11:00 - 11:10

Welcome & Format Review
Amy Matey, Seton Hall Law School

11:15 - 11:55

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

12:00 - 1:00

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

1:00 - 1:20

Break

1:20 - 1:50

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

1:55 - 2:35

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

2:40 - 3:30

Government Pricing Regulation: Key Issues for Compliance Professionals
Speaker TBA

11:00 - 12:00

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
Christopher Hanson, Covington & Burling LLP

12:05 - 12:35

The Federal Anti-Kickback Statute
Bruce Levy, Gibbons P.C.

12:40 - 1:40

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

11:50 - 12:50

The Perils of Dealing with Whistleblowers Under the False Claims Act
Pamela Coyle Brecht, Pietragallo Gordon Alfano Bosick & Raspanti, LLP

1:40 - 2:00

Break

2:00 - 2:40

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

2:45 - 3:45

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

11:00 - 11:45

Compliance Considerations in the New Age of Patient Advocacy
Speaker TBD

11:50 - 12:15

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Speaker TBD

12:20 - 1:30

Data Analytics
Stacy Aiken, Johnson & Johnson
Michael Driscoll, Johnson & Johnson
Prof. Jacob Elberg, Seton Hall Law School

1:30 - 1:50

Break

1:50 - 3:00

Compliance Case Study Workshop

3:00 - 4:00

Compliance Officers Panel Discussion
Regina Cavaliere, formerly of Esperion Therapeutics
Michael Clarke, ConvaTec
Charlene Davis, Aerie Pharmaceuticals, Inc.
Joe Zimmerman, Ferring Pharmaceuticals, Inc.
Moderator: Prof. Jacob Elberg, Seton Hall Law School

11:00 - 11:20

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

11:25 - 11:55

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

12:00 - 12:45

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

12:50 - 1:10

Health Care Fraud Sentencing, Penalties, Damages & Other Considerations
Scott McBride, Lowenstein Sandler LLP
Jenny Kramer, Alston & Bird
Joseph Mack, Bayer U.S.

1:10 - 1:25

Break

1:25 - 2:05

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

2:10 - 3:25

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

3:25 - 3:30

Concluding Remarks