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 5-8, 2026 | In-Person
PROGRAM SCHEDULED for June 7-10, 2027 | Virtual
Agenda Below - All Times in Eastern Standard Time
ETHICS; TRANSPARENCY; FEDERAL HEALTH CARE PROGRAMS; FALSE CLAIMS ACT; AND FDA REGULATION
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
Brian Sharkey
Head of NA Compliance & Ethics, 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.
2:15-3:35
The False Claims Act and Dealing with Whistleblowers
Pamela Coyle Brecht
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP
Meredith Auten
Partner, Holland & Knight
3:35-3:55
Break
3:55-5:15
The Federal Anti-Kickback Statute
Bruce Levy
Partner, Hartmann Doherty Rosa Berman & Bulbulia
ANTI-KICKBACK STATUTE; FOREIGN CORRUPT PRACTICES ACT; CASE STUDY; AND COMPLIANCE OFFICER PANEL DISCUSSION
8:30 - 9:00
Registration & Breakfast
9:00 - 10:15
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
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
Daniel Font
Senior Director, Compliance Investigations & Privacy Officer, Daiichi ankyo
11:55 - 12:55
Lunch Break
12:55 - 2:15
Compliance Case Study Workshop: Break-Out Sessions
2:20 - 3:25
Compliance Case Study Workshop: Break-Out Sessions & Workshop
Melissa Lozner
Senior Vice President, Chief Compliance Officer, Regeneron
Terra Buckley
Chief Compliance & Ethics Officer, Bristol Myers Squibb
Timothy Roberts
Global Chief Compliance Officer Legend Biotech
3:25-3:45
Break
3:45 - 5:00
Compliance Officers Panel Discussion
Melissa Lozner
Senior Vice President, Chief Compliance Officer, Regeneron
Terra Buckley
Chief Compliance & Ethics Officer, Bristol Myers Squibb
Timothy Roberts
Global Chief Compliance Officer Legend Biotech
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 or Franzese Faculty Library, 5th Floor
PRIVACY & DATA PROTECTION; DATA ANALYTICS AND AI; DIVERSITY, EQUITY, AND INCLUSION; ADVERTISING & PROMOTION; CODES OF ETHICS; AND CORPORATE INTEGRITY AGREEMENTS
8:30 - 9:00
Registration & Breakfast
9:00-10:15
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Jeremy Berkowitz
Sr. Privacy Director & Deputy Chief Privacy Officer, Paul Hastings LLP
10:15-10:35
Break
10:35-11:55
Data Analytics and AI in Compliance
Stacy Aiken
Sr. Director, Enterprise Risk Management BPO, 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
12:55-2:15
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Gillian M. Russell
Counsel, FDA & Life Sciences, King & Spalding LLP
2:20-3:30
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
GOVERNMENT PRICING; HEALTH CARE FRAUD ENFORCEMENT, AND INVESTIGATIONS
8:30 - 9:00
Registration & Breakfast
9:00 - 10:20
Government Pricing Regulation: Key Issues for Compliance Professionals
Kathleen Peterson
Counsel, Global Regulatory, Hogan Lovells
10:20 - 10:40
Break
10:40-11:40
Before I Was a Compliance Officer …
James Sheehan
Chief, Charities Bureau, Office of the New York Attorney General
11:45-12:35
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
George Brandley
Chief, Healthcare Fraud Unit, U.S. Attorney’s Office, District of New Jersey
12:35-1:35
Lunch Break
1:35-2:35
Panel Discussion: Being the Focus of a Government Investigation
George Brandley
Chief, Healthcare Fraud Unit, U.S. Attorney’s Office, 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
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
2:40
Concluding Remarks
Grab & Go Refreshments
