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Chapter 22: Pharmaceutical Industry and Regulatory Affairs

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

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a. Regulatory Affairs

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b. Publications

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c. Market Research

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d. Medical Information

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e. Outcomes Research

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c. Market Research

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

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a. Standard response letter

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b. Study publication

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c. Competitor package insert

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d. Online drug information website

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e. Social media websites

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a. Standard response letter

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What can studies created by the Outcomes Research department evaluate?

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a. Health care utilization

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b. Patient adherence and compliance

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c. Efficacy of product

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d. a and b

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e. b and c

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d. a and b

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

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a. Medical Publications

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b. Marketing

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c. Medical Information

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d. Metrics

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e. Marketing

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c. Medical Information

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

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a. Externally by Food and Drug Administration

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b. Externally by Food and Drug Administration Amendments Act

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c. Internally by standard operating procedures

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d. Externally by the Code of Federal Regulations

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e. All of the above

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e. All of the above

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

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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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