Healthcare Compliance Training - Program Schedule


 

U.S. Healthcare Compliance Certification Program

PROGRAM SCHEDULED for October 12-15, 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 - 12:10

Privacy and Data Protection: Pharmaceutical and Biotech Industry Privacy Considerations
Anna Spencer, Sidley Austin LLP

12:10 - 1:10

Networking Lunch (Atrium)

1:10 - 2:30

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

2:30 - 2:50

Break

2:50 - 3:50

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

3:50 - 4:50

Health Care Compliance in the Clinical Research Context
Sue Seferian, Johnson & Johnson
Dennis Barnes, PAREXEL International

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 sponsored by Paul Hastings LLP (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
Co-presenter TBD

3:45 - 4:05

Break

4:05 - 5:30

The False Claims Act - Three Tactics
Marc Raspanti, Pietragallo Gordon Alfano Bosick & Raspanti

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.

12:30 - 12:35

Re-cap Hypo

12:35 - 1:35

Networking Lunch (Atrium)

1:35 - 2:25 

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

2:25 - 3:15

How to Create a Culture of Compliance
Dan Garen, Danaher

3:15 - 4:00

Compliance Case Study: Break-Out Session and Workshop

4:00 - 4:20

Break

4:20 - 5:30

Compliance Officers Panel Discussion
Dan Garen, Danaher
Karen Lowney, Astellas
Chris Zalesky, Johnson & Johnson
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 sponsored by Lowenstein Sandler P.C. (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








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