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 2024 (dates TBD) | Virtual
Agenda Below - All Times in Eastern Standard Time
| Day 1 | |
|---|---|
Ethics, Transparency, Federal Health Care Programs, FDA Regulation, and Government Pricing |
|
|
8:45 - 9:00 |
REGISTRATION
|
|
9:00 – 9:20 |
Welcome, Program & Format Review Rosa M. Alves  Timothy Glynn |
|
9:25 – 9:50 |
Introductions & IcebreakerRosa M. Alves Timothy Glynn |
|
9:55 – 10:45 |
The Relationship Between Ethics and Legal ComplianceTimothy Glynn |
|
10:45 – 11:00 |
BREAK
|
|
11:00 – 12:20 |
Navigating Global Transparency Disclosure Requirements Keren F. Bisnauth |
|
12:20 – 1:20 |
LUNCH BREAK |
|
1:20 – 2:25 |
An Overview of Federal and Private Health Care Programs for Drug and Device Manufacturers Philo D. Hall |
|
2:30 – 3:40 |
Government Pricing Regulation: Key Issues for Compliance Professionals Kathleen Peterson |
|
3:40 – 3:55 |
BREAK
|
|
3:55 – 5:05 |
Track 1: FDA Regulation of Drug Development & Approval Julia Post
|
| Day 2 | |
|---|---|
False Claims Act, Anti-Kickback Statute, Foreign Corrupt Practices Act, Advertising & Promotion, and Speaker Programs |
|
|
8:45 |
REGISTRATION
|
|
9:00 – 10:15 |
The False Claims Act and Dealing with Whistleblowers Meredith Auten  Gregg Shapiro |
|
10:15 – 10:30 |
BREAK
|
|
10:30 – 11:45 |
The Federal Anti-Kickback Statute Bruce Levy |
|
11:45 – 12:45 |
LUNCH BREAK |
|
12:45 – 2:05 |
The Foreign Corrupt Practices Act (and World-Wide Anti-Corruption Enforcement) Gary Giampetruzzi  Piyush Sharma |
|
2:10 – 3:35 |
Prescription Drug & Medical Device Advertising/Scientific & Educational Activities Gillian M. Russell  Nikki Reeves |
|
3:35 – 3:50 |
BREAK
|
|
3:50 – 4:40 |
Compliance Risks Associated with Speaker Programs Craig Carpenito  Adam Baker |
|
4:45 – 5:30 |
VIRTUAL NETWORKING RECEPTION
|
| Day 3 | |
|---|---|
Privacy, Data Analytics, Corporate Integrity Agreements, Case Study, and Compliance Officers' Panel |
|
|
8:45 |
REGISTRATION
|
|
9:00 – 10:20 |
Topics in U.S. Privacy and Data Protection: Pharmaceutical and Biotech Considerations Jeremy Berkowitz |
|
10:20 – 10:35 |
NETWORKING BREAK |
|
10:35 – 11:35 |
Compliance Lessons Learned from Corporate Integrity Agreements Seth Lundy |
|
12:45 – 1:45 |
LUNCH BREAK |
|
1:45 – 2:45 |
Data Analytics Stacy Aiken  Anna Loveless  Michael Driscoll  Jacob T. Elberg |
|
2:50 – 4:00 |
Compliance Case Study Workshop: Break-Out Session & Workshop Joseph Zimmerman  Jennifer McGee  Christie Camelio  Paul Curtin  Sujata Dayal |
|
4:00 – 4:15 |
BREAK |
|
4:15 – 5:30 |
Compliance Officers Panel DiscussionJoseph Zimmerman Jennifer McGee Christie Camelio Paul Curtin  Michael "Mickey" Kim Sujata Dayal Moderator: Jacob T. Elberg |
| Day 4 | |
|---|---|
Patient Interactions, Diversity, Equity & Inclusion, Health Care Fraud Enforcement, and Investigations |
|
|
8:45 |
REGISTRATION
|
|
9:00 – 10:10 |
AdvaMed v. PhRMA: Comparing Codes of Ethics on Interactions with Health Care Professionals Jeff Layne |
|
10:10 – 10:30 |
BREAK |
|
10:30 – 11:30 |
Diversity, Equity and Inclusion in the Compliance Industry Nicole Stovall  Alison Hinds-Pearl Sujata Dayal Moderator: Jacob Elberg |
|
11:35 – 12:35 |
Recent Developments in Federal Healthcare Fraud Prosecution and the Value of Compliance and Cooperation Vikas Khanna |
|
12:35 – 1:35 |
LUNCH BREAK |
|
1:35 – 2:45 |
Panel Discussion: Being the Focus of a Government InvestigationVikas Khanna  Jane Yoon  John Kelly  Jim Sheehan  Bruce Wayne Moderator: Jacob Elberg |
|
2:50 – 3:40 |
Before I Was a Compliance Officer ...Jim Sheehan |
|
3:45 - 4:00 |
CONCLUDING REMARKS
|