The Second Annual Pharmaceutical Industry Regulatory & Compliance Summit
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  Preconference

  Day One

  Day Two

 

Day 2
Tuesday, June 12, 2001


8:00 a.m.

WELCOME

8:00 - 9:15 a.m.

Lessons from Health Care Compliance
John Markus, Esq.
Senior Vice President
Fresenius Medical Care North America

Anthony O. Boswell, Esq.
Corporate Compliance Officer and Corporate Counsel
Laidlaw, Inc.

Vickie McCormick, Esq.
Integrity Officer
UnitedHealth Group

Roy Snell
Chief Executive Officer
Health Care Compliance Association (Moderator)

9:15 - 9:30 a.m.

TRANSITION BREAK

9:30 - 10:30 a.m.

CONCURRENT SESSIONS 3


301. Compliance Strategies for Clinical Trials
Michele Russell-Einhorn, J.D.
Director
PricewaterhouseCoopers

Leslie A. Platt, Esq.
Principal & Leader
Health Sciences Research Compliance Group
Ernst & Young, LLP
Presentation Material A
Presentation Material B


302. The Global Impact of the Internet on the Pharmaceutical Industry
Keith Korenchuk, Esq.
Partner, DavisWrightTremaine
Chairperson for the Global Alliance for eCommerce Law
Presentation Material


303. Developing an Effective Compliance Training Program
Victoria Wesseler
President
Ethics & Compliance Strategies
Presentation Material


304. Government Contracting Compliance
James P. Gallatin, Jr., Esq.
Partner
Reed Smith, LLP

Robert M. Jenkins, III, Esq.
Partner
Mayer Brown & Platt
Presentation Material A
Presentation Material B

10:30 - 11:00 a.m.

TRANSITION BREAK

11:00 a.m. -
12:00 p.m.

CONCURRENT SESSIONS 4


401. Compliance 202: Assessing the Effectiveness of your Compliance Program
Steven S. Diamond, Esq.
Partner
Arnold & Porter

Paul J. Silver
Director
Health Sciences Litigation Advisory Services
Ernst & Young, LLP
Presentation Material A
Presentation Material B


402. Negotiating and Living Under a Corporate Integrity Agreement
Brent Saunders, J.D., M.B.A.
Director
PricewaterhouseCoopers and Founder
Privacy Officers Association

Paul E. Kalb, J.D., M.D.
Partner
Sidley Austin Brown & Wood
Presentation Material A
Presentation Material B


403. Responding to a Governmental Investigation: Record Retention, Search Warrants and Subpoenas, Grand Jury Representations and Settlement Strategies
Peter Crane Anderson, Esq.
Partner, Davis Wright Tremaine
Former Assistant United States Attorney

Richard L. Cys, Esq.
Partner, Davis Wright Tremaine
Former Assistant United States Attorney

David V. Marshall, Esq.
Partner
Davis Wright Tremaine
Former Assistant United States Attorney

Charles P. Murdter, Esq.
Of Counsel
Davis Wright Tremaine
Former Trial Attorney
Department of Justice
Presentation Material


404. GxP Compliance for Computerized Systems
David L. Stone
General Manager Validation Services
Glemser Technologies Corporation
Presentation Material

12:30 - 3:00 p.m.

LUNCH AND PRESENTATIONS

12:30 - 1:30 p.m.

The Government's Use of Technology in Fraud and Abuse Control
Richard P. Kusserow
President
Strategic Management Systems, Inc.
Former Inspector General
Department of Health and Human Services

1:30 - 3:00 p.m.

Qui Tam Panel
Mark A. Kleiman, Esq.
Partner
Mark Allen Kleiman

Stephen L. Meagher, Esq.
Partner
Phillip & Cohen

Zachary Bentley
President
Venacare

Paul E. Kalb, J.D., M.D.
Partner
Sidley Austin Brown & Wood
(Moderator)

3:00 - 3:30 p.m.

TRANSITION BREAK

3:30 - 4:30 p.m.

CONCURRENT SESSIONS 5


501. A Program for Compliance with 21 CFR Part 11
Patrick D. Roche
Senior Manager
Global Risk Management Solutions
PricewaterhouseCoopers

Robert L. Steinmeier
Corporate 21 CFR Part 11 Program Director
Abbott Laboratories
Presentation Material


502. Building a Privacy Program
Stephen W. Bernstein, Esq.
Partner
McDermott, Will & Emery

Roger W. Louis, Esq.
Chief Compliance Officer
Genzyme Corporation
Presentation Material


503. Issues and Compliance Strategies Related to Medicaid Pricing
Carolyn McElroy, Esq.
Mintz Levin Cohn Ferris Glovsky & Popeo
Former Director of the Medicaid Fraud Control Unit for the State of Maryland
Presentation Material


504. Public Sector Pharmaceutical Pricing Issues: VA, DOD, PHS and Medicaid
Frank M. Rapoport, Esq.
Partner
McKenna & Cuneo
Past Chairman
American Bar Association
Health Care Contracting Committee
Presentation Material

4:30 p.m.

CONFERENCE ADJOURNS


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