文档介绍：The Pharma, Biotech and Device Colloquium Compliance Pre-Conference Workshop Monday, June 6, 2005
Louise Mehrotra
VP WW Health Care Compliance
Johnson & Johnson
A Primer on Compliance Programs for
Pharmaceutical and Medical Device
Companies
Kathy Lundberg
SVP/Chief Compliance Officer
Guidant Corporation
2004 Sales of $ Billion
Over 200 operating companies 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 Most Comprehensive and Broadly Based Health Care Company
.
By Geographic Area
Worldwide Net 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
.
Indiana-based company selling products in 100 countries around the world
Leader in design and manufacture of cardiac and vascular devices and therapies
Business units with up to 30 years experience in key markets
Over 12,000 employees worldwide
GDT traded on the NYSE and PCX
Guidant Corporate Profile
.
Guidant Corporation Structure
CRM
VI
ES
CS
CARDIAC RHYTHM
MANAGEMENT
ENDOVASCULAR
SOLUTIONS
CARDIAC
SURGERY
VASCULAR
INTERVENTION
COMPASS
Headquarters
Geographic Operations
.
Overview
Why are Compliance Programs Important?
History and Basics of the . Sentencing Commission Guidelines
HHS OIG Compliance Program Guidelines
Compliance Program Basics
Written Standards of Conduct
Leadership and Infrastructure
Education and Training
Internal Communications and Reporting
Monitoring and Auditing
Enforcement of Disciplinary Standards
Responding to Detected Offenses
Concluding Thoughts
.
Why Are Compliance Programs Important? (Or … Who Cares?)
Effective programs can prevent wrongdoing and lessen the damage when violations do occur.
A