| 9:00
a.m. - 7:00 p.m. |
Preconference
Programs Optional Concurrent Sessions; Space Limited
Early Registration
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|
10:00
a.m. - 5:00 p.m.
Lunch included |
Preconference
Compliance Session
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1.
|
Creating
a Successful Comprehensive Compliance Program for Pharmaceutical
and Health Care Products Manufacturers
(1.5 Hours)
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This
session will focus on how to develop, implement and operate a successful
compliance program in the pharmaceutical industry. Hear from industry
experts about what works and what does not. Learn about tools for
assessing and measuring, tracking and operating your program. |
| |
|
Eve
Costopouls, Esq.
Legal Director Compliance Schering-Plough Corp.
Kenneworth, NJ |
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Tim
Romps, J.D., M.B.A.
Chief Compliance Officer & Ombudsman
Bayer Corporation
Pittsburgh, PA |
| |
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Eric
Siegel, Esq.
Compliance Attorney SmithKline Beecham
Philadelphia, PA |
| |
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Caroline
West, Esq.
Associate General Counsel Compliance
Rhone-Poulenc Rorer, Inc.
Collegeville, PA |
| |
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Dion
P. Shiedy (Moderator)
Partner, PricewaterhouseCoopers LLP
Compliance and Operational Controls
Health Care Regulatory Group
Pittsburgh, PA
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2. |
Building
Effective Corporate Compliance Program Solutions for Pharmacy Benefit
Management Companies
(1.5 Hours)
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How
are prescription benefit management companies developing compliance
program solutions for the increasing political, legal, public relations
and marketplace pressures they face?
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Russell
Farr
Legal Counsel
PCS Health Systems
Scottsdale, AZ
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Diane
Nobles
Senior Vice President of Compliance and Integrity & Chief Compliance
Officer
Caremark, Inc.
Northbrook, IL .
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Mamie
S. Segall, Esq. (Moderator)
Gray, Plant, Mooty, Mooty & Bennett, P.A. Former Compliance Officer
Diversified Pharmaceutical Services, Inc.
Minneapolis, MN
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3. |
Legal,
Regulatory and Enforcement Developments in the Pharmaceutical Industry
† What You Must Know
(1.5 Hours)
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Pharmaceutical
and health care products companies operate in an environment where
constant change and innovation are the norm. However, constant change
can create new and different business and legal risks that can have
significant operational effects if left unchecked. Learn about the
latest issues under scrutiny by the FDA, Department of Justice and
the Office of Inspector General.
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Joseph
W. Metro, Esq.
Partner, Reed Smith Shaw & McClary, LLP
Washington, DC
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Edwin
D. Rauzi, Esq.
Partner, Davis Wright Tremaine LLP
Seattle, WA
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Helen
Trilling, Esq.
Hogan & Hartson L.L.P
Washington, DC
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Brent
Saunders, J.D., M.B.A. (Moderator)
Director, PricewaterhouseCoopers LLP
President, Health Care Compliance Association
Washington, DC
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4.
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Surviving
Subpoenas, Search Warrants and Investigative Demands: The Internal
Investigation
(1.5 Hours)
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Learn
how to perform an internal investigation, conduct a sensitive compliance
audit, and analyze high risk reports to reduce exposure. Moreover,
hear how to respond when the government arrives and learn the proactive
techniques to respond appropriately.
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Lanny
A. Breuer, Esq.
Partner, Covington & Burling
Washington, DC
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Paul
E. Kalb, M.D.
Partner, Sidley & Austin
Washington, DC
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Charles P. Murdter, Esq.
Of Counsel, Davis Wright Tremaine LLP
San Francisco, CA
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W.
McKay Henderson (Moderator)
Partner, PricewaterhouseCoopers LLP
Washington, DC
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