文档介绍：The Pharma, Biotech and Device pliance Pre-Conference WorkshopMonday, June 6, 2005
Louise Mehrotra
VP WW Health pliance
Johnson & Johnson
A Primer pliance Programs for
Pharmaceutical and Medical Device
Companies
Kathy Lundberg
SVP/pliance Officer
Guidant Corporation
2004 Sales of $ Billion
Over 200 panies in 57 countries around the world
Leadership positions in ethical and OTC pharmaceuticals, medical/surgical supplies, diagnostics and a variety of consumer products
Broad based, diverse portfolio of products
World’s prehensive and Broadly Based Health pany
By Geographic Area
Trade Sales
2004
.
Europe
W. Hem (ex. US)
Asia Pacific & Africa
12%
5%
24%
59%
$ Billion
2004
Sales by Segment
%
%
%
MD&D
$ Billion
Pharmaceutical
$ Billion
Consumer
$ Billion
Guidant Corporation Structure
CRM
VI
ES
CS
CARDIAC RHYTHM
MANAGEMENT
ENDOVASCULAR
SOLUTIONS
CARDIAC
SURGERY
VASCULAR
INTERVENTION
COMPASS
Headquarters
Geographic Operations
Overview
Why pliance Programs Important?
History and Basics of the . mission Guidelines
HHS pliance Program pliance Program Basics
Written Standards of Conduct
Leadership and Infrastructure
Education and Training
munications and Reporting
Monitoring and Auditing
Enforcement of Disciplinary Standards
Responding to Detected Offenses
Concluding Thoughts
Why pliance Programs Important? (Or … Who Cares?)
Effective programs can prevent wrongdoing and lessen the damage when violations do occur.
A pliance program can be influential at key stages of the investigative and enforcement processes:
Whether to continue or expand an investigation
Whether to turn investigatory results over to prosecutors
Whether to charge pany with wrongdoing
Whether to pursue criminal or civil charges
Whether to settle a case and, if so, on what terms
Whether to pursue exclusion or debarment of pany
. mission Guidelines
The 1984 Sentencing Reform Act created the . mission and directed it to de