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 | |
|---|---|
Ethics, Transparency, Privacy, Federal Health Care Programs, and Government Pricing |
|
|
8:45 a.m. |
REGISTRATION OPENS
|
|
9:00 – 9:45 |
Welcome, Program Introduction & Format Review Rosa Alves  Jacob Elberg |
|
9:50 – 10:45 |
The Relationship Between Ethics and Legal ComplianceJacob 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
|
|
4:00 – 5:00 |
Government Pricing Regulation: Key Issues for Compliance Professionals Kathleen Peterson |
| Day2 | |
|---|---|
False Claims Act, Anti-Kickback Statute, FDA Regulation, Foreign Corrupt Practices Act, and Speaker Programs |
|
|
8:45 a.m. |
REGISTRATION
|
|
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
|
|
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
|
|
4:05 – 5:10 |
Track 1: FDA Regulation of Drug Development & Approval Julia Post
|
|
5:15 – 6:00 |
VIRTUAL NETWORKING RECEPTION
|
| Day3 | |
|---|---|
Advertising & Promotion, Data Analytics, Corporate Integrity Agreements, Case Study, and Compliance Officers' Panel |
|
|
8:45 a.m. |
REGISTRATION
|
|
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 DiscussionMargaret Sparks Jennifer McGee Regina Gore Cavaliere  Michael (Mickey) Kim Jill Fallows Macaluso Joe Zimmerman  Moderator: Kathleen Boozang |
| Day4 | |
|---|---|
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
|
|
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 InvestigationLee Cortes  Laurie Allen Jane Yoon Jim Sheehan  John Kelly Moderator: Jacob Elberg |
|
3:45 |
CONCLUDING REMARKS
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