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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 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 - 9:00 

Registration


9:00 - 9:20 

Welcome, Program & Format Review


Rosa M. Alves

Rosa M. Alves

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

Learn more about Rosa M. Alves

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 

9:20 - 10:00 

Introductions & Icebreaker


Rosa M. Alves

Rosa M. Alves

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

Learn more about Rosa M. Alves

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 

10:05 - 10:55 

The Relationship Between Ethics and Legal Compliance


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

10:55 - 11:10 

Break


11:10 - 12:30  

Navigating Global Transparency Disclosure Requirements


Keren 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 LLP

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 LLP

Learn more about Gary Giampetruzzi

Blank

Stephen Chien

Vice President, Global Compliance Operations, Gilead Sciences

 

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 

Optional 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

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

Blank

Angelique Lee

VP, Chief Compliance & Ethics Officer, Jazz Pharmaceuticals 

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 - 12:35

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

12:35 - 1:35 

Lunch Break


1:35 - 2:40

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 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 

Jim Sheehan

James Sheehan

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

Learn more about James Sheehan

Blank

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 

Before I Was a Compliance Officer …


Jim Sheehan

James Sheehan

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

Learn more about James Sheehan

3:45 

Concluding Remarks