Healthcare Compliance Training - Program Schedule


 

 

U.S. Healthcare Compliance Certification Program

healthlaw@shu.edu | 973-642-8871

PROGRAM SCHEDULED for October 9-12, 2017  | 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

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

Privacy and Data Protection: Pharmaceutical and Biotech Industry Privacy Considerations
Libbie Canter, Covington & Burling LLP
Co-presenter TBA

12:10 - 1:10

Networking Lunch sponsored by Biomarin

1:10 - 2:45

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

2:45 - 3:00

Break

3:00 - 4:10

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

4:10 - 5:15

AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Elizabeth Carder-Thompson, Reed Smith LLP

DAY 2

8:30 - 9:00

Continental Breakfast

9:00 - 10:00

FDA Regulation of the New Drug Development & Approval Process
Denise Esposito, Covington & Burling LLP

10:00 - 11:00

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

11:00 - 11:15

Break

11:15 - 12:15

The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
S. Joy Dowdle, Paul Hastings LLP
Sujata Dayal, Johnson & Johnson

12:15 - 12:45

A Journey to the Dark Side of Business: Lessons from Real-World Risk
S. Joy Dowdle, Paul Hastings LLP
Richard Bistrong, Former FCPA Violator and FBI/UK Cooperator

12:45 - 1:45

Networking Lunch sponsored by Paul Hastings LLP

1:45 - 2:15

Keynote Address
Paul Fishman, Former U.S. Attorney for the District of New Jersey

2:15 - 3:25

“Lyin, Cheatin, Stealin?” The Perils of Dealing with Whistleblowers Under the False Claims Act
Nicholas Harbist, Blank Rome LLP

3:25 - 4:25

The Federal Anti-Kickback Statute
Bruce Levy, Gibbons P.C.
Marc Larkins, Johnson & Johnson

4:25 - 4:40

Break

4:40 - 5:30

The Fedearl Anti-Kickback Statute (con't)
Bruce Levy, Gibbons P.C.
Marc Larkins, Johnson & Johnson

5:30 - 7:00

Cocktail Reception sponsored by Gibbons P.C. (Atrium)

DAY 3 - sponsored by kpmg

8:30 - 9:00

Continental Breakfast

9:00 - 9:50

Healthcare Compliance in the R&D Context - Focus on CROs & Research
Sue Seferian, Johnson & Johnson
Yolanda Lyle, Pfizer

9:50 - 10:50

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

10:50 - 11:05

Break

11:05 - 11:50

#SocialMedia
Elizabeth Kim, Loeb & Loeb LLP

11:50 - 1:20

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

1:20 - 2:20

Networking Lunch sponsored by KPMG

2:20 - 3:15

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

3:15 - 4:15

Compliance Case Study: Break-Out Session & Workshop

4:15 - 4:30

Break

4:30 - 5:30

Compliance Officers Panel Discussion
Michael Clarke, Indivior
Charlene Davis, Sun Pharmaceutical Industries
Jill Fallows-Macaluso, Novo Nordisk
Brian O’Reilly, Dentsply Sirona
Moderator: Regina Cavaliere, KPMG

DAY 4

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
Lynne Anne Anderson, Drinker Biddle & Reath LLP
Mike Doyle, Federal Bureau of Investigation
Jacob Elberg, U.S. Attorney's Office, District of New Jersey
Scott McBride, Lowenstein Sandler P.C.
Jim Sheehan, Office of the New York Attorney General
Moderator: Senior Associate Dean Timothy Glynn, Seton Hall Law School

12:15 - 1:15

Networking Lunch sponsored by Lowenstein Sandler, LLP

1:20 - 2:20

Health Care Fraud Sentencing, Penalties, Damages & Other Considerations
Scott McBride, Lowenstein Sandler, LLP
Jenny Kramer, Chadbourne & Parke

2:20 - 2:40

Break

2:40 - 3:40

How to Create a Culture of Compliance
Carlos Tessi, Shionogi Inc.

3:40 - 4:00

Concluding Remarks and Award of Certificates

 




CCB Credits (29.5)


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