Healthcare Compliance Training - Program Schedule




U.S. Healthcare Compliance Certificate Program

[email protected] | 973-642-8382 or 973-761-9000 ext. 8382


PROGRAM SCHEDULED for June 12-15, 2023 | In-person
or PROGRAM SCHEDULED for October 9-12, 2023 | Virtual

Note: Agenda Below - All Times in Eastern Standard Time

Day1 - MOnday, june 12, 2023
 

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

8:30 – 9:00 a.m.

REGISTRATION & BREAKFAST
 

9:00 – 9:20

Welcome, Program Introduction & Format Review

Rosa Alves

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

Jacob Elberg

Jacob T. Elberg
Associate Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Learn more about Jacob T. Elberg

9:25 – 10:15

The Relationship Between Ethics and Legal Compliance

Jacob Elberg

Jacob T. Elberg
Associate Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Learn more about Professor Jacob Elberg 

10:15 – 10:35

BREAK
 

10:35 – 12:00

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

12:00 – 1:00

LUNCH BREAK

1:00 – 2:30

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

2:35 – 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, june 13, 2023
 

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

8:30 – 9:00  a.m.

REGISTRATION & BREAKFAST
 

9:00 – 10:15

The False Claims Act and Dealing with Whistleblowers

Meredith Auten

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

Gregg Shapiro

Gregg Shapiro
Principal, Gregg Shapiro Law, LLC
Learn more about Gregg Shapiro

10:15 – 10:30

BREAK
 

10:30 – 11:45

The Federal Anti-Kickback Statute

Bruce Levy

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

Freddy Jimenez

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

11:45 – 12:45

LUNCH BREAK

12:45 – 1:55

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


2:00 – 3:20

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

3:25 – 3:40

BREAK

3:40 – 4:25

Compliance Risks Associated with Speaker Programs

Craig Carpenito

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

Adam Baker

Adam Baker
Partner, Special Matters & Government Investigations, King & Spalding LLP
Learn more about Adam Baker

4:30 – 5:15

Compliance Case Study Workshop: Break-Out Sessions


5:15 – 6:15

COCKTAIL RECEPTION - CAFÈ DENI
 

Day3 - wednesday, june 14, 2023
 

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

8:30 – 9:00 a.m.

REGISTRATION & BREAKFAST
 

9:00 – 10:30

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities

Gillian M. Russell

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

10:30 – 10:50

BREAK

10:20 – 11:35

Data Analytics

Stacy Aiken

Stacy Aiken
Director for Global Assessments and Consulting Services, Health Care Compliance (HCC), Johnson & Johnson
Learn more about Stacy Aiken

Jacob Elberg

Jacob T. Elberg
Associate Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Learn more about Jacob T. Elberg

12:05 – 1:05

LUNCH BREAK

1:05 – 2:05

Compliance Lessons Learned from Corporate Integrity Agreements

Seth Lundy

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

Brian Bohnenkamp

Brian Bohnenkamp
Partner, King & Spalding LLP
Learn more about Brian Bohnenkamp

2:10 – 3:20

Compliance Case Study Workshop: Break-Out Session & Workshop

Joe Zimmerman

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

Margaret Sparks

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

Christie Camelio

Christie Camelio
Senior Vice President, Chief Compliance & Risk Officer, EQRx
Learn more about Christie Camelio

3:20 – 3:40

BREAK

3:40 – 5:00

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

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

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

Christie Camelio

Christie Camelio
Senior Vice President, Chief Compliance & Risk Officer, EQRx
Learn more about Christie Camelio

Jacob Elberg

Moderator: Jacob T. Elberg
Associate Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Learn more about Jacob T. Elberg

Day4 - thursday, june 15, 2023
 

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

8:30 – 9:00 a.m.

REGISTRATION & BREAKFAST
 

9:00 – 10:20

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

Jeff Layne

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

10:20 – 10:35

BREAK

10:35 – 11:35

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

11:45 – 12:45

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

Vikas Khanna

Vikas Khanna
First Assistant U.S. Attorney, U.S. Attorney’s Office, District of New Jersey
Learn more about Vikas Khanna

12:45 – 1:45

LUNCH BREAK

1:45 – 2:35

Before I Was a Compliance Officer ...

Jim Sheehan

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

2:40 – 4:00

Panel Discussion: Being the Focus of a Government Investigation

Vikas Khanna

Vikas Khanna
First Assistant U.S. Attorney, U.S. Attorney’s Office, District of New Jersey
Learn more about Vikas Khanna

Jane Yoon

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

John Kelly

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

Jim Sheehan

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

Jacob Elberg

Moderator: Jacob Elberg
Associate Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Learn more about Jacob T. Elberg

4:00 - 4:15

CONCLUDING REMARKS