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: ETHICAL ISSUES, PRIVACY, State & Federal Transparency Laws, Federal Health Care Programs & Reimbursement

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)

1:15 - 2:35

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

2:35 - 2:55

Break

2:55 - 4:25

An Overview of Federal Health Care Programs for Drug & Device Manufacturers

Robert Wanerman, Epstein Becker and Green P.C.

4:25 - 5:15

Dealing with Gray Areas & Ethical Issues
Michael McCulley, former Assistant Counsel, Johnson & Johnson

Seton Hall Law School Distinguished Practitioner in Residence

DAY 2: Clinical Trials, Pricing, Anti-Kickback Statute, Foreign Corrupt Practices Act, False Claims Act

8:30 - 9:00

Continental Breakfast (Atrium)

9:00 - 10:00

Compliance Risks Related to Clinical Trials
Suzanne Seferian, Johnson & Johnson

Mark Barnes, Ropes & Gray LLP

10:00 - 11:00

Government Pricing Programs: Key Issues for Compliance Officers
Joseph Metro, Reed Smith 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 - 2:15

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

2:15 - 3:30

The Foreign Corrupt Practices Act
Gary Giampetruzzi, Paul Hastings LLP
Brian Howe, Bristol-Myers Squibb

3:30 - 3:50

Break

3:50 - 5:15

The Perils of Dealing with Whistleblowers under the False Claims Act
Nicholas Harbist, Blank Rome LLP

5:15 - 7:00

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

DAY 3: Advertising & Promotion, drug & Device Approval Process, Professional responsibility, Case Study, Compliance Officers Panel

8:30 - 9:00

Continental Breakfast (Atrium)

9:00 - 10:30

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

10:30 - 10:50

Break

10:50 - 11:50

FDA Regulation of the New Drug Development & Approval Process

Peter Safir, Covington & Burling LLP

11:50 - 12:45

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

12:45 - 1:45

Networking Lunch (Atrium)

1:50 - 2:35

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

Chris Zalesky, Johnson & Johnson

2:35 - 3:35

Compliance Case Study: Break-Out Session and Workshop

3:35 - 3:55

Break

3:55 - 5:00

Compliance Officers Panel Discussion
Jeffrey Klimaski, BTG International
Mary Anne McDonald, formerly of Visiting Nurse Association of Central New Jersey

Mark Petrille, Siemens Healthcare

Bronwen Taylor, Stryker Corporation
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

Industry Compliance Guidance & Codes of Conduct
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




Supporters


ADVAMED