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Schedule

Advanced Healthcare Compliance Certificate Program

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Schedule

brett.canaval@shu.edu|973-642-8382

PROGRAM SCHEDULED for May 16-18, 2023| Virtual

All times are listed in Eastern Time.

Day 1

10:00 - 10:45

Program Kickoff, Overview and Participant Introductions

Rosa Alves

Rosa M. Alves

Asst. Dean, Global Compliance, Seton Hall Law School

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Jacob Elberg

Jacob T. Elberg

Professor of Law, Seton Hall Law School

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10:50 - 12:05pm

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

Jacob Elberg

Jacob T. Elberg

Professor of Law, Seton Hall Law School

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Lauren Kootman

Lauren Kootman

Assistant Chief, Corporate Enforcement, U.S. DOJ

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Daniel Kahn

Daniel Kahn

Partner, Davis Polk

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12:05 - 1:05pm

Lunch Break

1:05 - 2:25pm

Implementation of and Demonstrating Adherence to the Guidance

Gary Giampetruzzi

Gary Giampetruzzi

Partner, Litigation Department, Paul Hastings LLP

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Melissa Lozner

Melissa Lozner

Senior Vice President, Chief Compliance Officer,
Regeneron

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Christie Camelio

Christie Camelio

Senior Vice President, Chief Compliance Officer, Insmed

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Yvonne O. Osirim

Yvonne O. Osirim

VP, Human Health Ethics & Compliance, Merck

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2:25 - 2:40pm

Break

2:40 - 4:40pm

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

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Edward Leskauskas

Edward Leskauskas

Head, US Audit, Risk Assessment & Field Monitoring, Sanofi

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Richard Konzelmann

Richard Konzelmann

Lead US Risk Assessment & Audit, Sanofi

 

Day 2

9:30 - 11:00am

The New Business Ethics and Compliance Function

Piergiorgio Pepe

Piergiorgio Pepe

President, Quantum Ethics

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Lawrence Platkin

Lawrence Platkin

VP & Head, U.S. Office of Compliance (Retired), Bayer U.S. LLC

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Signe Elbaek

Signe Elbaek

Chief Compliance Officer, Mölnlycke Health Care AB

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Jacob Elberg

Moderator: Jacob T. Elberg

Professor of Law, Seton Hall Law School

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11:00 - 11:15am

Break

11:15 - 12:45pm

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

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Joy Dowdle

S. Joy Dowdle

Partner, Litigation Department, Paul Hastings LLP

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12:45 - 1:45pm

Lunch Break

1:45 - 3:30pm

Case Study: Overseas Third Party Management 

Jaimee Reid

Jaimee Reid

Head of Compliance and Privacy Officer, Intercept Pharmaceuticals

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Joy Dowdle

S. Joy Dowdle

Partner, Litigation Department, Paul Hastings LLP

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3:30 - 4:15pm

Virtual Networking Reception for All Program Faculty & Attendees

 

Day 3

10:00 - 11:30am

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.

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Jennifer McGee

Jennifer McGee

Sr. VP & Global Chief Compliance Officer, Otsuka Pharmaceuticals

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Kathleen Boozang

Moderator: Kathleen M. Boozang

Professor of Law, Seton Hall Law School

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11:45 - 12:45am

Lunch Break

12:45 - 1:45pm

Deep Dive into Internal Investigations

Strategies, techniques, tools (analytics, etc.)

Joseph Zimmerman

Joseph Zimmerman

Sr. VP, Chief Compliance Officer, SpringWorks Therapeutics

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Lisa LeCointe-Cephas

Lisa LeCointe-Cephas

Partner & Chair, Life Sciences Sector, DLA Piper

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1:45 - 2:00pm

Break

2:00 - 3:45pm

Case Study

Joseph Zimmerman

Joseph Zimmerman

Sr. VP, Chief Compliance Officer, SpringWorks Therapeutics

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Lisa LeCointe-Cephas

Lisa LeCointe-Cephas

Partner & Chair, Life Sciences Sector, DLA Piper

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3:30 - 4:00pm

Conclusion & Closing Remarks