Program Schedule


 

U.S. Healthcare Compliance Certification Program

PROGRAM SCHEDULED for June 8-11, 2015 | Newark, New Jersey


This schedule is subject to change and will be provided on the first day of the Program.
DAY 1

8:30 - 9:00

Registration Opens/Continental Breakfast (Atrium)

9:00 - 9:30

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

9:30 - 10:20

Business Ethics and Legal Compliance
Professor Timothy Glynn, Seton Hall Law School

10:20 - 10:40

Break

10:40 - 11:55

How to Create a Culture of Compliance
Dan Garen, Danaher

 

11:30 - 1:00

 

Privacy and Data Protection: Pharmaceutical and Biotech Industry Privacy Considerations

Anna Spencer, Sidley Austin LLP

1:00 - 2:00

Networking Lunch (Atrium)

2:00 - 3:30

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

3:30 - 3:45

Break

3:45 - 4:45

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

4:45 - 5:30

Health Care Compliance in the Clinical Research Context
Sue Seferian, Johnson & Johnson

Mark Barnes, Ropes & Gray

DAY 2

8:30 - 9:00

Continental Breakfast (Atrium)

9:00 - 10:00

FDA Regulation of the New Drug Development & Approval Process
Professor Jordan Paradise, Seton Hall Law School

10:00 - 11:00

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

11:00 - 11:20

Break

11:20 - 12:20

The Federal Anti-Kickback Statute
Mike Bell, R-Squared
Bruce Levy, Gibbons PC

12:20 - 1:20

Networking Lunch (Atrium)

1:25 - 1:40

Re-cap Hypo

1:40 - 2:30

The Federal Anti-Kickback Statute (continued)
Mike Bell, R-Squared
Bruce Levy, Gibbons PC

2:30 - 3:45

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

3:45 - 4:05

Break

4:05 - 5:30

The False Claims Act - Three Tactics
Nicolas Harbist, Blank Rome

5:30 - 7:00

Cocktail Reception

DAY 3

8:30 - 9:00

Continental Breakfast (Atrium)

9:00 - 10:30

Prescription Drug & Medical Device Advertising/Scientific and Educational Activities
Howard Dorfman, Turing Pharmaceuticals

10:30 - 10:50

Break

10:50 - 12:20

Understanding Federal and State Reporting Laws from All Corners

John Oroho, Porzio Bromberg & Newman P.C.

Sandra Gonzalez, Porzio Bromberg & Newman P.C.

12:20 - 1:20

Networking Lunch (Atrium)

1:20 - 1:40

Re-cap Hypo

1:40 - 2:30 

Maintaining Professional Competence: Emerging Standards of Professional Responsibility for Health Care Compliance Professionals in the Pharmaceutical, Biotech & Medical Device Industries
Chris Zalesky, Johnson & Johnson

2:30 - 3:30

Compliance Case Study: Break-Out Session and Workshop

3:30 - 3:50

Break

3:50 - 5:15

Compliance Officers Panel Discussion
Michael Clarke, Actavis
Karen Lowney, Astellas
Mark Petrille, Siemens Healthcare
Bronwen Taylor, Stryker
Moderator: Professor Timothy Glynn, Seton Hall Law School

DAY 4

8:30 - 9:00

Continental Breakfast (Atrium)

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
Lynne Anne Anderson, Drinker Biddle & Reath LLP

Mike Doyle, Federal Bureau of Investigation

Jacob Elberg, U.S. Attorney's Office, District of New Jersey
Maureen Ruane, Lowenstein Sandler P.C.
Jim Sheehan, Office of the New York Attorney General
Moderator: Professor Timothy Glynn, Seton Hall Law School

12:15 - 1:15

Networking Lunch (Atrium)

1:20 - 2:20

Health Care Fraud Sentencing, Penalties, Damages & Other Considerations
Maureen Ruane, Lowenstein Sandler P.C.

2:20 - 2:40

Break

2:40 - 3:40

AdvaMed v. PhRMA
Elizabeth Carder-Thompson, Reed Smith LLP

3:40 - 4:00

Concluding Remarks and Award of Certificates