10:30 – 10:40

Welcome & Format Review
Amy Matey, Seton Hall Law School

10:45 - 11:30

The Relationship Between Ethics and Legal Compliance
Professor Jacob Elberg, Seton Hall Law School

11:35 - 12:40

Navigating State, Federal & International Transparency Disclosure Requirements
John Oroho, Porzio Life Sciences, LLC
Keren Bisnauth, Porzio Life Sciences, LLC

12:40 - 1:25

Break

1:25 - 2:40

Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Anna Spencer, DLA Piper LLP

2:45 - 3:50

An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers
Philo Hall, Epstein Becker & Green, P.C.

3:50 - 4:05

Break

4:05 - 5:00

Government Pricing Regulation: Key Issues for Compliance Professionals
Kathleen Peterson, Hogan Lovells

10:30 - 11:30

The False Claims Act and Dealing with Whistleblowers
Meredith Auten, Morgan, Lewis & Bockius LLP
Pamela Coyle Brecht, Pietragallo Gordon Alfano Bosick & Raspanti, LLP

11:35 - 12:45

The Federal Anti-Kickback Statute
Marc Larkins, Johnson & Johnson
Bruce Levy, Gibbons P.C.

12:45 - 1:30

Break

1:30 - 2:35

Choose a Track:

Track 1: FDA Regulation of Drug Development & Approval
Professor Jennifer Oliva, Seton Hall Law School

Track 2: FDA Regulation of Medical Devices
Scott Danzis, Covington & Burling LLP

2:40 - 3:35

A Journey to the Dark Side of International Business: Real-World Risk and Real-World Lessons
Richard Bistrong, CEO, Front-Line Anti-Bribery LLC; former FCPA Violator & FBI/UK Cooperator

3:35 - 3:50

Break

3:50 - 5:00

The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
Stephanie Busalacchi, Johnson & Johnson
Gary Giampetruzzi, Paul Hastings LLP

10:30 - 11:25

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Nikki Reeves, King & Spalding LLP
Gillian Russell, King & Spalding LLP

11:30 - 12:10

Compliance Considerations in the New Age of Patient Advocacy
Liz Lewis, Takeda
Prof. Jacob Elberg, Seton Hall Law School

12:10 - 12:55

Break

12:55 - 2:00

Data Analytics
Michael Driscoll, Johnson & Johnson
Prof. Jacob Elberg, Seton Hall Law School
Anna Loveless, Johnson & Johnson

2:00 - 2:15

Break

2:15 - 3:45

Compliance Case Study Workshop

3:50 - 5:00

Compliance Officers Panel Discussion
Regina Cavaliere, Roche Diagnostics Corp.
Michael Clarke, ConvaTec
Jill Fallows Macaluso, Novo Nordisk
Joe Zimmerman, Ferring Pharmaceuticals, Inc.
Moderator: Prof. Jacob Elberg, Seton Hall Law School

11:00 - 11:50

Compliance Lessons Learned from Corporate Integrity Agreements
Seth Lundy, King & Spalding LLP

11:55 - 1:00

AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Jeff Layne, Reed Smith

1:00 - 1:45

Break

1:45 - 2:35

Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
Rachael Honig, U.S. Attorney’s Office, District of New Jersey

2:40 - 3:25

Before I Was a Compliance Officer …
Jim Sheehan, New York Attorney General’s Office

3:25 - 3:35

Break

3:35 - 4:55

Panel Discussion: Being the Focus of a Government Investigation
Laurie Allen, Federal Bureau of Investigation
Rachael Honig, U.S. Attorney’s Office, District of New Jersey
Jenny Kramer, Alston & Bird
Scott McBride, Lowenstein Sandler P.C.
Jim Sheehan, New York Attorney General’s Office
Moderator: Prof. Jacob Elberg, Seton Hall Law School

4:55 - 5:00

Concluding Remarks