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
Agenda Below - All Times in Eastern Standard Time
Day 1 - Monday, May 20, 2024
Ethics; Transparency; Federal Health Care Programs; Government Pricing; and FDA Regulation
Registration & Breakfast
Welcome, Program Introduction & Format Review
![Rosa M. Alves](/images/rosa-alves-176x176.jpg)
Rosa M. Alves
Assistant Dean for Global Compliance & Programming, Seton Hall Law School
![Jacob T. Elberg](/images/jacob-elberg-176x176.jpg)
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](/images/jacob-elberg-176x176.jpg)
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 Bisnauth](/images/keren-bisnauth-final.jpg)
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](/images/philo-hall-final.jpg)
Philo D. Hall
Member of the Firm, Epstein Becker & Green, P.C.
Government Pricing Regulation: Key Issues for Compliance Professionals
![Kathleen Peterson](/images/kathleen-peterson-final.jpg)
Kathleen Peterson
Counsel, Global Regulatory, Hogan Lovells
Break
Track 1: FDA Regulation of Drug Development & Approval
![Julia Post](/images/julia-post.jpg)
Julia Post
Of Counsel, Covington & Burling LLP
Track 2: Overview of U.S. Medical Device Regulation
![Scott Danzis](/images/scott-danzis-final.jpg)
Scott Danzis
Partner, Covington & Burling LLP
Day 2 - Tuesday, May 21, 2024
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](/images/meredith-auten-final.jpg)
Meredith Auten
Partner, Morgan, Lewis & Bockius LLP
![Pamela Coyle Brecht](/images/pamela-coyle-brecht-final.jpg)
Pamela Coyle Brecht
Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP
Break
The Federal Anti-Kickback Statute
![Bruce Levy](/images/bruce-levy-final-version.jpg)
Bruce Levy
Partner, Hartmann Doherty Rosa Berman & Bulbulia
Lunch Break
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
![Gary Giampetruzzi](/images/gary.giampetruzzi-final.jpg)
Gary Giampetruzzi
Partner, Litigation Department, Paul Hastings LLP
![Blank](/images/blank.png)
Stephen Chien
Vice President, Global Compliance Operations, Gilead Sciences
Diversity, Equity and Inclusion in the Compliance Industry
![Sujata Dayal](/images/sujata-dayal-5.17.24.jpg)
Sujata Dayal
Senior Advisor on Global Compliance Initiatives
![Sapna Palla](/images/sapna-palla.jpg)
Sapna Palla
Partner, A&O Shearman
![Blank](/images/blank.png)
Sunitha Ramamurthy
VP, Global Ethics and Compliance, Eli Lilly
![Jacob T. Elberg](/images/jacob-elberg-176x176.jpg)
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](/images/brian-bohnenkamp.jpg)
Brian Bohnenkamp
Partner, King & Spalding LLP
Learn more about Brian Bohnenkamp
Compliance Risks Associated with Speaker Programs
![Adam Baker](/images/adam-baker.jpg)
Adam Baker
Partner, Special Matters & Government Investigations, King & Spalding LLP
![Seth Lundy](/images/seth-lundy.5.17.24.jpg)
Seth Lundy
Partner, FDA and Life Sciences, King & Spalding LLP
Cocktail Reception – Café Deni
Day 3 - Wednesday, May 22, 2024
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](/images/jeremy-berkowitz.jpg)
Jeremy Berkowitz
Senior Privacy Director & Deputy Chief Privacy Officer, Paul Hastings, LLP
Break
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
![Gillian M. Russell](/images/gillian-russell-final-5.9.24.jpg)
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](/images/joe-zimmerman-final.jpg)
Joseph Zimmerman
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
![Regina Gore Cavaliere](/images/regina-gore-cavaliere-final5.9.24.jpg)
Regina Gore Cavaliere
Vice President, Regulatory & Compliance, Chief Ethics & Compliance Officer, Henry Schein, Inc.
![Jennifer McGee](/images/jennifer-mcgee-final1.jpg)
Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.
![Margaret Sparks](/images/margaret-sparks.jpg)
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
![Christie Camelio](/images/christie-camelio.jpg)
Christie Camelio
Senior Vice President, Chief Compliance Officer, Insmed
Break
Compliance Officers Panel Discussion
![Joseph Zimmerman](/images/joe-zimmerman-final.jpg)
Joseph Zimmerman
Senior Vice President, Chief Compliance Officer, SpringWorks Therapeutics, Inc.
![Regina Gore Cavaliere](/images/regina-gore-cavaliere-final5.9.24.jpg)
Regina Gore Cavaliere
Vice President, Regulatory & Compliance, Chief Ethics & Compliance Officer, Henry Schein, Inc.
![Jennifer McGee](/images/jennifer-mcgee-final1.jpg)
Jennifer McGee
Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceuticals, Inc.
![Michael Kim](/images/michael-kim.jpg)
Michael "Mickey" Kim
Global Chief Compliance Officer, HOYA Medtech and Life Science Segment Company
![Margaret Sparks](/images/margaret-sparks.jpg)
Margaret Sparks
Head of Compliance, Vaccines (U.S.), North America Ethics and Business Integrity, Sanofi
![Christie Camelio](/images/christie-camelio.jpg)
Christie Camelio
Senior Vice President, Chief Compliance Officer, Insmed
![Jacob T. Elberg](/images/jacob-elberg-176x176.jpg)
Moderator: Jacob T. Elberg
Professor of Law and Faculty Director, Center for Health & Pharmaceutical Law, Seton Hall Law School
Day 4 - Thursday, May 23, 2024
Codes of Ethics; Data Analytics; Health Care Fraud Enforcement, and Investigations
Registration & Breakfast
Data Analytics
![Stacy Aiken](/images/stacy-aiken-5.12.24.jpg)
Stacy Aiken
Director for Global Assessments and Consulting Services, Health Care Compliance Organization, Johnson & Johnson
![Michael Driscoll](/images/michael-driscoll-final.jpg)
Michael Driscoll
Managing Member, Driscoll & DeSimone, LLC & Former, Director, Global Strategic Insights, Health Care Compliance, Johnson & Johnson
![Jacob T. Elberg](/images/jacob-elberg-176x176.jpg)
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](/images/katie-pawlitz.jpg)
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](/images/richard-bistrong.jpg)
Richard Bistrong
CEO, Front-Line Anti-Bribery LLC; former FCPA Violator & FBI/UK Cooperator
![Jane Yoon](/images/jane-yoon.jpg)
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](/images/vikas-khanna.jpg)
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](/images/vikas-khanna.jpg)
Vikas Khanna
First Assistant U.S. Attorney, U.S. Attorney’s Office, District of New Jersey
![Jane Yoon](/images/jane-yoon.jpg)
Jane H. Yoon
Partner, Litigation Department, Paul Hastings LLP
![John Kelly](/images/john-kelly-final.jpg)
John Kelly
Partner & Chair of the Healthcare Department and Industry Practice, Barnes & Thornburg LLP
![Jim Sheehan](/images/sheehan-james-final.jpg)
James Sheehan
Chief, Charities Bureau, New York Attorney General’s Office
![Blank](/images/blank.png)
Katie Holden
Federal Bureau of Investigations, Newark Field Office
![Jacob T. Elberg](/images/jacob-elberg-176x176.jpg)
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 …
![Jim Sheehan](/images/sheehan-james-final.jpg)
James Sheehan
Chief, Charities Bureau, New York Attorney General’s Office
Concluding Remarks
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