Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School
[email protected] | 973-642-8382 or 973-761-9000 ext. 8382
PROGRAM SCHEDULED for June 1-4, 2026 | Virtual
PROGRAM SCHEDULED for October 5-8, 2026 | In-Person
Agenda Below - All Times in Eastern Standard Time
Ethics; Transparency; Federal Health Care Programs; Government Pricing; and Diversity, Equity & Inclusion
8:45 - 9:00
Sign-On & Registration
9:00 - 9:20
Welcome, Program Introduction & Format Review
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
9:20 - 10:00
Introductions and Icebreakers
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
10:05 -10:55
The Relationship Between Ethics and Legal Compliance
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
10:55 - 11:10
Break
11:10 - 12:30
Navigating State, Federal & International Transparency Disclosure Requirements
Keren Bisnauth
Director - US Innovative Medicines and Biosimilars, Teva Pharmaceuticals
Brian Sharkey
Head of NA Compliance & Ethics, Teva Pharmaceuticals
Learn more about Brian Sharkey
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
Member of the Firm, Epstein Becker & Green, P.C.
2:45 - 4:00
Government Pricing Regulation: Key Issues for Compliance Professionals
Kathleen Peterson
Counsel, Global Regulatory, Hogan Lovells
4:00 - 4:15
Break
4:15 - 5:05
Diversity, Equity and Inclusion in the Compliance Industry
Shirell Gross
Vice President and Global Chief Counsel for Global Operations & Supply Chain, Medtronic
Julia A. López
Partner, Reed Smith LLP
Sunita Patel
Counsel, Bristol Myers Squibb
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Anti-Kickback Statute; Foreign Corrupt Practices Act; Case Study; and Compliance Officers' Panel
8:45 - 9:00
Registration & Sign-On
9:00 - 10:15
The Federal Anti-Kickback Statute
Bruce Levy
Partner, Hartmann Doherty Rosa Berman & Bulbulia
10:15 - 10:35
Break
10:35 - 11:55
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
Gary Giampetruzzi
Partner, Litigation Department, Paul Hastings LLP
Jonathan Mehta
Vice President, Healthcare Compliance, Regional Sector Lead, MedTech Asia Pacific, Johnson & Johnson
Learn more about Jonathan Mehta
John Perez
Senior Director, Global Health Care Compliance Program Management Lead, Johnson & Johnson
Learn more about John Perez
11:55 - 12:55
Lunch Break
12:55 - 2:15
Compliance Case Study Workshop: Break-Out Sessions
2:20 - 3:30
Compliance Case Study Workshop: Break-Out Sessions & Workshop
Regina Gore Cavaliere
Vice President, Regulatory & Compliance, Chief Ethics & Compliance Officer, Henry Schein, Inc.
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Joseph Zimmerman
Vice President, Chief Compliance Officer, Incyte Corporation
Jill Fallows Macaluso
Corporate Vice President and Chief Ethics, Compliance & Privacy Officer, Novo Nordisk, Inc.
Angelique Lee
Principal, Strategic Advisor, Golden West Compliance Solutions
3:30 - 3:45
Break
3:45 - 5:00
Compliance Officers Panel Discussion
Regina Gore Cavaliere
Vice President, Regulatory & Compliance, Chief Ethics & Compliance Officer, Henry Schein, Inc.
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Joseph Zimmerman
Vice President, Chief Compliance Officer, Incyte Corporation
Michael “Mickey” Kim
Chief Compliance Officer for HOYA Vision Care and HOYA Surgical Optics
Jill Fallows Macaluso
Corporate Vice President and Chief Ethics, Compliance & Privacy Officer, Novo Nordisk, Inc.
Angelique Lee
Principal, Strategic Advisor, Golden West Compliance Solutions
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
5:00 - 6:00
Virtual Networking Reception
False Claims Act, Advertising & Promotion; FDA Regulation; Codes of Ethics; and Corporate Integrity Agreements
8:45 - 9:00
Registration & Sign-On
9:00 - 10:20
The False Claims Act and Dealing with Whistleblowers
Pamela Coyle Brecht
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP
Learn more about Pamela Coyle Brecht
Meredith Auten
Partner, Holland & Knight
10:20 - 10:35
Break
10:35 - 11:55
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Gillian M. Russell
Counsel, FDA & Life Sciences, King & Spalding LLP
11:55 - 12:55
Lunch Break
12:55 - 2:10
Track 1: FDA Regulation of Drug Development & Approval
Track 2: Overview of U.S. Medical Device Regulation
Julia Post
Of Counsel, Covington & Burling LLP
Scott Danzis
Partner, Covington & Burling LLP
2:15 - 3:30
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Katie C. Pawlitz
Partner, Reed Smith LLP
3:30 - 3:45
Break
3:45 - 5:00
Compliance Lessons Learned from Corporate Integrity Agreements
Brian Bohnenkamp
Partner, FDA & Life Sciences, King & Spalding LLP
Privacy & Data Protection; Data Analytics and AI; Health Care Fraud Enforcement; and Investigations
8:45 - 9:00
Registration & Sign-On
9:00 - 10:20
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Jeremy Berkowitz
Sr. Privacy Director & Deputy Chief Privacy Officer, Paul Hastings LLP
10:20 - 10:40
Break
10:40 - 11:55
Data Analytics and AI in Compliance
Stacy Aiken
Sr. Director, Enterprise Risk Management BPO, Johnson & Johnson
Anna Lovless
Manager for Monitoring, Innovation and Infrastructure, Johnson & Johnson
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
11:55 - 12:55
Lunch Break
12:55 - 1:50
Before I Was a Compliance Officer …
James Sheehan
Chief, Charities Bureau, Office of the New York Attorney General
1:55 - 2:45
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
David Dauenheimer
Assistant U.S. Attorney, Deputy Chief, United States Attorney's Office, District of New Jersey
Learn more about David Dauenheimer
2:50 - 3:45
Panel Discussion: Being the Focus of a Government Investigation
David Dauenheimer
Assistant U.S. Attorney, Deputy Chief, United States Attorney's Office, District of New Jersey
Jane H. Yoon
Partner, Litigation Department, Paul Hastings LLP
James Sheehan
Chief, Charities Bureau, Office of the New York Attorney General
John Kelly
Partner & Chair of the Healthcare Department and Industry Practice Barnes & Thornburg LLP
Katie Holden
Federal Bureau of Investigation (FBI)
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
3:45
Concluding Remarks
