Healthcare Compliance Training - Program Schedule
U.S. Healthcare Compliance Certificate Program
[email protected] | 973-642-8382 or 973-761-9000 ext. 8382
PROGRAM SCHEDULED for October 7-10, 2024 | Virtual
or PROGRAM SCHEDULED for June 2-5, 2025 | In-Person
Agenda Below - All Times in Eastern Standard Time
Day 1 - Monday, October 7, 2024
Ethics; Transparency; Federal Health Care Programs; Government Pricing; and FDA Regulation
Registration
Welcome, Program & 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
Introductions & Icebreaker
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
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
Break
Navigating Global Transparency Disclosure Requirements
Keren F. Bisnauth
Associate Vice President, Legal & Regulatory, Porzio Life Sciences, LLC (an RLDatix Company)
Lunch Break
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.
Government Pricing Regulation: Key Issues for Compliance Professionals
Kathleen Peterson
Counsel, Global Regulatory, Hogan Lovells
Break
Track 1: FDA Regulation of Drug Development & Approval
Julia Post
Of Counsel, Covington & Burling LLP
Track 2: Overview of U.S. Medical Device Regulation
Scott Danzis
Partner, Covington & Burling LLP
Day 2 - Tuesday, October 8, 2024
False Claims Act; Codes of Ethics; Foreign Corrupt Practices Act; Diversity, Equity and Inclusion; Advertising & Promotion; and Speaker Programs
Registration
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
Break
AdvaMed v.PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Katie C. Pawlitz
Partner, Reed Smith LLP
Lunch Break
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
Gary Giampetruzzi
Partner, Litigation Department, Paul Hastings LLP
Stephen Chien
Vice President, Global Compliance Operations, Gilead Sciences
Diversity, Equity and Inclusion in the Compliance Industry
Sunita Patel
Counsel, Bristol Myers Squibb
Sapna Palla
Partner, A&O Shearman
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Break
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Gillian M. Russell
Counsel, FDA & Life Sciences, King & Spalding LLP
Nikki Reeves
Partner, FDA & Life Sciences, King & Spalding LLP
Compliance Risks Associated with Speaker Programs
Craig Carpenito
Partner, Special Matters & Government Investigations, King & Spalding LLP
Adam Baker
Partner, Special Matters & Government Investigations, King & Spalding LLP
Optional Virtual Networking Reception
Day 3 - Wednesday, October 9, 2024
Corporate Integrity Agreements; Anti-Kickback Statute; Case Study; and Compliance Officers’ Panel
Registration
Compliance Lessons Learned from Corporate Integrity Agreements
Seth Lundy
Partner, FDA and Life Sciences, King & Spalding LLP
Break
The Federal Anti-Kickback Statute
Bruce Levy
Partner, Hartmann Doherty Rosa Berman & Bulbulia
Compliance Case Study Workshop: Break-Out Sessions
Lunch Break
Compliance Officers Panel Discussion
Joseph Zimmerman
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
Christie Camelio
Senior Vice President, Chief Compliance Officer, Insmed
Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.
Jill Fallows Macaluso
Corp. VP & North America Chief Ethics & Compliance Officer, Novo Nordisk
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Angelique Lee
VP, Chief Compliance & Ethics Officer, Jazz Pharmaceuticals
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Break
Compliance Case Study Workshop: Break-Out Sessions & Workshop
Joseph Zimmerman
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
Christie Camelio
Senior Vice President, Chief Compliance Officer, Insmed
Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.
Jill Fallows Macaluso
Corp. VP & North America Chief Ethics & Compliance Officer, Novo Nordisk
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Day 4 - Thursday, October 10, 2024
Privacy, Data Analytics, and Health Care Fraud Enforcement, and Investigations
Registration
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
Jeremy Berkowitz
Senior Privacy Director & Deputy Chief Privacy Officer, Paul Hastings, LLP
Break
Data Analytics
Anna Loveless
Associate Director, Advanced Solutions within the Global Development Organization, Johnson & Johnson Innovative Medicine
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
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
Vikas Khanna
First Assistant U.S. Attorney, U.S. Attorney’s Office, District of New Jersey
Lunch Break
Panel Discussion: Being the Focus of a Government Investigation
Vikas Khanna
First Assistant U.S. Attorney, 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, New York Attorney General’s Office
Katie Holden
Federal Bureau of Investigations, Newark Field Office
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Before I Was a Compliance Officer …
James Sheehan
Chief, Charities Bureau, New York Attorney General’s Office
Concluding Remarks