Healthcare Compliance Training - Program Schedule
U.S. Healthcare Compliance Certificate Program
[email protected] | 973-642-8871 or 973-761-9000 ext. 8871
PROGRAM SCHEDULED for June 13-16, 2022 | Hyflex (In-person + Virtual)
Note: Agenda available below (in Eastern Time).
| Day1 Monday, October 11, 2021 | |
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ETHICS, TRANSPARENCY, PRIVACY, FEDERAL HEALTH CARE PROGRAMS, AND GOVERNMENT PRICING |
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9:00 a.m. |
Registration Opens
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9:30 – 10:10 |
Welcome, Program Overview, Introductions
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10:15 – 11:10 |
The Relationship Between Ethics and Legal Compliance Jacob Elberg |
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11:15 – 12:20 |
Navigating State, Federal & International Transparency Disclosure Requirements
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12:20 – 1:25 |
BREAK |
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1:25 – 2:40 |
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations
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2:45 – 3:50 |
An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers
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3:50 – 4:05 |
BREAK
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11:15 – 12:25 |
The Federal Anti-Kickback Statute Marc Larkins  Bruce A. Levy |
| Day2 Tuesday, October 12, 2021 | |
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FALSE CLAIMS ACT, ANTI-KICKBACK STATUTE, FDA REGULATION, AND FOREIGN CORRUPT PRACTICES ACT |
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10:00 – 11:10 |
The False Claims Act and Dealing with Whistleblowers Meredith Auten  Pamela Coyle Brecht |
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11:15 – 12:15 |
Government Pricing Regulation: Key Issues for Compliance Professionals
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12:25 – 1:30 |
LUNCH BREAK & Discussion on Health Care Fraud Enforcement in Changing Administrations  Craig Carpenito |
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1:30 – 2:35 |
Track 1: FDA Regulation of Drug Development & Approval
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2:35 – 3:30 |
A Journey to the Dark Side of International Business: Real-World Risk and Real-World Lessons
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3:30 – 3:45 |
BREAK
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3:50 – 5:00 |
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement)
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| Day3 Wednesday, October 13, 2021 | |
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ADVERTISING & PROMOTION, PATIENT INTERACTIONS, DATA ANALYTICS, CASE STUDY, AND COMPLIANCE OFFICERS’ PANEL |
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10:00– 11:05 |
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities
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11:10 – 12:00 |
Compliance Considerations in the New Age of Patient Advocacy Liz Lewis Jacob Elberg |
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12:20 – 1:05 |
BREAK |
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1:05 – 2:10 |
Data Analytics
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2:10 – 2:25 |
BREAK |
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2:25 – 3:55 |
Compliance Case Study Workshop
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4:00 – 5:10 |
Compliance Officers Panel Discussion
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5:10 – 6:00 |
VIRTUAL NETWORKING
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| Day4Thursday, October 14, 2021 | |
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CORPORATE INTEGRITY AGREEMENTS, INDUSTRY GUIDANCE, HEALTH CARE FRAUD ENFORCEMENT, AND INVESTIGATIONS |
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10:00– 11:00 |
Compliance Lessons Learned from Corporate Integrity Agreements
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11:05 – 12:05 |
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals Jeff Layne |
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12:05 – 1:05 |
BREAK |
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1:05 – 2:05 |
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation
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2:10 – 3:00 |
Before I Was a Compliance Officer
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3:00 – 3:15 |
BREAK |
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3:15 – 4:30 |
Panel Discussion: Being the Focus of a Government Investigation
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4:30 –4:45 |
CONCLUDING REMARKS
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