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NEW QUESTION 28
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

• A. Inform the legal department of the letter and discuss how to respond.
• B. Inform the local regulatory authority of the letter and discuss how to respond.
• C. Acknowledge receipt of the letter in a written response but do nothing further.
• D. Inform Company X that it has no right to send such a letter and do nothing further.

Answer: A

NEW QUESTION 29
A process is ultimately validated to ensure which of the following?

• A. The process consistently meets the desired Quantity standards
• B. The process consistently produces the desired results.
• C. The process meets the regulatory requirements.
• D. The process meets the quality system requirements.

Answer: B

NEW QUESTION 30
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

• A. 0
• B. 1
• C. 2
• D. 3

Answer: C

NEW QUESTION 31
Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?

• A. Cross-over
• B. Placebo-controlled
• C. Active-controlled
• D. Dose-ranging

Answer: A

NEW QUESTION 32
Which of the following is the PRIMARY purpose of an audit report?

• A. To carry out a complete review of product applications
• B. To train sales representatives
• C. To define how to prepare new product submissions
• D. To document compliance history

Answer: D

NEW QUESTION 33
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