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Agenda: Pre-Conference
Wednesday, November 12, 2003
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PRECONFERENCE SYMPOSIA
OPTIONAL CONCURRENT SESSIONS
9:00 am to Noon (choose one session only)
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9:00 a.m. |
Preconference I: A Compliance Primer for the Pharmaceutical Sector
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Michael P. Swiatocha
Director, PricewaterhouseCoopers
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)
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9:00 a.m. |
Preconference II: FDA Regulatory and Enforcement Update
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Joseph Famulare
Director, Division of Manufacturing and Product Quality
Office of Compliance
FDA Center for Drug Evaluation and Research
Rockville, MD
Thomas E. Kanwit
Assistant U.S. Attorney
Health Care Fraud Unit
District of Massachusetts
Boston, MA
Michael Labson
Partner, Covington & Burling
Washington, DC
Peter O. Safir
Partner, Covington & Burling
Washington, DC
Peter Barton Hutt, Esq.
Partner, Covington & Burling
Former Chief Counsel
Food and Drug Administration
Washington, DC
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)
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9:00 a.m. |
Preconference III: Developing and Implementing an International Pharmaceutical Compliance Program
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David A. Crenshaw, Esq.
Legal Director, European Operations
Schering-Plough
Lucerne, Switzerland
Dalton Smart, CPA, MBA
Senior Director and Compliance Officer
Schering-Plough International
Kenilworth, NJ
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9:00 a.m. |
Preconference IV: Pharmaceutical Compliance Issue Update: Pricing, Off Label Marketing, and Kickbacks
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John Bentivoglio, Esq.
Partner, Arnold and Porter
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
Presentation Material A (Acrobat)
Presentation Material A (Powerpoint)
Presentation Material B (Acrobat)
Presentation Material B (Powerpoint)
Anthony L. Farino
Partner, PricewaterhouseCoopers
Chicago, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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Agenda: Day 1
Wednesday, November 12, 2003
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PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS AND BEST PRACTICES FORUM
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1:30 p.m. |
Welcome and Introduction
Bert Weinstein, Esq.
Vice President and Assistant General Counsel
Merck & Co.
Whitehouse Station, NJ
(Conference Co chair)
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1:45 p.m. |
Corporate Responsibility in the Pharmaceutical Enterprise
Raymond Gilmartin
Chairman, President and CEO
Merck & Co., Inc.
Whitehouse Station, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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2:30 p.m. |
Enforcement in the Pharmaceutical Industry
Dara Corrigan
Acting Principal Deputy Inspector General
Office of Inspector General
Department of Health and Human Services
Washington, DC
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3:15 p.m. |
Break
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3:45 p.m. |
Regulating the Pharmaceutical Development Enterprise
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research
Food and Drug Administration
Rockville, MD
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4:30 p.m. |
Ethical Issues in the Development, Marketing and Sales of Pharmaceuticals
Arthur L. Caplan, Ph.D.
Director, Center for Bioethics, University of Pennsylvania
Fellow, American Association for the Advancement of Science, the Hastings Center, the College of Physicians of Philadelphia, and the New York Academy of Medicine
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
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5:15 p.m. |
Pharmaceutical Sector Regulator Roundtable
Virginia Gibson, Esq.
Assistant U.S. Attorney
Chief, Civil Division
Eastern District of Pennsylvania
Philadelphia, PA
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
John Guthrie, Esq.
Director, Medicaid Fraud Control Unit
Office of Attorney General
Columbus, OH
Michael Loucks, Esq.
Chief of the Health Care Fraud Unit
Assistant U.S. Attorney
U.S. Attorney's Office for the District of Massachusetts
Boston, MA
John Bentivoglio, Esq.
Partner, Arnold & Porter
Former Special Counsel for Health Care Fraud
Chief Privacy Officer, Department of Justice
Washington, DC
(Moderator)
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6:30 p.m. |
Adjournment and Networking Reception
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