8:30 - 9:00

Program Opens; Continental Breakfast

9:00 - 9:30

Program Introduction & Overview/Compliance Challenge
Amy Matey, Seton Hall Law School

9:30 - 10:20

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

10:20 - 10:40

Break

10:40 - 11:50

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

11:50 - 12:50

Networking Lunch

12:50 - 2:20

Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Speaker TBA

2:20 - 2:35

Break

2:35 - 3:55

An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers
Speaker TBA

3:55 - 4:15

Break

4:15 - 5:15

Government Pricing Regulation: Key Issues for Compliance Professionals
Speaker TBA

8:30 - 9:00

Continental Breakfast

9:00 - 10:15

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

10:15 - 10:35

Break

10:35 - 11:50

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

11:50 - 12:50

The Perils of Dealing with Whistleblowers Under the False Claims Act
Lawrence Del Rossi, Drinker Biddle & Reath LLP
Maureen Ruane, Health Care Consultant, Educator & Advisor

12:50 - 1:50

Networking Lunch sponsored by Paul Hastings LLP

1:50 - 2:50

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

2:50 - 3:05

Break

3:05 - 4:20

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

4:20 - 4:40

Break

4:40 - 5:30

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

8:30 - 9:00

Continental Breakfast

9:00 - 10:15

Compliance Considerations in the New Age of Patient Advocacy
Patrik Florencio, Amicus Therapeutics
Ellen Rosenberg, Amicus Therapeutics

10:15 - 10:35

Break

10:35 - 12:20

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Elizabeth Kim, Loeb & Loeb LLP

12:20 - 1:20

Networking Lunch

1:20 - 2:45

Data Analytics
Michael Driscoll, Johnson & Johnson
Professor Jacob Elberg, Seton Hall Law School

2:45 - 4:00

Compliance Case Study: Break-Out Session & Workshop

4:00 - 4:20

Break

4:20 - 5:35

Compliance Officers Panel Discussion
Charlene Davis, Sun Pharmaceutical Industries, Inc.
Holly Kramen, PolarityTE
Jill Fallows Macaluso, Novo Nordisk
Lori Queisser, Teva Pharmaceuticals
Moderator: Regina Gore Cavaliere, Esperion Therapeutics, Inc.

5:35 - 7:00

Cocktail Reception sponsored by Gibbons P.C. (Atrium)

8:30 - 9:00

Continental Breakfast

9:00 - 10:05

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

10:05 - 10:25

Break

10:25 - 11:15

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

11:15 - 12:05

Before I Was a Compliance Officer . . .
Jim Sheehan, Office of the New York Attorney General

12:05 - 1:05

Networking Lunch sponsored by Lowenstein Sandler, LLP

1:05 - 2:20

Panel Discussion: Being the Focus of a Government Investigation
Mike Doyle, 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: Jacob Elberg, Seton Hall Law School

2:20 - 2:40

Break

2:40 - 3:45

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

3:45 - 4:00

Concluding Remarks and Award of Certificates