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 Below - All Times in Eastern Standard Time
| Day1 - MOnday, june 12, 2023 | |
|---|---|
Ethics, Transparency, Privacy, Federal Health Care Programs, and Government Pricing |
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|
8:30 – 9:00 a.m. |
REGISTRATION & BREAKFAST
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|
9:00 – 9:20 |
Welcome, Program Introduction & Format Review Rosa M. Alves  Jacob T. Elberg |
|
9:25 – 10:15 |
The Relationship Between Ethics and Legal ComplianceJacob T. Elberg |
|
10:15 – 10:35 |
BREAK
|
|
10:35 – 12:00 |
Navigating State, Federal & International Transparency Disclosure Requirements Keren Bisnauth |
|
12:00 – 1:00 |
LUNCH BREAK |
|
1:00 – 2:30 |
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations Anna Spencer |
|
2:35 – 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 - tuesday, june 13, 2023 | |
|---|---|
False Claims Act, Anti-Kickback Statute, FDA Regulation, Foreign Corrupt Practices Act, and Speaker Programs |
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|
8:30 – 9:00 a.m. |
REGISTRATION & BREAKFAST
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|
9:00 – 10:15 |
The False Claims Act and Dealing with Whistleblowers Meredith Auten  Gregg Shapiro |
|
10:15 – 10:30 |
BREAK
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|
10:30 – 11:45 |
The Federal Anti-Kickback Statute Bruce Levy  Freddy A. Jimenez |
|
11:45 – 12:45 |
LUNCH BREAK |
|
12:45 – 1:55 |
Track 1: FDA Regulation of Drug Development & Approval Julia Post
|
|
2:00 – 3:20 |
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement) Gary Giampetruzzi |
|
3:25 – 3:40 |
BREAK |
|
3:40 – 4:25 |
Compliance Risks Associated with Speaker Programs Craig Carpenito  Adam Baker |
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4:30 – 5:15 |
Compliance Case Study Workshop: Break-Out Sessions |
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5:15 – 6:15 |
COCKTAIL RECEPTION - CAFÈ DENI
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| Day3 - wednesday, june 14, 2023 | |
|---|---|
Advertising & Promotion, Data Analytics, Corporate Integrity Agreements, Case Study, and Compliance Officers' Panel |
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|
8:30 – 9:00 a.m. |
REGISTRATION & BREAKFAST
|
|
9:00 – 10:30 |
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities Gillian M. Russell |
|
10:30 – 10:50 |
BREAK |
|
10:20 – 11:35 |
Data Analytics Stacy Aiken Jacob T. Elberg |
|
12:05 – 1:05 |
LUNCH BREAK |
|
1:05 – 2:05 |
Compliance Lessons Learned from Corporate Integrity Agreements Seth Lundy  Brian Bohnenkamp |
|
2:10 – 3:20 |
Compliance Case Study Workshop: Break-Out Session & Workshop Joseph Zimmerman  Margaret Sparks  Christie Camelio |
|
3:20 – 3:40 |
BREAK |
|
3:40 – 5:00 |
Compliance Officers Panel DiscussionMargaret Sparks  Jill Fallows Macaluso Joseph Zimmerman Christie Camelio Moderator: Jacob T. Elberg |
| Day4 - thursday, june 15, 2023 | |
|---|---|
Patient Interactions, Industry Guidance, Health Care Fraud Enforcement, and Investigations |
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|
8:30 – 9:00 a.m. |
REGISTRATION & BREAKFAST
|
|
9:00 – 10:20 |
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals Jeff Layne |
|
10:20 – 10:35 |
BREAK |
|
10:35 – 11:35 |
A Journey to the Dark Side of International Business: Real-World Risk and Real-World Lessons Richard Bistrong  Moderator: Jane Yoon |
|
11:45 – 12:45 |
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation Vikas Khanna |
|
12:45 – 1:45 |
LUNCH BREAK |
|
1:45 – 2:35 |
Before I Was a Compliance Officer ... Jim Sheehan |
|
2:40 – 4:00 |
Panel Discussion: Being the Focus of a Government InvestigationVikas Khanna Jane Yoon  John Kelly Jim Sheehan Moderator: Jacob Elberg |
|
4:00 - 4:15 |
CONCLUDING REMARKS
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