QUESTION: 25

Which of the following BEST describes the purpose of the ICH?

To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions
To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions
To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

Answer(s): D

Company X is planning to acquire the rights for a product marketed by Company Y. As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

Intellectual properly
Clinical trial data
Safety issues
Marketing materials

Answer(s): C

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QUESTION: 27

A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?

Review the company's existing Quality ManagementSystem
Reformulate the products with a replacement material.
Qualify another supplier and execute a supplier agreement.
Complete a gap analysis to identify options.

Answer(s): C,D

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QUESTION: 28

Which of the following is the PRIMARY purpose of an audit report?

To carry out a complete review of product applications
To define how to prepare new product submissions
Todocument compliance history
To train sales representatives

Answer(s): C

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QUESTION: 25

QUESTION: 26

QUESTION: 27

QUESTION: 28

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