Day 1: Introduction and Overview

8:30 Registration Opens/Continental Breakfast

9:15 – 10:15 Introduction and Dramatization
Seton Hall Law School Faculty

10:15 – 10:30 Break

10:30 – 11:15 Payment Overview
Kathleen Boozang, Seton Hall Law School

11:15 – 12:00 Overview of State Law Compliance

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, PhD, JD, Booz Allen Hamilton

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 Sarbanes-Oxley and Healthcare Compliance
John Pennett, Amper, Politziner & Mattia

5:15 – 6:30 Cocktail party in Atrium
sponsored by Gibbons PC

Day 2: Understanding Drug and Device Development and Promotion

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

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
Lesley Ann Skillen, Getnick & Getnick

Day 3: The Anti-Kickback Statute, the Stark Law, and Privacy Laws as Applied to
           the Pharmaceutical and Device Industries

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, Blank Rome LLP

5:30 – 6:45 Mandatory Working Dinner – Fraud & Abuse Quiz Show (at Newark Club)
All available speakers

Day 4: Investigations & Enforcement

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, John Krayniak, Jack Hartwig

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