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Day II: Tuesday, October 28, 2008 |
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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 Bert Weinstein, Esq. Vice President, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair) |
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8:15 a.m.       |
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PCF Pharmaceutical Compliance Professional and Legal Counsel Roundtable: Preparing for the Next Wave of Change Brian Riewerts Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP, Washington, DC (Moderator/Co chair) Gerald F. Masoudi, Esq. Chief Counsel, Food and Drug Administration, Former Deputy Assistant Attorney General, International, Policy and Appellate Matters, Antitrust Division, US Department of Justice, Rockville, MD Lori Queisser Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation, Kenilworth, NJ Arjun Rajaratnam, Esq. Vice President & Compliance Officer - US Pharmaceuticals, GlaxoSmithKline, Research Triangle Park, NC 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 Doreen F. Shulman Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb Bert Weinstein, Esq. Vice President, Corporate Compliance, Purdue Pharma LP, Stamford, CT |
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9:15 a.m. |
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Transition Break |
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PHARMA CONGRESS MORNING TRACK SESSIONS |
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Morning Track I:    |
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Sales and Marketing Compliance Update Track Co Chairs:
Partner, Ropes & Gray, Washington, DC (Co chair) Edward Miller, Esq. Vice President, Associate General Counsel and Chief Compliance Officer, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT (Co chair) Lawrence P. Platkin, Esq. Vice President and Compliance Officer, Bayer HealthCare LLC, Wayne, NJ (Co chair) |
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9:30 a.m. |
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Sales & Marketing Compliance Lessons from Recent Developments: Recent Settlements, CIAs; Compliance Challenges in Implementing the Revised PhRMA Code; FDA Draft Guidance on Off-Label Dissemination; AAAMC Report on Industry Funding of Medical Education; Access Issues and Industry Responses; and Sunshine Act and State Transparency Laws Gregory H. Levine, Esq. Partner, Ropes & Gray, Washington, DC Edward Miller, Esq. Vice President, Associate General Counsel and Chief Compliance Officer, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT Lawrence P. Platkin, Esq. Vice President and Compliance Officer, Bayer HealthCare LLC, Wayne, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:30 a.m. |
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State Laws: Assessing Challenges, What's Ahead: State Reporting Implementation Challenges - Dealing with Incomplete Data; Specific Challenges Requiring Legal Interpretation; Tracking Total Spend; Effectiveness of State Reporting Requirements in Changing Company Practices; and Future Areas of State Focus Regina Cavaliere, Esq. Vice President and Senior Counsel, Health Care Law Compliance, Pharmaceuticals, Alpharma Pharmaceuticals LLC, Bridgewater, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) Ann Lewis, Esq. Counsel, Ropes & Gray LLP, New York, NY Una Nash Associate Director, Compliance-Marketing and Sales, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT |
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11:30 a.m. |
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Panel Discussion/Q&A |
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12:00 p.m. |
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Proceed to Networking Luncheon |
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Morning Track II:   |
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Research, Development and Clinical Trials Compliance Update Track Co Chairs:
Vice President, Legal Affairs and Chief Compliance Officer, Sanofi Pasteur Inc., Swiftwater, PA (Co chair) Meredith Manning, Esq. Partner, Hogan & Hartson, LLC, Former Assistant US Attorney, Civil Division for the US Attorney's Office, Former Associate Chief Counsel, Food and Drug Administration, Washington DC (Co chair) |
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9:30 a.m. |
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Current Compliance Challenges Timothy Cleary, Esq. Vice President, Legal Affairs and Chief Compliance Officer, Sanofi Pasteur Inc., Swiftwater, PA Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:00 a.m. |
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Assessing Future Regulatory and Compliance Developments: Complying Clinical Trial Reporting Obligations Theresa A. Toigo, MBA, R.Ph. Director, Office of Special Health Issues, Director, Office of Women's Health, Food and Drug Administration, Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:30 a.m. |
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GAP Analysis: How we Get to Where we Want to be - Managing GCP Inspections Pre-Approval Robert F. Church, Esq. Partner, Hogan & Hartson, LLP, Former Associate Chief Counsel for Drugs, Food and Drug Administration, Los Angeles, CA Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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11:00 a.m. |
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The Intersection of the False Claims Act and FDA's Authority over Clinical Trials Peter S. Spivack, Esq. Partner, Hogan & Hartson, LLP, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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11:30 a.m. |
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FDA and Duke University's Clinical Trials Initiative Rachel E. Behrman, MD, MPH Director, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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12:00 p.m. |
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Proceed to Networking Luncheon |
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Morning Track III:   |
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The "411" on Government Price Reporting: What Every Compliance Professional Needs to Know Track Co Chairs:
Managing Director, Huron Consulting Group, LLC, New York, NY (Co chair) Alice Valder Curran Hogan & Hartson, LLC, Partner, Washington, DC (Co chair) |
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9:30 a.m. |
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Introductions Tim Nugent Managing Director, Huron Consulting Group, LLC, New York, NY (Co chair) Alice Valder Curran Hogan & Hartson, LLC, Partner, Washington, DC (Co chair) |
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9:45 a.m. |
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Current Compliance Challenges - Developing a Robust Compliance Framework for Price Reporting Using the OIG's Seven Elements Tim Nugent Managing Director, Huron Consulting Group, LLC, New York, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:15 a.m. |
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Assessing Future Regulatory and Compliance Developments - An Assessment of the Current Landscape and Future Legislative Changes Medicaid, Medicare, and VA Price Reporting Obligations Alice Valder Curran Partner, Hogan & Hartson, LLC, Partner, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Allison Pugsley, Esq. Attorney-at-Law, Hogan & Hartson, LLP, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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11:15 a.m. |
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Practical Case Study: A Compliance Professional's Playbook on Conducting a Pricing Assessment Jessica A. Gottlieb, Esq. Director & Associate Counsel, Marketing Compliance, Barr Laboratories, Inc., Former Associate Counsel at Roche Pharmaceuticals, Montvale, NJ Tim Nugent Managing Director, Huron Consulting Group, LLC, New York, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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12:00 p.m. |
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Proceed to Networking Luncheon |
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Morning Track IV:   |
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Relationships with Healthcare Professionals Compliance Update Track Co Chairs:
Vice President, Corporate Compliance, Schering-Plough Corporation, Kenilworth, NJ (Co chair) Jack T. Tanselle Director, Navigant Consulting, Inc., Chicago, IL (Co chair) |
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9:30 a.m. |
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Emerging (Regulatory and Prosecutorial) Focus on Physicians Geoffrey Kaiser Managing Director, Healthcare Dispute, Compliance and Investigations Practice, Navigant Consulting, Inc., New York, NY Erin Reilly Lewis Counsel, Health and Life Sciences Practice, Baker & Daniels, LLP, Indianapolis, IN No PowerPoint presentation provided |
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10:15 a.m. |
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Orthopedics Panel: Learning from the Implementation to Comply with Settlement Requirements Sujata T. Dayal Partner, Karmact, LLC, Chicago, IL Saul Helman Managing Director, Navigant Consulting, Inc., Chicago, IL John P. Inglesino, Esq. Member, Stern & Kilcullen, LLC, Roseland, NJ No PowerPoint presentation provided |
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11:00 a.m. |
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Facilitated Dialogue: Managing and Preparing for More Change: A Survey/ Interactive Discussion on Gaps and Best Practices Regarding: Fair Market Value; CEO/Other Certification; Training: Reps, Speakers, Others; and Monitoring |
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12:00 p.m. |
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Proceed to Networking Luncheon |
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Morning Track V:   |
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Emerging Compliance Challenges Track Co Chairs:
Partner, PricewaterhouseCoopers LLP, Florham Park, NJ (Co chair) Daniel A. Kracov, Esq. Partner, Arnold & Porter, Washington, DC (Co chair) |
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9:30 a.m. |
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Executive Liability: Beyond the Park Doctrine Vernessa Thomas Pollard, Esq. Counsel, Arnold & Porter LLP, Former Associate Chief Counsel, Food and Drug Administration, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:10 a.m. |
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Relationships between Pharmaceutical Companies and Research Publications Daniel A. Kracov, Esq. Partner, Arnold & Porter, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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10:45 a.m. |
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Maintaining Compliance in a Changing World Peter Claude Partner, PricewaterhouseCoopers LLP, Florham Park, NJ |
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11:15 a.m. |
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The Implementation of Fair Market Value: What Can We Learn From Recent Enforcement Actions? Abhiroop Gandhi Associate Director, Commercial Compliance, Actelion Pharmaceuticals US, Inc., South San Francisco, CA Debjit A. Ghosh Life Sciences Advisory Services, Huron Consulting Group, LLC, New York, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) Vickie McCormick Vice President, Health Care Compliance, DePuy Orthopaedics, Warsaw, IN |
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12:00 p.m. |
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Proceed to Networking Luncheon |
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Morning Track VI: |
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Interactive International Case Studies Covering a Range of Topics to Include: Distribution Channel Challenges; Third Party Oversight (Including Use of HCPs as Third Parties, and Anti-bribery and Anti-corruption Considerations); Organization of International Congresses and Conferences for HCP Attendance; and Management of Allegations and Investigations |
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9:30 a.m.    |
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Track Co Chairs:
Vice President Compliance, AstraZeneca PLC, London, UK (Co chair) Keith M. Korenchuk, JD, MPH Of Counsel, Covington & Burling LLP, Washington, DC (Co chair) Presentation Material (Acrobat) Presentation Material (Powerpoint) Michael Shaw Global Head, Ethics and Compliance, Novartis Oncology, Former Senior Counsel, Office of Inspector General, Department of Health and Human Services, Florham Park, NJ (Co chair) Doreen F. Shulman Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ (Co chair) |
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12:00 p.m. |
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Proceed to Networking Luncheon |
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SPECIAL BOX LUNCH REPORT |
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12:00 p.m.  |
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Special Box Lunch Report: New Theories of Prosecution Under False Claims Act Paul E. Kalb, JD, MD Partner, Sidley Austin LLP, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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PHARMA CONGRESS AFTERNOON TRACK SESSIONS |
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Afternoon Track I:  |
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Pharmacovigilance and Drug Safety Compliance Update Track Co Chairs:
Director of Outcomes and Analysis Corporate Compliance, Amgen, Thousand Oaks, CA, (Co chair) Meredith Manning, Esq. Partner, Hogan & Hartson, LLC, Washington, DC (Co chair) |
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1:15 p.m. |
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Current Compliance Challenges Robert F. Church, Esq. Partner, Hogan & Hartson, LLC, Former Executive Director, Global Research and Development Compliance Department, Amgen, Former Associate Chief Counsel for Drugs, Food and Drug Administration, Los Angeles, CA Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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1:45 p.m. |
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Assessing Future Regulatory and Compliance Developments Beverly H. Lorell, MD Senior Medical and Policy Advisor, FDA/Healthcare Practice Group, King & Spalding, Former Vice President and Global Chief Medical, and Technology Officer, Guidant Corporation, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:15 p.m. |
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GAP Analysis: How we Get to Where we Want to Be John P. Ford, Esq. Counsel, Sidley Austin LLP, Former Senior Democratic Counsel, Energy and Commerce Committee, United States House of Representatives, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:45 p.m. |
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REMS Suzanne Barone, PhD Team Leader, Food and Drug Administration, CDER, Office of Compliance, Silver Spring, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3:15 p.m. |
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Sentinel Program Karen C. Lee, MD, MPH Medical Epidemiologist, Office of Critical Path Programs, US Food and Drug Administration, Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3:45 p.m. |
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Break |
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Afternoon Track II:   |
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Working with Third Parties, Vendors and Strategic Partners Track Co Chairs:
Senior Director, Business Practices, Genentech, San Francisco, CA (Co chair) Paul J. Silver Managing Director, Huron Consulting Group, LLC, Atlanta, GA (Co chair) |
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1:15 p.m. |
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Current Compliance Challenges Involved in Working With Third Parties - What Things Should We Worry About? David Davidovic Senior Director, Business Practices, Genentech, San Francisco, CA Paul J. Silver Managing Director, Huron Consulting Group, LLC, Atlanta, GA Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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1:45 p.m. |
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Due Diligence Monitoring and Auditing of Third Party Vendors Diana Borges Compliance Manager, Teva North America, North Wales, PA Brian Dahl Director of Compliance, Teva Phamarceuticals, Kansas City, MO Michele Girdharry Manager, Huron Consulting Group, LLC, New York, NY Paul Silver Managing Director, Huron Consulting Group, LLC, Atlanta, GA (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:45 p.m. |
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Robust Agreements and Vendor Training: When, Where and How Janis Crum, Esq. Associate Director of Auditing, Genentech, South San Francisco, CA Mark DeWyngaert, PhD Managing Director, Huron Consulting Group, LLC, New York, NY Ned Kelly, MD Vice President, Pharmacovigilance, Quintiles, Research Triangle Park, NC Presentation Material (Acrobat) |
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3:45 p.m. |
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Break |
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Afternoon Track III:    |
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Creating an Environment for Productive Post-Settlement Interactions with the Government: CIAs, DOJ Monitors and Disclosures Track Co Chairs:
Partner, Ernst & Young LLP, Atlanta, GA (Co chair) Michael Dusseau Executive Director, Compliance Services, Global Compliance and Business Practices, Schering-Plough Corporation, Kenilworth, NJ (Co chair) Lynn Shapiro Snyder, Esq. Partner, Epstein Becker & Green, New York, NY (Co chair) |
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1:15 p.m. |
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The Government Perspective Thomas A. Gregory, CPA, CFA Partner, Ernst & Young LLP, Atlanta, GA Daniel R. Miller, Esq. Deputy Attorney General and Director, Medicaid Fraud Control Unit, Delaware Department of Justice, President, National Association of Medicaid Fraud Control Units (NAMFCU), Wilmington, DE Jeffrey M. Senger, Esq. Deputy Chief Counsel, Food and Drug Administration, Former Senior Counsel to the Associate Attorney General, US Department of Justice, Rockville, MD Presentation Material (Acrobat) Presentation Material (Powerpoint) Lynn Shapiro Snyder, Esq. Partner, Epstein Becker & Green, New York, NY (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:30 p.m. |
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The Industry Perspective Thomas E. Costa, Esq. Vice President, US Pharmaceuticals Compliance & Ethics, Bristol-Myers Squibb, Princeton, NJ Presentation Material (Acrobat) Presentation Material (Powerpoint) Kathy DiGiorno Vice President and Chief Ethics and Compliance Officer, Medtronic, Inc, Minneapolis, MN Thomas A. Gregory, CPA, CFA Partner, Ernst & Young LLP, Atlanta, GA Lynn Shapiro Snyder, Esq. Partner, Epstein Becker & Green, New York, NY Michael Dusseau Executive Director, Compliance Services, Global Compliance and Business Practices, Schering-Plough Corporation, Kenilworth, NJ (Moderator) |
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3:45 p.m. |
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Break |
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Afternoon Track IV:   |
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FCPA Compliance Update Track Co Chairs:
Chief Integrity and Compliance Officer, Lilly Research Laboratories (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) Joseph B. Tompkins, Jr., Esq. Partner, Sidley Austin LLP, Former Deputy Chief, Fraud Section, Department of Justice, Washington, DC (Co chair) |
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1:15 p.m. |
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Overview of the FCPA: Scope, Key Definitions, Exceptions and Affirmative Defenses, Books and Record Keeping Requirements, and Interaction with Anti-bribery Laws in Other Countries Joseph B. Tompkins, Jr., Esq. Partner, Sidley Austin LLP, Former Deputy Chief, Fraud Section, Department of Justice, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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1:45 p.m. |
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Current Trends in Enforcement/Recent Cases: Industry Sweeps, Including Pharma and Medical Device Industries, Increased Extra-territorial Reach, Increased Collaboration Between DOJ and SEC, Imposition of Independent Monitors, Increased Focus on Fines, etc. for Individuals, not Just Companies, Discussion of Recent Enforcement Actions - Pleas, Sanctions Imposed, etc. Stephen L. Braga, Esq. Partner, Ropes & Gray, Adjunct Professor, Georgetown University Law Center, Washington, DC Colleen A. Conry, Esq. Partner, Ropes & Gray, Former Prosecutor, Fraud Section, Criminal Division, US Department of Justice, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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2:15 p.m. |
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Implementing an Effective Anti-Corruption Compliance Program - Lessons Learned Michael Bridwell Global Manager, Compliance and Ethics Program Development, Eli Lilly and Company, Indianapolis, IN John Kuckelman, Esq. Global Anti-Corruption and International Trade, Regulations Counsel, International Legal, Eli Lilly and Company, Indianapolis, IN Permission to post not granted |
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2:45 p.m. |
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Issues in Conducting FCPA Investigations Outside the US and How to Deal with Them: Data Protection/Privacy Laws in Non-US Jurisdictions; Privilege Issues in Multi-national Investigations, Collecting, Reviewing and Retrieving Electronic and Hard-copy Documents; Issues in Interviewing Witnesses Outside the US, and Dealing with the DOJ and SEC while Conducting an Investigation Sandee I. Priser, JD, CPA Partner, Fraud Investigation and Dispute Services, Ernst & Young LLP, Chicago, IL Leslie A. Shubert, Esq. Partner, Sidley Austin LLP, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3:15 p.m. |
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The Importance of FCPA Due Diligence in International Mergers, Acquisitions and Joint Venture Leslie A. Shubert, Esq. Partner, Sidley Austin LLP, Washington, DC Joseph B. Tompkins, Jr., Esq. Partner, Sidley Austin LLP, Former Deputy Chief, Fraud Section, Department of Justice, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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3:45 p.m. |
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Break |
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Afternoon Track V: |
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Interactive Domestic Case Studies Covering a Range of Sales & Marketing "Hot" Topics such as: Speaker Management Issues; In-Office Interactions; Conflicts of Interest with Customers; Firewall Issues Related to Marketing/Medical Vendors; and PhRMA Code Issues Pre- and Post- implementation. |
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1:15 p.m. |
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Track Co Chairs:
Vice President Compliance, AstraZeneca PLC, London, UK (Co chair) Keith M. Korenchuk, JD, MPH Of Counsel, Covington & Burling LLP, Washington, DC (Co chair) Presentation Material (Acrobat) Presentation Material (Powerpoint) Michael Shaw Global Head, Ethics and Compliance, Novartis Oncology, Former Senior Counsel, Office of Inspector General, Department of Health and Human Services, Florham Park, NJ (Co chair) Doreen F. Shulman Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb, Princeton, NJ (Co chair) |
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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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Introduction to Afternoon Plenary Session Bert Weinstein, Esq. Vice President, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair) |
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4:30 p.m.  |
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How Government Uses Data in Analyzing Illegal Activities James G. Sheehan, Esq. New York State Medicaid, Inspector General, Former Associate United States Attorney, U.S. Attorney's Office, Eastern District of Pennsylvania, Albany, NY Presentation Material (Acrobat) Presentation Material (Powerpoint) |
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5:00 p.m. |
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Adjournment and Company Best Practice Policy and Procedure Poster Board and Exchange Reception The Pharma Congress Tuesday Networking Reception will feature the exchange and presentation of company best practice policy and procedures at poster boards throughout the Pharma Congress Exhibit. Margaret Feltz Associate Director, Corporate Compliance, Purdue Pharma LP, Stamford, CT (Co chair)
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