|
Day 1: Introduction and
Overview |
|
Time |
Topic |
Speakers/Facilitators |
|
8:30
|
Registration Opens and Continental Breakfast
|
|
|
9:15-10:15
|
Introduction and Dramatization
|
Seton Hall Law School Faculty
|
10:15-10:30
|
Break
|
|
10:30-11:15
|
Ethics & Compliance
|
Kathleen Boozang
Seton Hall Law School
|
11:15-12:00
|
Overview of State Law Compliance
|
Linda Pissott Reig
Porzio Bromberg & Newman |
12:00-1:00
|
Lunch
|
|
1:00-2:15
|
An Integral Approach to Healthcare Compliance Programs -
Dealing with the Gray Areas and Ethical Issues
|
Thomas Goddard, Ph.D., J.D.
Integral Healthcare Solutions
|
2:15-2:30
|
Break
|
|
2:30-4:00
|
Overview of Federal Health Care Programs for Drug and
Device Manufacturers
|
Lynn Shapiro Snyder
Epstein Becker & Green
|
4:00-4:15
|
Break
|
|
4:15-5:15
|
TBA
|
|
|
|
|
Day 2: Understanding Drug and
Device Development and Promotion |
|
Time |
Topic |
Speakers/Facilitators |
|
8:30
|
Continental Breakfast
|
|
9:00-10:00
|
Overview of Approval Process for New Drugs
|
Peter Safir
Covington & Burling |
10:00-10:10
|
Break
|
|
10:10-11:00
|
Overview of the Approval Process for New Devices
|
Eugene Lambert
Covington & Burling |
11:00-11:15
|
Break
|
|
11:15-12:00
|
Clinical Research Issues
|
Eugene Lambert & Peter Safir
Covington & Burling |
12:00-1:00
|
Lunch
|
|
1:00-1:50
|
Scientific and educational activities - CME, Promotional
Speaker Programs, Off-label promotion, Phase IV studies
|
Peter Safir
Covington & Burling
|
1:50-2:50
|
FDA Requirements for Advertising and Labeling
|
Stuart Portnoy, M.D.,
Biologics Consulting Group, Inc.
Chris Zalesky
Johnson & Johnson |
2:50-3:00
|
Break
|
|
3:00-3:30
|
Promotional Material Review Processes
|
Chris Zalesky
Johnson & Johnson |
3:30-3:45
|
Break
|
|
3:45-5:15
|
Introduction to the False Claims Act and the Perspective
of Qui Tam Relators' Counsel
|
Nicholas Harbist
Blank Rome LLP
|
|
Day 3: The
Anti-Kickback Statute and Privacy Laws as Applied to
the
Pharmaceutical and Device Industries |
|
Time |
Topic |
Speakers/Facilitators |
|
8:30
|
Continental Breakfast
|
|
9:00-11:00
|
The Anti-kickback Statute and the Safe Harbors
|
Bruce Levy
Gibbons PC
Mike Bell
Mintz Levin |
|
11:00-11:15
|
Break
|
|
11:15-12:30
|
Case Studies
|
Bruce Levy & Mike Bell
|
12:30-1:30
|
Lunch
|
|
1:30-2:30
|
The Foreign Corrupt Practices Act
|
Gary Giampetruzzi
Pfizer |
2:30-2:45
|
Break
|
|
2:45-3:45
|
Federal and State Privacy Laws
|
Simone Handler-Hutchinson
Seton Hall Law School |
3:45-4:00
|
Break
|
|
4:00-5:15
|
Understanding Industry Guidance(s)
|
Kevin McAnaney
Law Office of Kevin G. McAnaney
Katie McDermott
Sonnenshein Nath & Rosenthal |
5:30-6:30
|
Complimentary Cocktail Reception Sponsored by Gibbons PC
|
All available speakers
|
|
|
|
|
|
Day 4: Investigations &
Enforcement |
|
Time |
Topic |
Speakers/Facilitators |
8:30
|
Continental Breakfast
|
|
9:00-10:15
|
Federal and State Enforcement
|
Jim Sheehan
New York State Medicaid Inspector General
John Krayniak
New Jersey Medicaid Fraud Control Unit |
10:15-10:30
|
Break
|
|
10:30-12:30
|
Being the Focus of a Government Investigation - Panel
Discussion
|
Robert Hanna, Gibbons PC
John Krayniak, NJ Medicaid Fraud Control Unit
Jack Hartwig, Deloitte |
12:30-1:30
|
Lunch
|
|
1:30-2:30
|
Medicaid/Medicare Pricing and Other Data Submitted to the
Government
|
Carolyn McElroy
Pacific Pulmonary Services
|
2:30-2:45
|
Break
|
|
2:45-3:45
|
Actions, Penalties, Sentencing
|
Jack Hartwig, Deloitte
|
3:45
|
Concluding Remarks
|
|
|
|
|
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