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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 May 20-23, 2024 | In-Person
or PROGRAM SCHEDULED for October 7-10, 2024 | Virtual

 
 
 

Sample Agenda Below - All Times in Eastern Standard Time

Day 1 
 

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

8:45 - 9:00

REGISTRATION
 

9:00 – 9:20

Welcome, Program & Format Review

Rosa Alves

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

Timothy Glynn

Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School
Learn more about Timothy Glynn

9:25 – 9:50

Introductions & Icebreaker

Rosa Alves

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

Timothy Glynn

Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School
Learn more about Timothy Glynn

9:55 – 10:45

The Relationship Between Ethics and Legal Compliance

Timothy Glynn

Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School
Learn more about Timothy Glynn

10:45 – 11:00

BREAK
 

11:00 – 12:20

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

12:20 – 1:20

LUNCH BREAK

1:20 – 2:25

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

2:30 – 3:40

Government Pricing Regulation: Key Issues for Compliance Professionals

Kathleen Peterson

Kathleen Peterson
Counsel, Global Regulatory, Hogan Lovells
Learn more about Kathleen Peterson

3:40 – 3:55

BREAK
 

3:55 – 5:05

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

 

Day 2  
 

False Claims Act, Anti-Kickback Statute, Foreign Corrupt Practices Act, Advertising & Promotion, and Speaker Programs

8:45

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

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

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

Piyush Sharma

Piyush Sharma
Chief Ethics & Compliance Officer, Alnylam Pharmaceuticals, Inc.
Learn more about Piyush Sharma

2:10 – 3:35

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

3:35 – 3:50

BREAK
 

3:50 – 4:40

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

4:45 – 5:30

VIRTUAL NETWORKING RECEPTION
 

Day 3 
 

Privacy, Data Analytics, Corporate Integrity Agreements, Case Study, and Compliance Officers' Panel

8:45

REGISTRATION 
 

9:00 – 10:20

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

10:20 – 10:35

NETWORKING BREAK

10:35 – 11:35

Compliance Lessons Learned from Corporate Integrity Agreements

Seth Lundy

Seth Lundy
Partner, FDA and Life Sciences, King & Spalding LLP
Learn more about Seth Lundy

12:45 – 1:45

LUNCH BREAK

1:45 – 2:45

Data Analytics

Stacy Aiken

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

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 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

2:50 – 4:00

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

Jennifer McGee

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

Christie Camelio

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

Paul Curtin

Paul Curtin
Senior Vice President, Global Chief Compliance & Privacy Officer, Intercept Pharmaceuticals, Inc.
Learn more about Paul Curtin

Sujata Dayal

Sujata Dayal
Independent Board Member, Emergent BioSolutions

4:00 – 4:15

BREAK

4:15 – 5:30

Compliance Officers Panel Discussion

Joe Zimmerman

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

Jennifer McGee

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

Christie Camelio

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

Paul Curtin

Paul Curtin
Senior Vice President, Global Chief Compliance & Privacy Officer, Intercept Pharmaceuticals, Inc.
Learn more about Paul Curtin

Michael (Mickey) Kim

Michael "Mickey" Kim
Global Chief Compliance Officer, PENTAX Medical
Learn more about Michael "Mickey" Kim

Sujata Dayal

Sujata Dayal
Independent Board Member, Emergent BioSolutions

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

Day 4 
 

Patient Interactions, Diversity, Equity & Inclusion, Health Care Fraud Enforcement, and Investigations

8:45

REGISTRATION
 

9:00 – 10:10

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

10:10 – 10:30

BREAK

10:30 – 11:30

Diversity, Equity and Inclusion in the Compliance Industry

Nicole Stovall

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

Alison Hinds-Pearl

Alison Hinds-Pearl
Vice President, Chief Compliance Officer & Assistant General Counsel, Revlon
Learn more about Alison Hinds-Pearl

Sujata Dayal

Sujata Dayal
Independent Board Member, Emergent BioSolutions

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

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 – 2:45

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

Bruce Wayne

Bruce Wayne
Supervisory Special Agent (SSA), Federal Bureau of Investigation (FBI) – Newark Division
Learn more about Bruce Wayne

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

2:50 – 3:40

Before I Was a Compliance Officer ...

Jim Sheehan

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

3:45 - 4:00

CONCLUDING REMARKS