HMCC Speaker Bureau & Educational Programs 2

Question 1

Under AdvaMed's Code of Ethics, educational programs involving medical device speakers must primarily:

Accepted Answer

Serve a genuine educational function for healthcare professionals about relevant clinical topics

Answer

Feature speakers who exclusively use the sponsoring company's devices

Answer

Be limited to webinar formats to reduce hospitality costs

Answer

Require attendees to submit pre-authorization from their hospital administration

Question 2

When a company uses a third-party speaker bureau vendor, which compliance obligation remains with the manufacturer?

Accepted Answer

The manufacturer retains responsibility for ensuring vendor practices comply with applicable laws and company policies

Answer

All liability transfers entirely to the third-party vendor upon contracting

Answer

The manufacturer's only obligation is to pay the vendor's invoices on time

Answer

Compliance obligations are suspended while a third-party manages the bureau

Question 3

A pharmaceutical company's compliance officer discovers that a speaker program on the same drug was held six times in the same ZIP code within 90 days, with largely overlapping attendees. This pattern MOST likely indicates:

Accepted Answer

A potential Anti-Kickback Statute concern because programs may be functioning as sales calls with meals

Answer

Exceptional demand for disease-state education in that region

Answer

Full compliance since each program had a licensed physician speaker

Answer

Evidence that the local healthcare community is underserved in continuing education

Question 4

Under PhRMA guidelines, what is the meal limit standard for company-sponsored speaker programs?

Accepted Answer

Meals may be provided but must be modest and not the primary draw of the event

Answer

Meals are entirely prohibited at speaker programs

Answer

Meals may be lavish if the speaker is a Key Opinion Leader

Answer

Meals are unlimited provided attendees sign a conflict-of-interest disclosure

Question 5

What action should a compliance officer require when a company speaker makes unsolicited off-label statements during a sponsored program?

Accepted Answer

Immediately stop the program, document the incident, and report it through the company's adverse event and compliance reporting channels

Answer

Allow the statement to stand as it reflects the speaker's independent medical opinion

Answer

Instruct the sales representative present to note it in their CRM system only

Answer

Reimburse attendees for their time and cancel the program retroactively

Question 6

How should attendee lists from speaker programs be managed from a compliance perspective?

Accepted Answer

Lists should be retained securely and used only for legitimate compliance purposes such as Open Payments reporting and program audits

Answer

Lists should be shared freely with the sales force for follow-up calls

Answer

Lists are not required to be collected if the program has fewer than 10 attendees

Answer

Lists should be destroyed immediately after the program to protect attendee privacy

Question 7

Which of the following BEST describes a compliant speaker training program under PhRMA guidelines?

Accepted Answer

Training that equips speakers with accurate, balanced, and scientifically rigorous content about the disease state and product

Answer

Training focused primarily on how to increase prescriptions of the company's product

Answer

Training held at a luxury resort as a reward for the speaker's agreement to participate

Answer

Training that discourages speakers from discussing competitor products or clinical studies