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3-day Intensive Workshop for Prior Healthcare Compliance Certificate Program Participants


Advanced Healthcare Compliance Certificate Program

3-day Intensive Workshop for Prior Healthcare Compliance Certificate Program Participants

 

[email protected] | 973-642-8382

PROGRAM SCHEDULED for May 13-15, 2025 | Virtual

ABOUT PROGRAM

Seton Hall Law’s Advanced Healthcare Compliance Certificate Program (HCCP) is an intensive, three-day virtual workshop designed for experienced health care compliance and legal professionals who are looking for a deeper dive into key compliance risks, strategic decision making, and policy execution. As the advanced offering, this program builds on the substantive base offered in Seton Hall’s global foundational HCCP. The virtual format is highly participatory, with opportunities for interaction with presenters in each session and a group case study each day to enhance knowledge and application. Expert faculty include legal academics, enforcement officials, compliance professionals, and legal counsel. Attendance at each program will be limited to ensure a small group setting with ample opportunity for participant interaction with faculty and a collegial exchange of ideas. Participants will receive an Advanced HCCP Certificate upon successful completion of the program.

WHO SHOULD ATTEND

The program is designed for compliance and legal professionals who have completed one of Seton Hall Law's global compliance certificate programs (US, APAC, MidEast, LATAM, or EU). The virtual format is highly participatory, with opportunities for interaction with presenters in each session and a group case study each day to enhance knowledge and application.

Tuition cost: $3,150.00

To learn more about this program, contact Brett Canaval at [email protected] or 973-642-8382.

Register for a Deep Dive into Healthcare Compliance in just 3 days!

 

PROGRAM OBJECTIVES

This intensive three (3) day program is designed to:

  1. Provide experienced health care compliance and legal professionals with a deeper dive into key compliance risks, strategic decision making, and policy execution
  2. Builds on the substantive base offered in Seton Hall’s global, foundational Health Care Compliance Certificate Programs
  3. Prepare attendees for positions of greater responsibility within their organizations
  4. Promote interactive learning and critical thinking through small group exercises and case studies
  5. Share strategic ideas and best practices on enterprise-level matters including ethics and culture, risk management, and influencing key business leaders
  6. Identify compliance challenges and opportunities in a post-COVID world
  7. Provide networking opportunities with other senior professionals

Program Agenda/Schedule

Day 1 Topics

  1. A Look Inside the Department of Justice’s Evaluation of Effective Compliance Programs Guidance
  2. Implementation of and Demonstrating Adherence to the Guidance
  3. Risk Assessment Discussion and Case Study

Day 2 Topics

  1. Effective, Ethics-Based Collaboration with Legal and the Business
  2. Third-Party Relationship Management
  3. Case Study: Overseas Third-Party Management

Day 3 Topics

  1. Deep Dive into Internal Investigations
  2. Compliance in a Post-COVID World and Ethical Enterprise Leadership

Compliance Certification Board (CCB) Continuing Education Units (CEUs) are currently pending and expect to be awarded based on individual attendance records.


Note: Agenda - All times are listed in Eastern Time.  

Day 1

 

10:00 - 10:45

Program Kickoff, Overview, and Participant Introductions


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

10:50 - 12:05

A Look Inside the Department of Justice’s Evaluation of Effective Compliance Programs Guidance


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

Lauren Kootman

Lauren Kootman

Assistant Chief, Corporate Enforcement, Compliance & Policy Unit, Fraud Section, Criminal Division, U.S. Department of Justice

Learn more about Lauren Kootman 

Daniel Kahn

Daniel Kahn 

Partner, Davis Polk

Learn more about Daniel Kahn 

12:05 - 1:05 

Lunch Break


1:05 - 2:25

Implementation of and Demonstrating Adherence to the Guidance  


Gary Giampetruzzi

Gary Giampetruzzi

Partner, Litigation Department, Paul Hastings LLP

Learn more about Gary Giampetruzzi

Melissa Lozner

Melissa Lozner

Senior Vice President, Chief Compliance Officer,
Regeneron

Learn more about Melissa Lozner 

Christie Camelio

Christie Camelio

Senior Vice President, Chief Compliance Officer, Insmed

Learn more about Christie Camelio

Yvonne O. Osirim

Yvonne O. Osirim

Vice President, Human Health Ethics & Compliance, Merck & Co., Inc. 

Learn more about Yvonne O. Osirim

2:25 - 2:40 

Break


2:40 - 4:40

Risk Assessment Discussion and Case Study:

  • Overview of Enterprise Risk Assessment
  • Approaches to Compliance Risk Assessment
  • Case Study

Christie Camelio

Christie Camelio

Senior Vice President, Chief Compliance Officer, Insmed

Learn more about Christie Camelio

Edward Leskauskas

Edward Leskauskas

Head of US Audit, Risk Assessment, and Field Monitoring, NA Ethics & Business Integrity, Sanofi

Learn more about Edward Leskauskas

Richard Konzelmann

Richard Konzelmann 

Lead US Risk Assessment & Audit, N.A. Ethics & Business Integrity, Sanofi 

Day 2

 

9:30 - 11:00

The New Business Ethics and Compliance Function 


Piergiorgio Pepe

Piergiorgio Pepe

President, Quantum Ethics

Learn more about Piergiorgio Pepe 

Lawrence Platkin

Lawrence Platkin

Vice President and Head, U.S. Office of Compliance (Retired), Bayer U.S. LLC

Learn more about Lawrence Platkin

Signe Elbaek

Signe Elbaek

Chief Compliance Officer, Mölnlycke Health Care AB (Denmark)

Learn more about Signe Elbaek

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

11:00 - 11:15

Break


11:15 - 12:45

Third-Party Relationship Management

  • Domestic and global risks, due diligence, contracting, monitoring, auditing, termination

Jaimee Reid

Jaimee Reid 

Head of Compliance and Privacy Officer, Intercept Pharmaceuticals

Learn more about Jaimee Reid 

S. Joy Dowdle

S. Joy Dowdle

Partner, Litigation Department, Paul Hastings LLP

Learn more about S. Joy Dowdle 

12:45 - 1:45 

Lunch Break


1:45 - 3:30 

 Case Study: Overseas Third Party Management 


Jaimee Reid

Jaimee Reid 

Head of Compliance and Privacy Officer, Intercept Pharmaceuticals 

Learn more about Jaimee Reid 

S. Joy Dowdle

S. Joy Dowdle

Partner, Litigation Department, Paul Hastings LLP

Learn more about S. Joy Dowdle 

3:30 - 4:15 

Virtual Networking Reception for All Program Faculty & Attendees 


Day 3

 

10:00 - 11:45 

Compliance and Ethical Enterprise Leadership

  • Influencing business leadership, including the Board to confront compliance challenges

Bryant Aaron

Bryant Aaron

Chief Compliance Officer, Elevance Health, Inc. (f/k/a Anthem, Inc.)

Learn more about Bryant Aaron

Jennifer McGee

Jennifer McGee 

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

Learn more about Jennifer McGee

Kathleen M. Boozang

Moderator: Kathleen M. Boozang 

Professor of Law, Seton Hall Law School

Learn more about Kathleen M. Boozang 

11:45 - 12:45 

Lunch Break


12:45 - 1:45 

Deep Dive into Internal Investigations

  • Strategies, techniques, tools (analytics, etc.)

Joseph Zimmerman

Joseph Zimmerman 

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

Learn more about Joseph Zimmerman 

Lisa LeCointe-Cephas

Lisa LeCointe-Cephas

Partner & Chair, Life Sciences Sector, DLA Piper

Learn more about Lisa LeCointe-Cephas

1:45 - 2:00 

Break


2:00 - 3:45 

Case Study


Joseph Zimmerman

Joseph Zimmerman 

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

Learn more about Joseph Zimmerman

Lisa LeCointe-Cephas

Lisa LeCointe-Cephas

Partner & Chair, Life Sciences Sector, DLA Piper

Learn more about Lisa LeCointe-Cephas

3:45 - 4:00 

Conclusion & Closing Remarks