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Healthcare Compliance Training - Program Schedule


 

 

U.S. Healthcare Compliance Certificate Program

[email protected] | 973-642-8871 or 973-761-9000 ext. 8871

PROGRAM SCHEDULED for June 10-13, 2019  | 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

Program Opens; Continental Breakfast

9:00 - 9:30

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

9:30 - 10:20

The Relationship Between Ethics and Legal Compliance
Professor Timothy P. Glynn, Senior Associate Dean, Seton Hall Law School

10:20 - 10:40

Break

10:40 - 11:50

Navigating State, Federal & International Transparency Disclosure Requirements
Brian Sharkey, Porzio Life Sciences, LLC
Keren Bisnauth, Porzio Life Sciences, LLC

11:50 - 12:50

Networking Lunch

12:50 - 2:20

Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Libbie Canter, Covington & Burling LLP

2:20 - 2:35

Break

2:35 - 3:55

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

3:55 - 4:15

Break

4:15 - 5:15

Government Pricing Regulation: Key Issues for Compliance Professionals
Kathleen Peterson, Hogan Lovells

DAY 2

8:30 - 9:00

Continental Breakfast sponsored by Drinker Biddle & Reath LLP

9:00 - 10:15

Choose a Track:

Track 1: FDA Regulation of Drug Development & Approval
Michael Stern, Covington & Burling LLP

Track 2: FDA Regulation of Medical Devices
Christopher Hanson, Covington & Burling LLP

10:15 - 10:35

Break

10:35 - 12:00

Data Analytics
Michael Driscoll, Johnson & Johnson
Jacob Elberg, Seton Hall Law School
Anna Loveless, Johnson & Johnson

12:00 - 1:00

Networking Lunch sponsored by Paul Hastings LLP

1:00 - 2:00

A Journey to the Dark Side of International Business: Real-World Risk and Real-World Lessons
Richard Bistrong, CEO, Front-Line Anti-Bribery LLC; former FCPA Violator & FBI/UK Cooperator

2:00 - 3:15

The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
Gary Giampetruzzi, Paul Hastings LLP
Piyush Sharma, Alexion Pharmaceuticals, Inc.

3:15 - 3:30

Break

3:30 - 4:30

The Perils of Dealing with Whistleblowers Under the False Claims Act
Lynne Anne Anderson, Drinker Biddle & Reath LLP
Jesse Witten, Drinker Biddle & Reath LLP

4:30 - 5:45

The Federal Anti-Kickback Statute
Bruce Levy, Gibbons P.C.

5:45 - 7:00

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

DAY 3

8:30 - 9:00

Continental Breakfast

9:00 - 10:15

Compliance Considerations in the New Age of Patient Advocacy
Patrik Florencio, Amicus Therapeutics
Jayne Gershkowitz, Amicus Therapeutics
Ellen Rosenberg, Amicus Therapeutics

10:15 - 10:35

Break

10:35 - 12:20

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Elizabeth Kim, Loeb & Loeb LLP

12:20 - 1:20

Networking Lunch

1:20 - 2:10

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

2:10 - 3:25

Compliance Case Study: Break-Out Session & Workshop

3:25 - 3:45

Break

3:45 - 5:00

Compliance Officers Panel Discussion
Charlene Davis, Sun Pharmaceutical Industries, Inc.
Jill Fallows-Macaluso, Novo Nordisk
Holly Kramen, PolarityTE
Joseph Zimmerman, Ferring Pharmaceuticals Inc.
Moderator: Regina Gore Cavaliere, KPMG LLP

DAY 4

8:30 - 9:00

Continental Breakfast

9:00 - 9:50

Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
Rachael Honig, U.S. 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
Mike Doyle, Federal Bureau of Investigation
Rachael Honig, U.S. Attorney’s Office, District of New Jersey
Jenny Kramer, Alston & Bird
Scott McBride, Lowenstein Sandler P.C.
Jim Sheehan, New York Attorney General’s Office
Moderator: Jacob Elberg, Seton Hall Law School

12:15 - 1:15

Networking Lunch sponsored by Lowenstein Sandler, LLP

1:15 - 2:20

Health Care Fraud Sentencing, Penalties, Damages & Other Considerations
Scott McBride, Lowenstein Sandler, LLP
Jenny Kramer, Alston & Bird
Joseph Mack, Bayer U.S.

2:20 - 2:40

Break

2:40 - 3:45

AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Katie Pawlitz, Reed Smith LLP

3:45 - 4:00

Concluding Remarks and Award of Certificates

 


SILVER SPONSORS

Gibbons

Lowenstein Sandler

Paul Hastings

BRONZE SPONSOR


DrinkerBiddle

SUPPORTING SPONSORS

ADVAMED MDMA