8:30 - 9:00

Registration Opens

9:00 - 9:30

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

9:30 - 10:20

Business Ethics and Legal Compliance
Professor Timothy P. Glynn, Senior Associate Dean, Seton Hall Law School

10:20 - 10:40

Break

10:40 - 12:10

Topics in Privacy and Data Protection: Pharmaceutical and Biotech Industry Privacy Considerations
George Breen, Epstein Becker & Green, P.C.
Patricia Wagner, Epstein Becker & Green, P.C.

12:10 - 1:10

Networking Lunch

1:10 - 2:30

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

2:30 - 3:30

Government Pricing Regulation: Key Issues for Compliance Professionals
Joseph Metro, Reed Smith LLP

3:30 - 3:50

Break

3:50 - 5:00

Navigating State, Federal & International Transparency Disclosure Requirements
John Oroho, Porzio Bromberg & Newman P.C.
Keren Bisnauth, Porzio Life Sciences, LLC

8:30 - 9:00

Continental Breakfast

9:00 - 10:15

FDA Regulation of Drug Development & Approval
Scott Cunningham, Covington & Burling LLP

10:15 - 10:35

Break

10:35 - 11:35

FDA Regulation of Medical Devices
Christopher Hanson, Covington & Burling LLP

11:35 - 12:20

Culture, Ethics & Compliance
Carlos Tessi, Shionogi, Inc.

12:20 - 1:20

Networking Lunch sponsored by Paul Hastings LLP

1:20 - 2:50

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

2:50 - 3:50

The Perils of Dealing with Whistleblowers Under the False Claims Act
Jesse Witten, Drinker Biddle & Reath LLP
Lawrence Del Rossi, Drinker Biddle & Reath LLP

3:50 - 4:10

Break

4:10 - 5:45

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

5:45 - 7:00

Cocktail Reception (Atrium)

8:30 - 9:00

Continental Breakfast

9:00 - 10:15

Industry Interactions with Patients: What is Possible and Appropriate?
Ellen Coleman, MSSA, MPH, MK&A
Tim Turnham, Phd, MK&A

10:15 - 10:35

Break

10:35 - 11:35

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Howard Dorfman, H.L. Dorfman Pharmaceutical Consulting

11:35 - 12:35

#SocialMedia
Elizabeth Kim, Loeb & Loeb LLP

12:35 - 1:35

Networking Lunch

1:35 - 2:25

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

2:25 - 3:40

Compliance Case Study: Break-Out Session & Workshop

3:40 - 4:00

Break

4:00 - 5:15

Compliance Officers Panel Discussion
Jill Fallows-Macaluso, Novo Nordisk
Holly Kramen, PolarityTE
Joseph Zimmerman, Ferring Pharmaceuticals Inc.
Moderator: Regina Gore Cavaliere, KPMG LLP

8:30 - 9:00

Continental Breakfast

9:00 - 9:50

Recent Developments in Federal Health Care Fraud Enforcement & The Value of Compliance and Cooperation
Jacob Elberg, US Attorney's Office, District of New Jersey

9:50 - 10:40

Before I Was a Compliance Officer - Notes of a Recovering Prosecutor
Jim Sheehan, Office of the New York Attorney General

10:40 - 11:00

Break

11:00 - 12:15

Panel Discussion: Being the Focus of a Government Investigation
Mike Doyle, Federal Bureau of Investigation
Jacob Elberg, 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: Professor Timothy Glynn, Seton Hall Law School

12:15 - 1:15

Networking Lunch sponsored by Lowenstein Sandler, LLP

1:15 - 2:20

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

2:20 - 2:40

Break

2:40 - 3:45

AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Katie Pawlitz, Reed Smith LLP

3:45 - 4:00

Concluding Remarks and Award of Certificates