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 2-5, 2025 | In-Person
PROGRAM SCHEDULED for October 6-9, 2025 | In-Person/Hybrid
Agenda Below - All Times in Eastern Standard Time
Ethics; Transparency; Diversity, Equity & Inclusion; Government Pricing; and FDA Regulation
8:30 - 9:00am
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
Audrey F. DeGuarde
Vice President of Compliance Operations, RLDatix Life Sciences (formerly Porzio Life Sciences)
12:00 - 1:00
Lunch Break
1:00 - 2:00
Diversity, Equity and Inclusion in the Compliance Industry
Shirell A. Gross
Vice President and Global Chief Counsel for Global Operations & Supply Chain, Medtronic
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
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 - 5:00
Track 1 (Rodino Reading Room): FDA Regulation of Drug Development & Approval
Matthew Hegreness
Partner, Covington & Burling LLP
3:50 - 5:00
Track 2 (Room 370): Overview of U.S. Medical Device Regulation
Scott Danzis
Partner, Covington & Burling LLP
False Claims Act; Foreign Corrupt Practices Act; Case Study; and Compliance Officers’ Panel
8:30 - 9:00
Registration & Breakfast
9:00 - 10:15
The False Claims Act and Dealing with Whistleblowers
Meredith Auten
Partner, Morgan, Lewis & Bockius LLP
Pamela Coyle Brecht
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP
10:15 - 10:30
Break
10:30 - 11:45
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
Gary Giampetruzzi
Partner, Litigation Department, Paul Hastings LLP
March Coleman
AVP, Ethics & Compliance, Merck
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.
Christie Camelio
Sr. VP, Chief Compliance Officer, Insmed
Michael “Mickey” Kim
Global Chief Compliance Officer, HOYA Medtech and Life Science Segment Company
Jennifer McGee
Sr. VP & Global Chief Compliance Officer (Ret.), Otsuka Pharmaceutical
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.
Christie Camelio
Sr. VP, Chief Compliance Officer, Insmed
Michael “Mickey” Kim
Global Chief Compliance Officer, HOYA Medtech and Life Science Segment Company
Jennifer McGee
Sr. VP & Global Chief Compliance Officer (Ret.), Otsuka Pharmaceutical
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 – Café Deni
Data Analytics; Anti-Kickback Statute; Advertising & Promotion; Federal Health Care Programs; and Privacy & Data Protection
8:30 - 9:00
Registration & Breakfast
9:00 - 9:55
Data Analytics
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
9:55 - 10:10
Break
10:10 - 11:25
The Federal Anti-Kickback Statute
Bruce Levy
Partner, Hartmann Doherty Rosa Berman & Bulbulia
11:30 - 12:45
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Gillian M. Russell
Counsel, FDA & Life Sciences, King & Spalding LLP
12:45 - 1:45
Lunch Break
1:45 - 2:55
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.
3:00 - 4:15
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Jeremy Berkowitz
Sr. Privacy Director & Deputy Chief Privacy Officer, Paul Hastings LLP
4:15 - 4:30
Refreshments
Corporate Integrity Agreements; and Speaker Programs; Codes of Ethics; Health Care Fraud Enforcement, and Investigations
8:30 - 9:00
Registration & Breakfast
9:00 - 10:05
Compliance Lessons Learned from Corporate Integrity Agreements
Brian Bohnenkamp
Partner, FDA & Life Sciences, King & Spalding LLP
10:05 - 10:25
Break
10:25 - 11:15
Compliance Risks Associated with Speaker Programs
Adam Baker
Partner, Special Matters & Government Investigations, King & Spalding LLP
Craig Carpenito
Partner, Special Matters & Government Investigations, King & Spalding LLP
11:20 - 12:30
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Katie C. Pawlitz
Partner, Reed Smith LLP
12:30 - 1:30
Lunch Break
1:30 - 2:30
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
Joshua L. Haber
Chief of the Criminal Division, U.S. Attorney’s Office for the District of New Jersey
2:35 - 3:30
Panel Discussion: Being the Focus of a Government Investigation
Joshua L. Haber
Chief of the Criminal Division, U.S. Attorney’s Office for the District of New Jersey
Jane H. Yoon
Partner, Litigation Department, Paul Hastings LLP
John Kelly
Partner & Chair of the Healthcare Department and Industry
Practice, Barnes & Thornburg LLP
Katie Holden
Federal Bureau of Investigation, Newark Field Office
Moderator: Timothy Glynn
Andrea J. Catania Endowed Professor of Law, Seton Hall Law School
3:30 - 4:00
Concluding Remarks
4:00
Grab & Go Refreshments
