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 October 10-13, 2022 | Virtual
or PROGRAM SCHEDULED for June 12-15, 2023 | In-person

Note: Agenda Available Below - All Times in Eastern Standard Time

Day1 Monday, October 10, 2022
 

Ethics, Transparency, Privacy, Federal Health Care Programs, and Government Pricing 

8:45 a.m.

REGISTRATION OPENS
 

9:00 – 9:45

Welcome, Program Introduction & Format Review

Rosa Alves

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

Jacob Elberg

Jacob Elberg
Associate Professor of Law, Seton Hall Law School
Learn more about Professor Jacob Elberg >>

9:50 – 10:45

The Relationship Between Ethics and Legal Compliance

Jacob Elberg

Jacob Elberg
Associate Professor of Law, Seton Hall Law School
Learn more about Professor Jacob Elberg >>

10:45 – 11:00

BREAK
 

11:00 – 12:15

Navigating State, Federal & International Transparency Disclosure Requirements

Keren Bisnauth

Keren Bisnauth
Associate Vice President, Legal & Regulatory, Porzio Life Sciences, LLC
Learn more about Keren Bisnauth >>

12:15 – 1:00

LUNCH BREAK

1:00 – 2:20

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 >>

2:25 – 3:40

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 >>

3:40 – 4:00

BREAK
 

4:00 – 5:00

Government Pricing Regulation: Key Issues for Compliance Professionals

Kathleen Peterson

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

 

Day2 Tuesday, October 11, 2022
 

False Claims Act, Anti-Kickback Statute, FDA Regulation, Foreign Corrupt Practices Act, and Speaker Programs

8:45 a.m.

REGISTRATION
 

9:00 – 9:55

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

Richard Bistrong

Richard Bistrong
CEO, Front-Line Anti-Bribery LLC
Learn more about Richard Bistrong >>

Jane Yoon

Moderator: Jane Yoon
Partner, Litigation Department, Paul Hastings LLP
Learn more about Jane Yoon >>

10:00 – 11:15

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 – 11:30

BREAK
 

11:30 – 12:45

The Federal Anti-Kickback Statute

Bruce Levy

Bruce Levy
Partner, Hartmann Doherty Rosa Berman & Bulbulia
Learn more about Bruce Levy >>

Freddy Jimenez

Freddy Jimenez
Senior Vice President & General Counsel, Celldex Therapeutics
Learn more about Freddy Jimenez >>

12:45 – 1:45

LUNCH BREAK

1:45 – 3:00

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

Gary Giampetruzzi

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

Nicole Stovall

Nicole Stovall
Head of Global Investigations, Office of General Counsel, Merck & Co.
Learn more about Nicole Stovall >>

3:05 – 3:50

Compliance Risks Associated with Speaker Programs

Craig Carpenito

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

Amy Boring

Amy Boring
Partner, Special Matters & Government Investigations, King & Spalding LLP
Learn more about Amy Boring >>

3:50 – 4:05

BREAK
 

4:05 – 5:10

Track 1: FDA Regulation of Drug Development & Approval

Julia Post

Julia Post
Of Counsel, Covington & Burling LLP
Learn more about Julia Post >>




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

Scott Danzis

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


5:15 – 6:00

VIRTUAL NETWORKING RECEPTION
 

Day3 Wednesday, October 12, 2022
 

Advertising & Promotion, Data Analytics, Corporate Integrity Agreements, Case Study, and Compliance Officers' Panel

8:45 a.m.

REGISTRATION
 

9:00– 10:05

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 >>

10:05 – 10:20

BREAK

10:20 – 11:35

Data Analytics

Michael Driscoll

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

Jacob Elberg

Jacob Elberg
Associate Professor of Law, Seton Hall Law School
Learn more about Professor Jacob Elberg >>

Anna Loveless

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

11:40 – 12:40

Compliance Lessons Learned from Corporate Integrity Agreements

Seth Lundy

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

12:40 – 1:40

LUNCH BREAK

1:40 – 3:40

Compliance Case Study Workshop: Break-Out Session & Workshop

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
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
Learn more about Joe Zimmerman >>

Margaret Sparks

Margaret Sparks
Head of Compliance, Vaccines (U.S.) North America Ethics and Business Integrity, Sanofi
Learn more about Margaret Sparks >>

Jennifer McGee

Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals
Learn more about Jennifer McGee >>

Regina Gore Cavaliere

Regina Gore Cavaliere
Vice President, Regulatory and Compliance, Chief Ethics and Compliance Officer, Henry Schein, Inc.
Learn more about Regina Gore Cavaliere >>

3:40 – 3:55

BREAK

3:55 – 5:15

Compliance Officers Panel Discussion

Margaret Sparks

Margaret Sparks
Head of Compliance, Vaccines (U.S.) North America Ethics and Business Integrity, Sanofi
Learn more about Margaret Sparks >>

Jennifer McGee

Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals
Learn more about Jennifer McGee >>

Regina Gore Cavaliere

Regina Gore Cavaliere
Vice President, Regulatory and Compliance, Chief Ethics and Compliance Officer, Henry Schein, Inc.
Learn more about Regina Gore Cavaliere >>

Michael (Mickey) Kim

Michael (Mickey) Kim
Global Chief Compliance Officer, Pentax Medical
Learn more about Michael (Mickey) Kim >>

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
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
Learn more about Joe Zimmerman >>

Dean Boozang

Moderator: Kathleen Boozang
Dean, Seton Hall Law School
Learn more about Dean Kathleen Boozang >>

Day4 Thursday, October 13, 2022
 

Patient Interactions, Industry Guidance, Health Care Fraud Enforcement, and Investigations

8:45 a.m.

REGISTRATION
 

9:00– 10:00

Diversity, Equity and Inclusion in the Compliance Industry
 

Javier Robles

Javier Robles
Assistant General Counsel, FIS
Learn more about Javier Robles >>

10:00 – 10:25

BREAK

10:25 – 11:25

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

Katie Pawlitz

Katie Pawlitz
Partner, Reed Smith LLP
Learn more about Katie Pawlitz >>

11:30 – 12:30

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

Lee Cortes

Lee Cortes
Executive Assistant United States Attorney, U.S. Attorney's Office, District of New Jersey
Learn more about Lee Cortes >>

12:30 – 1:30

LUNCH BREAK

1:30 – 2:20

Before I Was a Compliance Officer ...

Jim Sheehan

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

2:25 – 3:45

Panel Discussion: Being the Focus of a Government Investigation

Lee Cortes

Lee Cortes
Executive Assistant United States Attorney, U.S. Attorney's Office, District of New Jersey
Learn more about Lee Cortes >>

Laurie Allen

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

Jane Yoon

Jane Yoon
Partner, Litigation Department, Paul Hastings LLP
Learn more about Jane Yoon >>

Jim Sheehan

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

John Kelly

John Kelly
Partner, Healthcare Department and Healthcare Industry Practice Chair, Barnes & Thornburg LLP
Learn more about John Kelly >>

Jacob Elberg

Moderator: Jacob Elberg
Associate Professor of Law, Seton Hall Law School
Learn more about Professor Jacob Elberg >>

3:45

CONCLUDING REMARKS