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: Sample Agenda available below (in Eastern Standard Time).

Day1 .
 

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

8:30 a.m.

Registration Opens
 

9:00 – 9:20

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 Jacob Elberg >>

9:25 – 10:15

The Relationship Between Ethics and Legal Compliance

Jacob Elberg

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

10:15 – 10:35

BREAK
 

10:35 – 12:00

Navigating State, Federal & International Transparency Disclosure Requirements
 

Theo Rosini

Theo Rosini
Counsel, Porzio Life Sciences, LLC
Learn more about Theo Rosini >>

Audrey DeGuarde

Audrey DeGuarde
Vice President, Global Transparency, Porzio Life Sciences, LLC
Learn more about Audrey DeGuarde >>

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 .
 

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

8:30 a.m.

Registration Opens
 

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 >>

Jeremy Abay

Jeremy Abay
Senior Associate, Pietragallo Gordon Alfano Bosick & Raspanti, LLP
Learn more about Jeremy Abay >>

10:15 – 10:30

BREAK
 

10:30 – 11:45

The Federal Anti-Kickback Statute
 

Bruce Levy

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

Freddy Jimenez

Freddy Jimenez
Celldex Therapuetics
Learn more about Freddy 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

 

Pamela Forrest

Pamela Forrest
Partner, Covington & Burling LLP
Learn more about Pamela Forrest >>


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 >>

David Styler

David Styler
Senior Vice President, Chief Compliance Officer, Horizon Therapeutics
Learn more about David Styler >>

3:25 – 3:40

BREAK
 

3:40 – 4:25

Topic To Be Determined

 

Craig Carpenito

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

4:30 – 5:15

Compliance Case Study Workshop: Break-Out Sessions

 

Day3 .
 

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

8:30 a.m.

Registration Opens
 

9:00– 10:30

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 >>

10:30 – 10:50

BREAK

10:50 – 12:05

Data Analytics

Michael J. Driscoll

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

Jacob Elberg

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

Anna Loveless

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

12:05 – 1:05

LUNCH BREAK

1:05 – 2:05

Compliance Lessons Learned from Corporate Integrity Agreements
 

Brian Bohenkhamp

Brian Bohenkhamp
Partner, FDA and Life Sciences, King & Spalding LLP
Learn more about Brian Bohenkhamp >>

2:10 – 3:20

Compliance Case Study Workshop: Break-Out Session & Workshop
 

Joe Zimmerman

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

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 >>

Michael Clarke

Michael Clarke
Vice President, Global Chief Compliance Officer, ConvaTec, Inc.
Learn more about Michael Clarke >>

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
Learn more about Joe Zimmerman >>

Dean Boozang

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

5:00 – 5:45

COCKTAIL RECEPTION- Cafe Deni, Seton Hall Law School
 

Day4 .
 

Patient Interactions, industry guidance, Health Care Fraud Enforcement, and Investigations

8:30 a.m.

Registration Opens
 

9:00– 10:15

Compliance Considerations in the New Age of Patient Advocacy
 

John Kelly

John Kelly
Member, Bass, Berry & Sims PLC
Learn more about John Kelly >>

10:15 – 10:35

BREAK

10:35 – 11:40

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

Jeff Layne

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

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 >>

Laurie Allen

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

Jenny Kramer

Jenny Kramer
Partner, Alston & Bird (New York)
Learn more about Jenny Kramer >>

Scott McBride

Scott McBride
Partner, Lowenstein Sandler LLP
Learn more about Scott McBride >>

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, Seton Hall Law School
Learn more about Jacob Elberg >>

4:00 – 4:15

CONCLUDING REMARKS