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Pre-Conference/
Day One

Day Two

Day Three
 

Agenda: Day 2
Thursday, November 14, 2002



8:00 a.m.

Welcome and Introductions

Valli Baldassano
Senior Director Global Compliance
Associate General Counsel, Pharmacia
Peapack, NJ
(Conference Co chair)

8:15 a.m.

Corporate Responsibility in the Pharmaceutical Industry

Fred Hassan
Chairman and Chief Executive Officer
Pharmacia Corporation
Chairman, Pharmaceutical Research & Manufacturers of America (PhRMA)
Peapack, NJ

9:00 a.m.

Compliance Officer Roundtable: Best Practices Exchange

Valli Baldassano, Esq.
Senior Director Global Compliance and Associate General Counsel
Pharmacia Corporation
Bedminster, NJ

Douglas Lankler, Esq.
Corporate Counsel
Corporate Compliance
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., Inc.
Whitehouse Station, NJ

Brent Saunders, JD, MBA
Partner, PricewaterhouseCoopers, LLP
Florham Park, NJ
(Moderator)

10:15 a.m.

Break

10:45 a.m.

Concurrent Session I



1.01 Perspective on Pharmaceutical Sales and Marketing Practices

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



1.02 Compliance Reporting and Auditing: Best Practice Exchange

Peter Claude
Senior Manager
PricewaterhouseCoopers LLP

Anthony Farino
Partner
PricewaterhouseCoopers, LLP
Chicago, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.03 Compliance Issues and Strategies for Clinical Research

Seth Whitelaw
Compliance Officer
Global R&D
GlaxoSmithKline
Philadelphia, PA
Presentation Material A (Acrobat)
Presentation Material A (Powerpoint)
Presentation Material B (Acrobat)
Presentation Material C (Acrobat)
Presentation Material C (Microsoft Word)

Heather Stewart, Esq.
Senior Associate
Porter Wright Morris & Arthur, LLP
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



1.04 Part 11 Compliance and other Related Issues - A Panel Discussion

Ron Lee
Director, 21 CFR Part 11/Annex 11 Program Office
Chiron
San Francisco, CA

Robert Steinmeier
21 CFR Part 11 Program Manager
Abbott Laboratories
Abbott Park, IL

Peter Tarasov
AstraZeneca

Patrick A. Roche
Senior Manager
Global Risk Management Solutions
PricewaterhouseCoopers, LLP
Florham Park, NJ
(Moderator)
Presentation Material (Acrobat)
Presentation Material (Powerpoint)




1.05 Negotiating Fraud Settlements

Stuart Kurlander, Esq.
Partner
Latham & Watkins
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

Noon

Lunch

12:30 p.m.

Introductory Comments

Douglas Lankler, Esq.
Corporate Counsel, Compliance
Pfizer, Inc.
New York, NY
(Conference Co chair)

12:45 p.m.

Lunch Keynote Speaker

Uwe E. Reinhardt, Ph.D.
James Madison Professor of Political Economy
Woodrow Wilson School
Princeton University
Princeton, NJ

1:30 p.m.

Lunch Presentation: The New Role of Corporate Ethics

Jacqueline Brevard, Esq.
Chief Ethics Officer
Merck & Co.
Whitehouse Station, NJ

Diane Nobles
Senior Vice President for Compliance and Integrity
Caremark Rx
Chicago, IL

Brenda Hildreth
Manager, Business Practices
Baxter International Inc.
Deerfield, IL

Steve Priest
President
Ethical Leadership Group
Chicago, IL
(Moderator)

2:30 p.m.

Break

2:45 p.m.

Concurrent Sessions II



2.01 When Pharmaceutical Marketing Crosses the Line: Best Practices for Investigation and Remediation

Edward R. Malone, Esq.
Jenner & Block, LLC
Chicago, IL

Mark A. Pollack, Esq.
Partner
Jenner & Block, LLC
Chicago, IL
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Presentation Material (Acrobat)
Presentation Material (Microsoft Word)



2.02 Compliance Program Effectiveness - Is Your Compliance Program Where it Should Be?

Eve Costopoulos, Esq.
Senior Legal Director
Compliance
Schering-Plough Corporation
Kenilworth, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2.03 Corporate Compliance vs. Enterprise Wide Risk Management

Brent Saunders, JD, MBA
Partner, PricewaterhouseCoopers, LLP
Founder and 1st VP
International Association of Privacy Officers
Past President
Health Care Compliance Association
Florham Park, NJ
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2.04 Hot Topics: OIG Model Guidance, Recent Issues and More...

John Bentivoglio, Esq.
Partner, Arnold & Porter
Former Special Counsel for Health Care Fraud
Chief Privacy Officer, Department of Justice
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)



2.05 Clinical Research Compliance: Human Subject Protections

Tom Puglisi, Ph.D.
Clinical Research Consulting Team
PricewaterhouseCoopers, LLP
Former Director of Human Subject Protections for the Office for Human Research Protections
Department of Health and Human Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)


4:00 p.m.

Break

4:15 p.m.

What the Election Results Will Mean For Health Care

Gail R. Wilensky, Ph.D.
John M. Olin Senior Fellow, Project HOPE
Co-Chair, President's Task Force to Improve Health Care Delivery for Our Nation's Veterans
Former Administrator, Health Care Financing Administration (HCFA)
Former Chair Medicare Payment Advisory Commission
And Physician Payment Review Commission
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:15 p.m.

Adjournment and Networking Reception

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