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 May 20-23, 2024 | In-Person
or PROGRAM SCHEDULED for October 7-10, 2024 | Virtual
Tentative Agenda Below - All Times in Eastern Standard Time
Day 1
Ethics; Transparency; Federal Health Care Programs; Government Pricing; and FDA Regulation
Registration & Breakfast
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
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 State, Federal & International 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
False Claims Act; Anti-Kickback statute; Foreign Corrupt Practices Act; Diversity, Equity & Inclusion; Corporate Integrity Agreements; and Speaker Programs
Registration & Breakfast
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
The Federal Anti-Kickback Statute
Bruce Levy
Partner, Hartmann Doherty Rosa Berman & Bulbulia
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
Sujata Dayal
Senior Advisor on Global Compliance Initiatives
Sapna Palla
Partner, A&O Shearman
Sunitha Ramamurthy
VP, Global Ethics and Compliance, Eli Lilly
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Break
Compliance Lessons Learned from Corporate Integrity Agreements
Brian Bohnenkamp
Partner, King & Spalding LLP
Learn more about Brian Bohnenkamp
Compliance Risks Associated with Speaker Programs
Adam Baker
Partner, Special Matters & Government Investigations, King & Spalding LLP
Seth Lundy
Partner, FDA and Life Sciences, King & Spalding LLP
Cocktail Reception – Café Deni
Day 3
Privacy & Data Protection; Advertising & Promotion; Case Study; and Compliance Officers’ Panel
Registration & Breakfast
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
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
Gillian M. Russell
Counsel, FDA & Life Sciences, King & Spalding LLP
Lunch Break
Compliance Case Study Workshop: Break-Out Sessions
Compliance Case Study Workshop: Break-Out Sessions & Workshop
Joseph Zimmerman
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
Regina Gore Cavaliere
Vice President, Regulatory & Compliance, Chief Ethics & Compliance Officer, Henry Schein, Inc.
Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Christie Camelio
Senior Vice President, Chief Compliance Officer, Insmed
Break
Compliance Officers Panel Discussion
Joseph Zimmerman
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
Regina Gore Cavaliere
Vice President, Regulatory & Compliance, Chief Ethics & Compliance Officer, Henry Schein, Inc.
Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.
Michael "Mickey" Kim
Global Chief Compliance Officer, HOYA Medtech and Life Science Segment Company
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
Christie Camelio
Senior Vice President, Chief Compliance Officer, Insmed
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Day 4
Codes of Ethics; Data Analytics; Health Care Fraud Enforcement, and Investigations
Registration & Breakfast
Data Analytics
Stacy Aiken
Director for Global Assessments and Consulting Services, Health Care Compliance Organization, 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
Break
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals
Katie C. Pawlitz
Partner, Reed Smith LLP
A Journey to the Dark Side of International Business: Real-World Risk and Real-World Lessons
Richard Bistrong
CEO, Front-Line Anti-Bribery LLC; former FCPA Violator & FBI/UK Cooperator
Moderator: Jane H. Yoon
Partner, Litigation Department, Paul Hastings LLP
Lunch Break
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
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