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

AdvaMed's Code requires that all educational programs serve a legitimate educational purpose for healthcare professionals and are not designed primarily as a reward or inducement.

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

Outsourcing to a third-party bureau does not transfer the manufacturer's legal and ethical compliance obligations; due diligence, oversight, and ultimate accountability remain with the company.

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

Repeated programs in tight geographies with repeat attendees indicate the educational need has been met and additional programs may be a pretext for providing meals or remuneration, raising Anti-Kickback Statute concerns.

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

PhRMA guidelines permit modest meals that are incidental to the educational program, but prohibit extravagant meals or entertainment that could be viewed as the real incentive for attendance.

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

Off-label promotion at a sponsored program creates regulatory risk; the company must stop the off-label communication, document the incident, and escalate through compliance and potentially FDA reporting channels.

HMCC - Healthcare Meeting Compliance Certificate Practice Test

HMCC - Healthcare Meeting Compliance Certificate Practice Test

HMCC Speaker Bureau & Educational Programs 2