Program Schedule

U.S. Healthcare Compliance Certification Program

PROGRAM SCHEDULED for October 13-16, 2014 | Newark, New Jersey


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


DAY 1: ETHICS, A culture of compliance, Federal Health Care Programs, government pricing, and privacy

8:30 - 9:00

Registration Opens/Continental Breakfast (Atrium)

9:00 - 9:40

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

9:40 - 10:30

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

10:30 - 10:55

Break

10:55 - 11:55

How to Create a Culture of Compliance
Melissa LaFrain, Wright Medical

11:55 - 12:55

Networking Lunch (Atrium)

1:00 - 2:30

An Overview of Federal Health Care Programs for Drug and Device Manufacturers
Robert Wanerman, 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 - 5:20

Privacy and Data Protection: Pharmaceutical and Biotech Industry Privacy Considerations
Meenakshi Datta, Sidley Austin LLP

DAY 2: FDA REGULATION, ANTI-KICKBACK STATUTE, FOREIGN CORRUPT PRACTICES ACT, FALSE CLAIMS ACT

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
J Carson Pulley, Pfizer

3:45 - 4:05

Break

4:05 - 5:30

The Perils of Dealing with Whistleblowers under the False Claims Act
Chris Hall, Saul Ewing

5:30 - 7:00

Cocktail Reception Sponsored by Gibbons PC & R-Squared (Atrium)

DAY 3: CLINICAL RESEARCH, DRUG AND DEVICE ADVERTISING, FEDERAL AND STATE REPORTING, PROFESSIONAL RESPONSIBILITY, CASE STUDY, COMPLIANCE OFFICERS PANEL

8:30 - 9:00

Continental Breakfast (Atrium)

9:00 - 9:45

Health Care Compliance in the Clinical Research Context
Dennis Barnes, PAREXEL International

9:45 - 11:15

Prescription Drug & Medical Device Advertising/Scientific and Educational Activities
Howard Dorfman, Ferring Pharmaceuticals, Inc.

11:15 - 11:35

Break

11:35 - 12:55

Understanding Federal and State Reporting Laws from All Corners
John Oroho, Porzio Bromberg & Newman P.C.
Sandra González, Porzio Bromberg & Newman P.C.

12:55 - 1:55

Networking Lunch (Atrium)

2:00 - 2:15

Re-cap Hypo

2:15 - 3:05  

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

3:05 - 4:05

Compliance Case Study: Break-Out Session and Workshop

4:05 - 4:20

Break

4:20 - 5:30

Compliance Officers Panel Discussion
Michael Clarke, Actavis
Eve Costopoulos, Eisai
Mark Petrille, Siemens Healthcare
Chris Zalesky, Johnson & Johnson
Moderator: Professor Timothy Glynn, Seton Hall Law School

DAY 4: Healthcare Fraud Enforcement, Investigations, Penalties, Industry Guidance

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

12:15 - 1:15

Networking Lunch (Atrium)

1:20 - 2:20

AdvaMed v. PhRMA: Comparing Codes of Ethics
Elizabeth Carder-Thompson, Reed Smith LLP

2:20 - 2:40

Break

2:40 - 3:40

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

3:40 - 4:00

Concluding Remarks and Award of Certificates





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