RAC-US試験無料問題集（100題）「RAPS Regulatory Affairs Certification (RAC) US 認定」

出題：1

A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A. Early technical design and product release

B. Concept development and validation

C. Product release and validation

D. Concept development and early technical design

正解：D 解答を投票する

出題：2

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

A. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions

B. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

C. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions

D. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions

正解：B 解答を投票する

出題：3

A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

A. Adverse event reports

B. Clinical investigations

C. Literature search

D. Clinical experience

正解：B 解答を投票する

出題：4

GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

A. Product literature

B. Risk analysis

C. Essential principles

D. Instructions for use

正解：B 解答を投票する

出題：5

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A. The process information and analytical result of Company Y API

B. The process information and the comparative analytical result of APIs from both companies

C. The process information and analytical result of Company X API

D. Information deemed appropriate by the regulatory authority

正解：B 解答を投票する

出題：6

According to ICH, which of the following components of study information is NOT required in a clinical study report?

A. List of lECs or lRBs

B. Detailed CV of all investigators

C. Protocol and protocol amendments

D. Randomization scheme and codes

正解：B 解答を投票する

出題：7

Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

A. Develop a better brand-name drug in the same class.

B. Explore litigation strategy for patent infringements on the drug.

C. Develop a generic version of the drug.

D. Conduct a Phase III study for a new unrelated indication of the drug.

正解：C 解答を投票する

出題：8

Which term does NOT describe the same concept as the others?

A. Subsequent entry biologics

B. Follow-on protein products

C. Biosimilars

D. Monoclonal antibody

正解：D 解答を投票する

出題：9

A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

A. Scope and level of detail

B. Expiration date

C. Revision history

D. Relevance to regulations

正解：D 解答を投票する

出題：10

A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?

A. Review the content of change and supporting data for the equivalency with the current material.

B. No action is needed in this situation.

C. Write a memo to file since the change does not impact product safety and effectiveness.

D. Prepare regulatory submissions that detail the medical device's change in materials.

正解：A 解答を投票する

RAC-US試験無料問題集「RAPS Regulatory Affairs Certification (RAC) US 認定」