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 13-16, 2022 | Hyflex (In-person + Virtual)

Note: Agenda available below (in Eastern Time).

Day1 Monday, October 11, 2021
 

ETHICS, TRANSPARENCY, PRIVACY, FEDERAL HEALTH CARE PROGRAMS, AND GOVERNMENT PRICING

9:00 a.m.

Registration Opens
 

9:30 – 10:10

Welcome, Program Overview, Introductions
 

Rosa Alves

Rosa Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School
Learn more about Rosa Alves >>

10:15 – 11:10

The Relationship Between Ethics and Legal Compliance

Jacob Elberg

Jacob Elberg
Associate Professor of Law and Associate Director of The Center for Health & Pharmaceutical Law
Learn more about Jacob Elberg >>

11:15 – 12:20

Navigating State, Federal & International Transparency Disclosure Requirements
 

John Oroho

John Oroho
Executive Vice President, Chief Strategy Officer, Porzio Life Sciences, LLC
Learn more about John Oroho >>

John Oroho

Keren Bisnauth
Director of Compliance Services, Porzio Life Sciences, LLC
Learn more about Keren Bisnauth >>

12:20 – 1:25

BREAK

1:25 – 2:40

Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations

 

Anna Spencer

Anna Spencer
Partner, DLA Piper LLP
Learn more about Anna Spencer >>

2:45 – 3:50

An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers

 

Philo D. Hall

Philo D. Hall
Senior Counsel, Epstein Becker & Green, P.C.
Learn more about Philo D. Hall >>

3:50 – 4:05

BREAK
 

11:15 – 12:25

The Federal Anti-Kickback Statute

Marc Larkins

Marc Larkins
Senior Counsel, Johnson & Johnson
Learn more about Marc Larkins >>

Bruce A. Levy

Bruce A. Levy
Director, Commercial & Criminal Litigation, Gibbons P.C.
Learn more about Bruce A. Levy >>

Day2 Tuesday, October 12, 2021
 

FALSE CLAIMS ACT, ANTI-KICKBACK STATUTE, FDA REGULATION, AND FOREIGN CORRUPT PRACTICES ACT

10:00 – 11:10

The False Claims Act and Dealing with Whistleblowers

Meredith Auten

Meredith Auten
Partner, Morgan, Lewis & Bockius LLP
Learn more about Meredith Auten >>

Pamela Coyle Brecht

Pamela Coyle Brecht
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP
Learn more about Pamela Coyle Brecht >>

11:15 – 12:15

Government Pricing Regulation: Key Issues for Compliance Professionals
 

Kathleen A. Peterson

Kathleen A. Peterson
Counsel, Hogan Lovells
Learn more about Kathleen A. Peterson >>

12:25 – 1:30

LUNCH BREAK & Discussion on Health Care Fraud Enforcement in Changing Administrations

Craig Carpenito

Craig Carpenito
Partner, Special Matters & Government Investigations, King & Spaulding
Learn more about Craig Carpenito >>


1:30 – 2:35

Track 1: FDA Regulation of Drug Development & Approval

 

Jennifer D. Oliva

Jennifer D. Oliva
Associate Dean for Faculty Research & Development, Professor of Law, and Director of the Center for Health & Pharmaceutical Law
Learn more about Jennifer D. Oliva >>




Track 2: Overview of U.S. Medical Device Regulation

 

Scott Danzis

Scott Danzis
Partner, Covington & Burling LLP
Learn more about Scott Danzis >>


2:35 – 3:30

A Journey to the Dark Side of International Business: Real-World Risk and Real-World Lessons

 

Richard Bistrong

Richard Bistrong
Front-Line Anti-Bribery LLC; former FCPA Violator & FBI/UK Cooperator
Learn more about Richard Bistrong >>

3:30 – 3:45

BREAK
 

3:50 – 5:00

The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)

 

Gary F. Giampetruzzi

Gary F. Giampetruzzi
Partner, Litigation Department, Paul Hastings LLP
Learn more about Gary F. Giampetruzzi >>

Piyush Sharma

Piyush Sharma
Deputy Chief Compliance Officer, SVP, International Compliance & Global Compliance Operations
Learn more about Piyush Sharma >>

Day3 Wednesday, October 13, 2021
 

ADVERTISING & PROMOTION, PATIENT INTERACTIONS, DATA ANALYTICS, CASE STUDY, AND COMPLIANCE OFFICERS’ PANEL

10:00– 11:05

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
 

Nikki Reeves

Nikki Reeves
Partner, King & Spalding, LLP
Learn more about Nikki Reeves >>

Gillian M. Russell

Gillian M. Russell
Counsel, King & Spalding LLP
Learn more about Gillian M. Russell >>

11:10 – 12:00

Compliance Considerations in the New Age of Patient Advocacy

Liz Lewis

Liz Lewis
Head of Global Oncology Patient Value, Policy & Access, Takeda Oncology
Learn more about Liz Lewis >>

Jacob Elberg

Jacob Elberg
Associate Professor of Law and Associate Director of The Center for Health & Pharmaceutical Law
Learn more about Jacob Elberg >>

12:20 – 1:05

BREAK

1:05 – 2:10

Data Analytics
 

Michael J. Driscoll

Michael J. Driscoll
Director, Global Strategic Insights, Health Care Compliance, Johnson & Johnson
Learn more about Michael J. Driscoll >>

Anna Loveless

Anna Loveless
Manager for Monitoring, Innovation and Infrastructure, Johnson & Johnson
Learn more about Anna Loveless >>

Jacob Elberg

Jacob Elberg
Associate Professor of Law and Associate Director of The Center for Health & Pharmaceutical Law
Learn more about Jacob Elberg >>

2:10 – 2:25

BREAK

2:25 – 3:55

Compliance Case Study Workshop

 

4:00 – 5:10

Compliance Officers Panel Discussion

 

Jill Fallows Macaluso

Jill Fallows Macaluso
Corporate Vice President & Chief Ethics, Compliance & Privacy Officer, Novo Nordisk, Inc.
Learn more about Jill Fallows Macaluso >>

Joe Zimmerman

Joe Zimmerman
VP - Chief Compliance & Privacy Officer, Head of U.S. Government Affairs, Ferring Pharmaceuticals, Inc.
Learn more about Joe Zimmerman >>

Moderator

 

Jacob Elberg

Jacob Elberg
Associate Professor of Law and Associate Director of The Center for Health & Pharmaceutical Law
Learn more about Jacob Elberg >>

5:10 – 6:00

VIRTUAL NETWORKING
 

Day4Thursday, October 14, 2021
 

CORPORATE INTEGRITY AGREEMENTS, INDUSTRY GUIDANCE, HEALTH CARE FRAUD ENFORCEMENT, AND INVESTIGATIONS

10:00– 11:00

Compliance Lessons Learned from Corporate Integrity Agreements
 

Seth H. Lundy

Seth H. Lundy
Partner, King & Spalding LLP
Learn more about Seth H. Lundy >>

11:05 – 12:05

AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals

Jeff Layne

Jeff Layne
Partner, Reed Smith
Learn more about Jeff Layne >>

12:05 – 1:05

BREAK

1:05 – 2:05

Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
 

Rachael A. Honig

Rachael A. Honig
Acting U.S. Attorney for the District of New Jersey
Learn more about Rachael A. Honig >>

2:10 – 3:00

Before I Was a Compliance Officer

 

Jim Sheehan

Jim Sheehan
Chief, Charities Bureau, New York Attorney General’s Office
Learn more about Jim Sheehan >>

3:00 – 3:15

BREAK

3:15 – 4:30

Panel Discussion: Being the Focus of a Government Investigation

 

Laurie Allen

Laurie Allen
Supervisory Special Agent, Federal Bureau of Investigation
Learn more about Laurie Allen >>

Rachael A. Honig

Rachael A. Honig
Acting U.S. Attorney for the District of New Jersey
Learn more about Rachael A. Honig >>

Jim Sheehan

Jim Sheehan
Chief, Charities Bureau, New York Attorney General’s Office
Learn more about Jim Sheehan >>

Moderator

Jacob Elberg

Jacob Elberg
Associate Professor of Law and Associate Director of The Center for Health & Pharmaceutical Law
Learn more about Jacob Elberg >>

4:30 –4:45

CONCLUDING REMARKS
 


Celebrating 15 years in Compliance


Learn more about our programs.