U.S. Healthcare Compliance Certificate Program

Healthcare Compliance Training - United States Program

U.S. Healthcare Compliance Certificate Program

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


PROGRAM SCHEDULED for October 7-10, 2024 | Virtual
or PROGRAM SCHEDULED for June 2-5, 2025 | In-Person

Agenda Below - All Times in Eastern Standard Time

Day 1 - Monday, October 7, 2024

 

Ethics; Transparency; Federal Health Care Programs; Government Pricing; and FDA Regulation

8:45 - 9:00am 

Registration

9:00 - 9:20am

Welcome, Program & Format Review
Rosa Alves

Rosa M. Alves

Assistant Dean for Global Compliance & Programming, Seton Hall Law School

Learn more about Rosa M. Alves

Jacob Elberg

Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School

Learn more about Jacob T. Elberg 

9:20 - 10:00

Introductions & Icebreaker
Rosa Alves

Rosa M. Alves

Assistant Dean for Global Compliance & Programming, Seton Hall Law School

Learn more about Rosa M. Alves

Jacob Elberg

Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School

Learn more about Jacob T. Elberg 

10:05 - 10:55

The Relationship Between Ethics and Legal Compliance
Jacob Elberg

Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School

Learn more about Jacob T. Elberg 

10:55 - 11:10

Break

11:10 - 12:30

Navigating Global Transparency Disclosure Requirements
Keren F. Bisnauth

Keren F. Bisnauth

Associate Vice President, Legal & Regulatory, Porzio Life Sciences, LLC (an RLDatix Company)

Learn more about Keren F. Bisnauth

12:30 - 1:30

Lunch Break

1:30 - 2:40

An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers
Philo D. Hall

Philo D. Hall

Member of the Firm, Epstein Becker & Green, P.C.

Learn more about Philo D. Hall

2:45 - 3:50

Government Pricing Regulation: Key Issues for Compliance Professionals
Kathleen Peterson

Kathleen Peterson

Counsel, Global Regulatory, Hogan Lovells

Learn more about Kathleen Peterson

3:50 - 4:05

Break

4:05 - 5:15

Track 1: FDA Regulation of Drug Development & Approval 
Julia Post

Julia Post

Of Counsel, Covington & Burling

Learn more about Julia Post

4:05 - 5:15

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

Scott Danzis

Partner, Covington & Burling LLP

Learn more about Scott Danzis

 

Day 2 - Tuesday, October 8, 2024

 

False Claims Act; Codes of Ethics; Foreign Corrupt Practices Act; Diversity, Equity and Inclusion; Advertising & Promotion; and Speaker Programs 

8:45 - 9:00

Registration

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

Pamela Coyle Brecht

Pamela Coyle Brecht

Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP

Learn more about Pamela Coyle Brecht

10:15 - 10:30

Break

10:30 - 11:45

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

Katie C. Pawlitz

Partner, Reed Smith LLP

Learn more about Katie C. Pawlitz

11:45 - 12:45

Lunch Break

12:45 - 2:05

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

Gary Giampetruzzi

Partner, Litigation Department, Paul Hastings

Learn more about Gary Giampetruzzi

Stephen Chien

Stephen Chien

Vice President, Global Compliance Lead, Gilead Sciences, Inc. 

Learn more about Stephen Chien

2:10 - 3:00

Diversity, Equity and Inclusion in the Compliance Industry
Sunita Patel

Sunita Patel

Counsel, Bristol Myers Squibb

Learn more about Sunita Patel

Sapna Palla

Sapna Palla

Partner, A&O Shearman

Learn more about Sapna Palla

Jacob T. Elberg

Moderator: Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School

Learn more about Jacob T. Elberg

3:00 - 3:15

Break

3:15 - 4:40

Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Gillian M. Russell

Gillian M. Russell

Counsel, FDA & Life Sciences, King & Spalding LLP

Learn more about Gillian M. Russell

Nikki Reeves

Nikki Reeves

Partner, FDA & Life Sciences, King & Spalding LLP

Learn more about Nikki Reeves

4:45 - 5:30

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

5:30 - 6:30

Oprional Virtual Networking Reception

 

Day 3 - Wednesday, October 9, 2024

 

Corporate Integrity Agreements; Anti-Kickback Statute; Case Study; and Compliance Officers’ Panel

8:45 - 9:00

Registration

9:00 - 10:00

Compliance Lessons Learned from Corporate Integrity Agreements
Seth Lundy

Seth Lundy

Partner, FDA and Life Sciences, King & Spalding LLP

Learn more about Seth Lundy

10:00 - 10:15

Break

10:15 - 11:20

The Federal Anti-Kickback Statute 
Bruce Levy

Bruce Levy

Partner, Hartmann Doherty Rosa Berman & Bulbulia

Learn more about Bruce Levy

11:20 - 12:45

Compliance Case Study Workshop: Break-Out Sessions 

12:45 - 1:45

Lunch Break

1:45 - 3:00

Compliance Officers Panel Discussion
Joseph Zimmerman

Joseph Zimmerman

Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.

Learn more about Joseph Zimmerman

Christie Camelio

Christie Camelio

Sr. VP, Chief Compliance Officer, Insmed

Learn more about Christie Camelio

Jennifer McGee

Jennifer McGee

Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.

Learn more about Jennifer McGee

Jill Fallows Macaluso

Jill Fallows Macaluso

Corp. VP & North America Chief Ethics & Compliance Officer, Novo Nordisk

Learn more about Jill Fallows Macaluso

Margaret Sparks

Margaret Sparks

Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi

Learn more about Margaret Sparks

Jacob T. Elberg

Moderator: Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School

Learn more about Jacob T. Elberg 

3:00 - 3:15

Break

3:15 - 4:45

Compliance Case Study Workshop: Break-Out Sessions & Workshop
Joseph 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 Officer, Insmed

Learn more about Christie Camelio

Jennifer McGee

Jennifer McGee

Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.

Learn more about Jennifer McGee

Jill Fallows Macaluso

Jill Fallows Macaluso

Corp. VP & North America Chief Ethics & Compliance Officer, Novo Nordisk

Learn more about Jill Fallows Macaluso

Margaret Sparks

Margaret Sparks

Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi

Learn more about Margaret Sparks

 

Day 4 - Thursday, October 10, 2024

 

Privacy, Data Analytics, and Health Care Fraud Enforcement, and Investigations

8:45 - 9:00

Registration

9:00 - 10:15

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

Jeremy Berkowitz

Senior Privacy Director & Deputy Chief Privacy Officer, Paul Hastings, LLP

Learn more about Jeremy Berkowitz

10:15 - 10:30

Break

10:30 - 11:30

Data Analytics
Anna Loveless

Anna Loveless 

Associate Director, Advanced Solutions within the Global Development Organization, Johnson & Johnson Innovative Medicine

Learn more about Anna Loveless

Michael Driscoll

Michael Driscoll

Managing Member, Driscoll & DeSimone, LLC & Former, Director, Global Strategic Insights, Health Care Compliance, Johnson & Johnson 

Learn more about Michael Driscoll

Jacob T. Elberg

Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School

Learn more about Jacob T. Elberg

11:35 - 12:30

Before I Was a Compliance Officer … 
James Sheehan

James Sheehan

Chief, Charities Bureau, New York Attorney General’s Office

Learn more about James Sheehan

12:30 - 1:30

Lunch Break

1:30 - 2:35

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 H. Yoon

Jane H. Yoon

Partner, Litigation Department, Paul Hastings LLP

Learn more about Jane H. Yoon

John Kelly

John Kelly

Partner & Chair of the Healthcare Department and Industry Practice, Barnes & Thornburg LLP

Learn more about John Kelly 

James Sheehan

James Sheehan

Chief, Charities Bureau, New York Attorney General’s Office

Learn more about James Sheehan

Katie Holden

Katie Holden

Federal Bureau of Investigations, Newark Field Office

Jacob T. Elberg

Moderator: Jacob T. Elberg

Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School

Learn more about Jacob T. Elberg

2:45 - 3:40

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

3:45

Concluding Remarks