, Civil Division, US Department of Justice; Former California Special Assistant Attorney General; Former Assistant US Attorney, Northern California, Washington, DC Presentation Material (Acrobat) |
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9:45 a.m. |
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DOJ Criminal Division Update Lanny A. Breuer, Esq. Head, Criminal Division, US Department of Justice; Former Special White House Counsel; Former Assistant District Attorney, New York City, Washington, DC Presentation Material (Acrobat) |
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10:15 a.m. |
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Break |
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10:45 a.m. |
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Making the Case for Compliance: A US Attorney's Perspective Patrick L. Meehan, Esq. Partner, Conrad O'Brien Gellman & Rohn, Former United States Attorney, Eastern District of Pennsylvania, Philadelphia, PA Presentation Material (Acrobat) |
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11:15 a.m. |
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SEC Enforcement Update Lorin L. Reisner, Esq. Deputy Director of Enforcement, US Securities and Exchange Commission; Former Assistant United States Attorney, Southern District of New York, Washington, DC Presentation not provided |
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12:00 p.m. |
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Networking Luncheon |
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DAY II AFTERNOON TRACK SESSIONS |
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Afternoon Track I: |
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Compliance Program Elements: How to Implement and Enhance a Pharmaceutical Compliance Program to Meet Evolving Regulatory Standards (Continued) |
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1:00 p.m. |
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How to Receive Allegations of Compliance Violations and Conduct Investigations Mary Ann Northrup Associate Director, Navigant, Inc., Chicago, IL Chuck Rosenberg, Esq. Partner, Hogan & Hartson LLP; Former US Attorney, Eastern District of Virginia; Former US Attorney, Southern District of Texas, Washington, DC Presentation Material (Acrobat) Jeffery D. Williams, Esq. Assistant General Counsel, Pfizer Inc., New York, NY Presentation Material (Acrobat) |
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1:45 p.m. |
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How to Design and Conduct an Effective Compliance Auditing and Monitoring Program A. Monica Jonhart Senior Director, Healthcare Auditing & Monitoring, Otsuka America Pharmaceutical, Inc., Princeton, NJ Chris Santarcangelo Assistant Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT Presentation Material (Acrobat) |
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2:30 p.m. |
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How to Communicate and Collaborate with Colleagues in Related Functions and Departments Saul B. Helman, MD Managing Director, Navigant Consulting, Inc., Chicago, IL Robert M. Trotta, II Senior Director, Compliance and Ethics, Bristol-Myers Squibb, Princeton, NJ Presentation Material (Acrobat) |
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3:15 p.m. |
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How to Communicate with the Board of Directors About your Compliance Program Saul B. Helman, MD Managing Director, Navigant Consulting, Inc., Chicago, IL Doreen F. Shulman Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ Presentation Material (Acrobat) |
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3:45 p.m. |
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Break |
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Afternoon Track II: |
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An Integrated Approach to Compliance: Addressing Healthcare Fraud and Abuse Compliance Risks Throughout a Product's Lifecycle (Continued) |
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1:00 p.m. |
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Advanced Issues in Managed Care and Reimbursement 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) Eric Siegel Chief Compliance Officer, EMD Serono, Inc., Rockland, MA Presentation Material (Acrobat) |
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2:00 p.m. |
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Impact of REMs Program Requirements to Pharma Karla Stricker Anderson Managing Director, PricewaterhouseCoopers LLP, McLean, VA Presentation Material (Acrobat) Michael Giffin Director of Life Sciences, World Class International, New York, NY Presentation Material (Acrobat) |
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3:00 p.m. |
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Wrap-up Faculty Panel Discussion |
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3:45 p.m. |
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Break |
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Afternoon Track III: |
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Transparency and Third Party Compliance Requirements (Continued) |
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1:00 p.m. |
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Overview of Day Two Presentation Material (Acrobat) |
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1:10 p.m. |
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Developing a Global Approach for Third-Party Due Diligence Programs William R. Baker, III, Esq. Partner, Latham & Watkins, Washington, DC Colleen A. Conry, Esq. Partner, Ropes and Gray, LLP, Washington, DC Sofia Halfmann Director, Compliance, Global Medical Affairs, Global Compliance & Business Practices, Schering-Plough Corporation, Kenilworth, NJ |
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2:00 p.m. |
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Aggregate Spend & State Reporting - Do You Know Where Your Third Parties Are? Michael Bell President, R-Squared, Princeton Junction, NJ Marci Juneau Huron Consulting Group, New York, NY Eric Siegel US Chief Compliance Officer, EMD Serono, Inc., Rockland, MA Presentation Material (Acrobat) |
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2:45 p.m. |
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Harmonization of FMV Policies & Procedures Internally and With Your Third Party Vendors Jeffrey J. Brady President, Advanced Health Media, LLC, Bridgewater, NJ Brian A. Dahl, Esq. Director of Compliance, Teva North America, Kansas City, MO Meghan Davis Manager, Life Sciences Advisory Services, Huron Consulting Group, New York, NY Paul J. Silver Managing Director, Practice Leader, Life Sciences Advisory Services, Huron Consulting Group, Atlanta, GA (Moderator) Presentation Material (Acrobat) |
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3:45 p.m. |
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Break |
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Afternoon Track IV: |
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Instituting a Truly Global Compliance Program (Continued) |
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1:00 p.m. |
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Recap and Review of Day 1 by Co chairs |
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1:15 p.m. |
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DOJ's New FCPA Initiative on Pharma and Device Manufacturers Steve Kim, Esq. Trial Attorney, Fraud Section, US Department of Justice, Former Assistant United States Attorney, Eastern District of New York, Washington, DC Kirk Ogrosky, Esq. Deputy Chief, Fraud Section, US Department of Justice, Washington, DC Presentation Material (Acrobat) Caroline West Senior Vice President, Chief Compliance and Risk Officer, Shire Pharmaceuticals, Inc., Wayne, PA (Moderator) Presentation Material (Acrobat) |
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2:15 p.m. |
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Anti-Bribery Concerns: FCPA and Beyond Greg Crouse, CPA Partner, Pharmaceutical Compliance Investigative & Dispute Services, Ernst & Young, Washington, DC R. Scott Meece, Esq. General Counsel and Senior Vice President, Bayer Healthcare LLC, Tarrytown, NY Presentation Material (Acrobat) |
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3:00 p.m. |
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Panel Discussion: Lessons from the Trenches - Brazil and China Jose Alexandre Buaiz Neto, Esq. Partner, Pinheiro Neto Advogados, Brazil Presentation Material (Acrobat) Jack C. Silhavy, Esq. Assistant General Counsel, Astellas US LLC, Deerfield, IL Presentation Material (Acrobat) |
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3:45 p.m. |
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Break |
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AFTERNOON PLENARY SESSION |
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4:15 p.m. |
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Afternoon Plenary Session: Updates and Best Practices Reports from the Track Co chairs |
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5:15 p.m. |
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Adjournment |
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