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Chapter 22: Pharmaceutical Industry and Regulatory Affairs

Which of the following is NOT a department within the medical department of a company that employs HPs?

a. Regulatory Affairs

b. Publications

c. Market Research

d. Medical Information

e. Outcomes Research

c. Market Research

What resources can a customer service representative in the pharmaceutical industry utilize to respond to customer inquiries?

a. Standard response letter

b. Study publication

c. Competitor package insert

d. Online drug information website

e. Social media websites

a. Standard response letter

What can studies created by the Outcomes Research department evaluate?

a. Health care utilization

b. Patient adherence and compliance

c. Efficacy of product

d. a and b

e. b and c

d. a and b

Which of the following departments may be involved in approving a standard response letter?

a. Medical Publications

b. Marketing

c. Medical Information

d. Metrics

e. Marketing

c. Medical Information

HPs are regulated in industry in which of the following ways?

a. Externally by Food and Drug Administration

b. Externally by Food and Drug Administration Amendments Act

c. Internally by standard operating procedures

d. Externally by the Code of Federal Regulations

e. All of the above

e. All of the above

Identify which interaction between pharmaceutical industry and HPs is unacceptable according to PhRMA's Code on Interactions with Health Care Professionals.

a. An industry representative stops by a clinician's office to invite them to an upcoming industry-sponsored continuing medical education event.

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