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PHARMA CONGRESS SPRING 2003:  HHS OIG COMPLIANCE GUIDANCE FOR THE PHARMACEUTICAL INDUSTRY: KEY INSIGHTS FROM REGULATORS AND COMPLIANCE EXPERTS

The Fourth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum

Renaissance Marriott Hotel
Washington, DC

November 12-14, 2003

Sponsored by


Diamond Grantors



Platinum Grantors


Gold Grantors


Silver Grantors





Co-Sponsored by
Association of Clinical Research Professionals
Food and Drug Law Institute
International Federation of Pharmaceutical Manufacturers Associations
International Pharmaceutical Privacy Consortium
IRB Forum
Pharmacy & Therapeutics (P&T) Society
Society of Research Administrators International (SRA)

The Acumen Journal of Life Sciences
American Pharmaceutical Review
BNA's Pharmaceutical Law & Industry Report
BNA's Medical Research Law & Policy Report
CenterWatch Monthly Newsletter
Clinical Trials Advisor
Drug and Market Development Publications
FDACompliance.Net
FDA News
Genaissance Health Care Partners
Harvard Health Policy Review
Health Affairs
Human Research Report
JobWatch Clinical Research Careers Monitor
Journal of Pharmaceutical Development and Regulation
Med Ad News
Pharma Marketing Network
Pharma Marketing News
Pharma Privacy Watch
Pharmaceutical Executive Magazine
PharmaVOICE

STREAMING VIDEO OF PRESENTATION BY OIG CHIEF COUNSEL LEW MORRIS

As Seen on Pharma Congress Spring 2003 CD-ROM Described below.

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SAVE THE DATE
The Fifth Annual Pharmaceutical Regulatory and Compliance Congress

Sponsored by Pharmaceutical Compliance Forum and PricewaterhouseCoopers

November 14 - 17, 2004

Washington, DC

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The Fourth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum

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ATTENDEE RESPONSE RESULTS FROM PHARMA CONGRESS
Throughout the Pharma Congress faculty polled attendees regarding certain regulatory and compliance Concerns. Attendee response is set forth in graphic form. These real time audience response results were generated by MERIDIA Audience Response, www.meridiaARS.com. MERIDIA is an interactive meeting consulting company which specializes in providing an audience with instant feedback throughout the conference



- Click here to see Attendee Response Results -

Keynote Speakers:

Thomas L. Abrams
Director, Division of Drug Marketing, Advertising & Communications, U.S. Food and Drug Administration, Rockville, MD

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

Dara Corrigan
Acting Principal Deputy Inspector General, Office of Inspector General, Department of health and Human Services, Washington, DC

Virginia Gibson, Esq.
Assistant U.S. Attorney, Chief, Civil Division, Eastern District of Pennsylvania, Philadelphia, PA

Raymond Gilmartin
Chairman, President and CEO, Merck & Co., Inc., Whitehouse Station, NJ

John Guthrie, Esq.
Director, Medicaid Fraud Control Unit, Office of Attorney General, Columbus, OH

Thomas B. Leary, Esq.
Commissioner, Federal Trade Commission, Washington, DC

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

Mark B. McClellan, MD, Ph.D.
Commissioner of Food and Drugs, Food and Drug Administration, Rockville, MD

Dennis M. Nally
Chairman and Senior Partner, PricewaterhouseCoopers LLP, New York, NY

Janet Rehnquist, Esq.
Partner, Venable LLP, Former Inspector General, Department of Health & Human Services, Washington, DC

Thomas Scully
Administrator, Center for Medicare and Medicaid Services, Department of Health and Human Services,Washington, DC

James Sheehan, Esq.
Chief of the Civil Division, Assistant U.S. Attorney, U.S. Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA

Janet Woodcock, MD
Director, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD

Congress Co-chairs:

Douglas M. Lankler, Esq.
Senior Corporate Counsel, Deputy Compliance Officer, Pfizer Inc., New York, NY

Arjun Rajaratnam, Esq.
Compliance Officer, Global Pharmaceuticals, GlaxoSmithKline, Research Triangle Park, NC

Bert Weinstein, Esq.
Vice President and Assistant General Counsel, Merck & Co., Whitehouse Station, NJ

Featured Faculty:

Joan Antokol
Chief Privacy Officer, Novartis, East Hanover, NJ

Alexis Leslie Barbieri, Esq.
Deputy Attorney General, Office of Attorney General, Harrisburg, PA

Tom Behan
Compliance Director, AstraZeneca, Wilmington, DE

John Bentivoglio, Esq.
Partner, Arnold and Porter, Former Special Counsel for Healthcare Fraud, Chief Privacy Officer, United States Department of Justice, Washington, DC

Raymond A. Bonner, Esq.
Partner, Sidley Austin Brown & Wood, Washington, DC

Mary Devlin Capizzi, Esq.
Partner, Gardner Carton & Douglas, Washington, DC

Heidi Chen, Esq.
Senior Corporate Counsel, Pfizer Inc., New York, NY

John Clay
Senior Adviser, E-Business, North American Commercial Operations, Aventis Pharmaceuticals, Bridgewater, NJ

Eve Costopoulos, Esq.
Staff Vice President, Compliance, Schering-Plough Corporation, Law Department, Kenilworth, NJ

David A. Crenshaw, Esq.
Legal Director, European Operations, Schering-Plough, Kenilworth, NJ

Stanley W. Crosley, Esq.
Chief Privacy Officer, Eli Lilly and Company, Law Division, Indianapolis, IN

Teri Crouse, Esq.
Director of Compliance for Healthcare and Marketing, Eli Lilly and Company, Indianapolis, IN

Brian A. Dahl, Esq.
Counsel, Takeda Pharmaceuticals North America, Inc., Lincolnshire, IL

Sujata T. Dayal Esq.
Counsel, Domestic Legal Operations, Abbott Laboratories, Abbott Park, IL

Joseph Famulare
Director, Division of Manufacturing and Product Quality, Office of Compliance, FDA Center for Drug Evaluation and Research, Rockville, MD

Anthony L. Farino
Partner, PricewaterhouseCoopers, Chicago, IL

William T. Fitzgerald, Esq.
Director, Global Compliance, Alcon Laboratories, Inc., Fort Worth, TX

Allison J. Gassaro Esq.
Senior Attorney, NA Legal, Aventis Pharmaceuticals, Bridgewater, NJ

Gary Giampetruzzi, Esq.
Compliance Counsel, Pfizer Inc., New York, NY

Robert G. Homchick, Esq.
Partner and Chair, Health Law Group, Davis Wright Tremaine, Seattle, WA

Peter Barton Hutt, Esq,
Partner, Covington & Burling, Former Chief Counsel, Food and Drug Administration, Washington, DC

Oliver Johnson, II
Chief Privacy Officer, Merck & Co., Whitehouse Station, NJ

Paul E. Kalb, MD, JD
Partner, Sidley Austin Brown & Wood, Washington, DC

Thomas E. Kanwit
Assistant U.S. Attorney, Health Care Fraud Unit, District of Massachusetts, Boston, MA

Richard F. Kingham
Partner, Covington & Burling, Washington, DC

Mark Allen Kleiman, Esq.
Partner, Law Offices of Mark Allen Kleiman, Los Angeles, CA

Kathleen A. Knight, Esq.
Vice President, Deputy General Counsel and Assistant Secretary, Alcon Laboratories, Inc., Fort Worth, TX

Richard P. Kusserow
President, Strategic Management Systems, Inc., Former Inspector General, Department of Health & Human Services, Washington, DC

Arthur N. Levine, Esq.
Partner, Arnold & Porter, Former Deputy Chief Counsel for Litigation, Food and Drug Administration, Washington, DC

Robert S. Litt, Esq.
Partner, Arnold & Porter, Former Principal Associate Deputy Attorney General, United States Department of Justice, Washington, DC

Justin McCarthy Esq.
Assistant General Counsel, Global Research and Development, Pfizer Inc., New London, CT

Stephen Meagher, Esq.
Partner, Phillips & Cohen, San Francisco, CA

Ed Miller, Esq.
Boehringer Ingelheim Pharmaceuticals

David Moskowitz, MBA, R.PH
Senior Vice President and Healthcare Senior Analyst, Friedman, Billings, Ramsey Group, Inc., Washington, DC

Edwin D. Rauzi, Esq.
Partner, Davis Wright Tremaine, Seattle, WA

Pat Roche
Partner, PricewaterhouseCoopers, Florham Park, NJ

Peter O. Safir
Partner, Covington & Burling, Washington, DC

Brenton L. Saunders, JD, MBA
Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation, Past President, Health Care Compliance Association, Founder and Chair-elect, International Association of Privacy Officers, Kenilworth, NJ

Catherine A. Sazdanoff
Divisional Vice President, Ethics and Compliance, Abbott Laboratories, Abbott Park, IL

Dalton Smart, CPA, MBA
Senior Director and Compliance Officer, Schering-Plough International, Kenilworth, NJ

Jonathan A. Smollen
Chief Privacy Officer, Wyeth Pharmaceuticals, St. Davids, PA

Steve Sokolow
Vice President and Head of Litigation, Novartis Pharmaceuticals Corporation, East Hanover, NJ

Ian Spatz
Vice President, Public Policy, Merck & Co., Inc., Washington, DC

Bert Spilker, PhD, MD, FCP, FFPM
President, Bert Spilker & Associates, Clinical Professor, Pharmacy Practice, University of Minnesota, Former Senior Vice President of Scientific and Regulatory Affairs, PhRMA, Bethesda, MD

Jane Stratton, Esq.
Vice President Associate General Counsel, And Chief Compliance Officer, Chiron Corporation, Emeryville, CA

Michael P. Swiatocha
Director, PricewaterhouseCoopers, Florham Park, NJ

Paul A. Sundberg Esq.
Staff Counsel, Commercial Legal Operations, Takeda Pharmaceuticals North America, Inc., Lincolnshire, IL

L. Stephan Vincze, Esq.
Ethics & Compliance Officer, TAP Pharmaceuticals, Lake Forest, IL

Caroline H. West, Esq.
Vice President, Global Legal Compliance, Legal Compliance Group, Aventis Pharmaceuticals, Bridgewater, NJ



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