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 June 12-15, 2023 | In-person
or PROGRAM SCHEDULED for October 9-12, 2023 | Virtual
Note: Agenda Available Below - All Times in Eastern Standard Time
Day1 | |
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Ethics, Transparency, Privacy, Federal Health Care Programs, and Government Pricing |
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8:45 a.m. |
REGISTRATION OPENS
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9:00 – 9:45 |
Welcome, Program Introduction & Format Review![]() Rosa Alves ![]() Jacob Elberg |
9:50 – 10:45 |
The Relationship Between Ethics and Legal Compliance![]() Jacob Elberg |
10:45 – 11:00 |
BREAK
|
11:00 – 12:15 |
Navigating State, Federal & International Transparency Disclosure Requirements![]() Keren Bisnauth |
12:15 – 1:00 |
LUNCH BREAK |
1:00 – 2:20 |
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations![]() Anna Spencer |
2:25 – 3:40 |
An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers![]() Philo D. Hall |
3:40 – 4:00 |
BREAK
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4:00 – 5:00 |
Government Pricing Regulation: Key Issues for Compliance Professionals![]() Kathleen Peterson |
Day2 | |
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False Claims Act, Anti-Kickback Statute, FDA Regulation, Foreign Corrupt Practices Act, and Speaker Programs |
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8:45 a.m. |
REGISTRATION
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9:00 – 9:55 |
A Journey to the Dark Side of International Business: Real-World Risk and Real-World Lessons![]() Richard Bistrong ![]() Moderator: Jane Yoon |
10:00 – 11:15 |
The False Claims Act and Dealing with Whistleblowers![]() Meredith Auten ![]() Pamela Coyle Brecht |
11:15 – 11:30 |
BREAK
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11:30 – 12:45 |
The Federal Anti-Kickback Statute![]() Bruce Levy ![]() Freddy Jimenez |
12:45 – 1:45 |
LUNCH BREAK |
1:45 – 3:00 |
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)![]() Gary Giampetruzzi ![]() Nicole Stovall |
3:05 – 3:50 |
Compliance Risks Associated with Speaker Programs![]() Craig Carpenito ![]() Amy Boring |
3:50 – 4:05 |
BREAK
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4:05 – 5:10 |
Track 1: FDA Regulation of Drug Development & Approval![]() Julia Post
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5:15 – 6:00 |
VIRTUAL NETWORKING RECEPTION
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Day3 | |
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Advertising & Promotion, Data Analytics, Corporate Integrity Agreements, Case Study, and Compliance Officers' Panel |
|
8:45 a.m. |
REGISTRATION
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9:00– 10:05 |
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities![]() Nikki Reeves ![]() Gillian M. Russell |
10:05 – 10:20 |
BREAK |
10:20 – 11:35 |
Data Analytics![]() Michael Driscoll ![]() Jacob Elberg ![]() Anna Loveless |
11:40 – 12:40 |
Compliance Lessons Learned from Corporate Integrity Agreements![]() Seth Lundy |
12:40 – 1:40 |
LUNCH BREAK |
1:40 – 3:40 |
Compliance Case Study Workshop: Break-Out Session & Workshop![]() Jill Fallows Macaluso ![]() Joe Zimmerman ![]() Margaret Sparks ![]() Jennifer McGee ![]() Regina Gore Cavaliere |
3:40 – 3:55 |
BREAK |
3:55 – 5:15 |
Compliance Officers Panel Discussion![]() Margaret Sparks ![]() Jennifer McGee ![]() Regina Gore Cavaliere ![]() Michael (Mickey) Kim ![]() Jill Fallows Macaluso ![]() Joe Zimmerman ![]() Moderator: Kathleen Boozang |
Day4 | |
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Patient Interactions, Industry Guidance, Health Care Fraud Enforcement, and Investigations |
|
8:45 a.m. |
REGISTRATION
|
9:00– 10:00 |
Diversity, Equity and Inclusion in the Compliance Industry
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10:00 – 10:25 |
BREAK |
10:25 – 11:25 |
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals![]() Katie Pawlitz |
11:30 – 12:30 |
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation![]() Lee Cortes |
12:30 – 1:30 |
LUNCH BREAK |
1:30 – 2:20 |
Before I Was a Compliance Officer ...![]() Jim Sheehan |
2:25 – 3:45 |
Panel Discussion: Being the Focus of a Government Investigation![]() Lee Cortes ![]() Laurie Allen ![]() Jane Yoon ![]() Jim Sheehan ![]() John Kelly ![]() Moderator: Jacob Elberg |
3:45 |
CONCLUDING REMARKS
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