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8:00 a.m. |
WELCOME AND INTRODUCTION
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8:00 a.m. |
The OIG'S Enforcement Initiatives in the Pharmaceutical Industry
Lewis Morris, Esq.
Assistant Inspector General for Legal Affairs
Office of the Inspector General
US Department of Health and Human Services
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8:30 a.m. |
State Enforcement Initiatives in the Pharmaceutical Industry
David Waterbury, Esq.
Senior Counsel
Washington State Attorney General's Office
Medicaid Fraud Control Unit
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9:00 a.m. |
A Federal Prosecutor's Perspective on the Pharmaceutical Industry
James Sheehan, Esq.
Assistant United States Attorney
United States Attorney's Office
Eastern District of Pennsylvania
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9:30 a.m. |
Insights into the Department of Justice's Initiatives
Michael K. Loucks, Esq.
Health Care Fraud Chief
United States Attorney's Office
District of Massachusetts
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10:00 a.m. |
REFRESHMENT BREAK
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10:30 a.m. |
Regulator Roundtable
Lewis Morris
David Waterbury
James Sheehan
Michael K. Loucks
Moderator: Michael Kendall, Esq.
Partner
McDermott, Will & Emery
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11:00 - 11:15 a.m. |
TRANSITION BREAK
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11:15 a.m. -
12:30 p.m. |
CONCURRENT SESSIONS 1
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101. Compliance Strategies under PDMA for Samples Management
Arjun Rajaratnam, Esq.
Compliance Officer
Global Pharmaceuticals
GlaxoSmithKline
Presentation Material A
Presentation Material B
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102. How to Conduct an Internal Investigation
Robert S. Litt, Esq.
Partner
Arnold & Porter
Former Deputy Assistant Attorney General
U.S. Department of Justice
Principal Associate Deputy Attorney General
Mark D. Pollack, Esq.
Partner
Jenner & Block
Presentation Material
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103. Conducting Compliance Risk Assessments: Issues & Strategies
Mary E. Riordan, Esq.
Senior Counsel
Office of Counsel to the Inspector General
HHS-OIG
Ted Acosta, Esq.
Senior Manager
Litigation Advisory Service
Ernst & Young, LLP
Presentation Material
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104. A Primer on Fraud and Abuse
Robert Fabrikant, Esq.
Partner
Sidley Austin Brown and Wood
Presentation Material
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12:30 - 2:30 p.m.
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LUNCH AND PRESENTATIONS
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1:15 - 2:15 p.m.
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Compliance Roundtable
Arjun Rajaratnam, Esq.
Compliance Officer
Global Pharmaceuticals
GlaxoSmithKline
Douglas M. Lankler, Esq.
Corporate Counsel
Compliance
Pfizer Inc
Charles M. Brock, Esq.
Chief Ethics and Compliance Officer
Abbott Laboratories
Roger W. Louis, Esq.
Chief Compliance Officer
Genzyme Corporation
John T. Bentivoglio, Esq.
Partner
Arnold & Porter
(Moderator)
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2:15 - 2:45 p.m.
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TRANSITION BREAK
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2:45 - 3:45 p.m. |
CONCURRENT SESSIONS 2
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201. Pharmaceutical Sales and Marketing Compliance
Anthony Farino
Partner
PricewaterhouseCoopers
Joseph W. Metro, Esq.
Partner
Reed Smith, LLP
Presentation Material
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202. Compliance 101: Implementing an Effective Compliance Plan
Deborah A. Randall, Esq.
Member Health Group
Arent Fox Kintner Plotkin & Kahn, PLLC
Brian Riewerts
Manager
Regulatory Compliance
PricewaterhouseCoopers
Presentation Material
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203. Compliance with FDA Labeling and Advertising Requirements
Richard J. Kenny, Jr., Esq.
Assistant General Counsel
AstraZeneca Pharmaceuticals, LP
Peter S. Reichertz, Esq.
Partner
Arent Fox Kintner Plotkin & Kahn, PLLC
Presentation Material A
Presentation Material B
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204. Strategic Defenses to Pharmaceutical Investigations
Michael Kendall, Esq.
Partner
McDermott, Will & Emery
Katherine A. Lauer, Esq.
Partner
Latham & Watkins
Presentation Material
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3:45 - 4:00 p.m. |
TRANSITION BREAK
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4:00 - 5:00 p.m. |
Hot Issues in the Pharmaceutical Industry Regulatory Environment
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5:00 p.m. |
ADJOURNMENT AND NETWORKING RECEPTION
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