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 October 6-9, 2025 | In-Person/Hybrid
PROGRAM SCHEDULED for June 1-4, 2026 | Virtual
Agenda Below - All Times in Eastern Standard Time
Ethics; Transparency; Federal Health Care Programs; Government Pricing; and Codes of Ethics
8:30 - 9:00
Registration & Breakfast
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
9:25 - 10:15
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
10:15 - 10:35
Break
10:35 - 12:00
Navigating State, Federal & International Transparency Disclosure Requirements
Keren Bisnauth
Director - US Innovative Medicines and Biosimilars, Teva Pharmaceuticals
12:00 - 1:00
Lunch Break
1:00 - 2:10
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.
2:15 - 3:30
Government Pricing Regulation: Key Issues for Compliance Professionals
Kathleen Peterson
Counsel, Global Regulatory, Hogan Lovells
3:30 - 3:50
Break
3:50 - 5:05
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Katie C. Pawlitz
Partner, Reed Smith LLP
Anti-Kickback Statute; False Claims Act; Diversity, Equity & Inclusion; Foreign Corrupt Practices Act; and Corporate Integrity Agreements
8:30 - 9:00
Registration & Breakfast
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 False Claims Act and Dealing with Whistleblowers
Pamela Coyle Brecht
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP
John J. Pease, III
Partner, Morgan, Lewis & Bockius LLP
11:55 - 12:55
Lunch Break
12:55 - 1:55
Diversity, Equity and Inclusion in the Compliance Industry
Shirell A. Gross
Vice President and Global Chief Counsel for Global Operations & Supply Chain, Medtronic
Julia A. López
Partner, Reed Smith LLP
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
2:00 - 3:15
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
John S. (Jay) Darden
Partner, Litigation Department, Paul Hastings LLP
3:15 - 3:35
Break
3:35 - 4:50
Compliance Lessons Learned from Corporate Integrity Agreements
Brian Bohnenkamp
Partner, FDA & Life Sciences, King & Spalding LLP
Advertising & Promotion; FDA Regulation; Case Study; and Compliance Officers’ Panel
8:30 - 9:00
Registration & Breakfast
9:00 - 10:15
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Gillian M. Russell
Counsel, FDA & Life Sciences, King & Spalding LLP
10:15 - 10:30
Break
10:30 - 11:45
Track 1 (Rodino Reading Room): FDA Regulation of Drug Development & Approval
Julia Post
Of Counsel, Covington & Burling LLP
10:30 - 11:45
Track 2 (Room 371): Overview of U.S. Medical Device Regulation
Scott Danzis
Partner, Covington & Burling LLP
11:45 - 12:45
Lunch Break
12:45 - 2:15
Compliance Case Study Workshop: Break-Out Sessions
2:20 - 3:25
Compliance Case Study Workshop: Break-Out Sessions & Workshop
Regina Gore Cavaliere
Vice President, Regulatory & Compliance, Chief
Ethics & Compliance Officer, Henry Schein, Inc.
Michael “Mickey” Kim
Chief Compliance Officer for HOYA Vision Care and HOYA Surgical Optics
Angelique Lee
Principal, Strategic Advisor, Golden West Compliance Solutions
Jennifer McGee
Sr. VP & Global Chief Compliance Officer (Ret.), Otsuka Pharmaceutical
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Joseph Zimmerman
Sr. VP, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
3:25 - 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.
Michael “Mickey” Kim
Chief Compliance Officer for HOYA Vision Care and HOYA Surgical Optics
Angelique Lee
Principal, Strategic Advisor, Golden West Compliance Solutions
Jennifer McGee
Sr. VP & Global Chief Compliance Officer (Ret.), Otsuka Pharmaceutical
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Joseph Zimmerman
Sr. VP, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
5:00 - 6:30
Cocktail Reception - Franzese Faculty Library, 5th Floor (and virtually via ZOOM until 6:00 PM EST)
Data Analytics and AI; Privacy & Data Protection; Health Care Fraud Enforcement, and Investigations
8:30 - 9:00
Registration & Breakfast
9:00 - 10:20
Data Analytics and AI in Compliance
Stacy Aiken
Sr. Director, Enterprise Risk Management BPO, Johnson & Johnson
Michael Driscoll
Managing Member, Driscoll & DeSimone, LLC & Former, Director, Global Strategic Insights, Health Care Compliance, Johnson & Johnson
Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
10:20 - 10:40
Break
10:40 - 12:00
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Jeremy Berkowitz
Sr. Privacy Director & Deputy Chief Privacy Officer, Paul Hastings LLP
12:00 - 1:00
Lunch Break
1:00 - 1:55
Before I Was a Compliance Officer …
James Sheehan
Chief, Charities Bureau, Office of the New York Attorney General
2:00 - 3:05
Panel Discussion: Being the Focus of a Government Investigation
Jane H. Yoon
Partner, Litigation Department, Paul Hastings LLP
James Sheehan
Chief, Charities Bureau, Office of the New York Attorney General
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
3:05 - 3:15
Concluding Remarks
3:15
Grab & Go Refreshments
