RAC-GS無料問題集「RAPS Regulatory Affairs Certification (RAC) Global Scope」

質問 1

In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

（A）Safety and efficacy

（B）Efficacy and material

（C）Volume and material

（D）Compatibility and safety

正解：D 解答を投票する

質問 2

During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

（A）Terminate the PI and inform the regulatory authorities.

（B）Inform the institution that granted a medical license to the Pi.

（C）Increase the frequency of monitoring visits.

（D）Send a letter of complaint to the Ethics Committee that approved the site.

正解：A 解答を投票する

質問 3

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）Information deemed appropriate by the regulatory authority

（B）The process information and analytical result of Company X API

（C）The process information and analytical result of Company Y API

（D）The process information and the comparative analytical result of APIs from both companies

正解：D 解答を投票する

質問 4

The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

（A）Confirm that the international monograph change is not related to local pharmacopeia.

（B）Analyze the impact of the international monograph change on the local pharmacopeia.

（C）Prepare the international monograph change submission first and then prepare the local change when required.

（D）Transfer the notice of the upcoming international monograph change to QA for further processing.

正解：C、D 解答を投票する

質問 5

During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

（A）Failure mode and effect analysis

（B）Fault tree analysis

（C）Hazard and operability study

（D）ISO 14971 risk analysis

正解：D 解答を投票する

質問 6

A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?

（A）Ask the trade association representative to provide an overview of the new product area to the marketing team.

（B）Obtain competitor research and provide the information to the management team.

（C）Summarize regulatory documents and history and provide the information to the management team.

（D）Obtain regulatory documents and history and provide the information to R&D.

正解：C 解答を投票する

質問 7

A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?

（A）Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

（B）Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

（C）Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

（D）Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

正解：D 解答を投票する

質問 8

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 generic version of the drug.

（B）Develop a better brand-name drug in the same class.

（C）Conduct a Phase III study for a new unrelated indication of the drug.

（D）Explore litigation strategy for patent infringements on the drug.

正解：A 解答を投票する

質問 9

The requirements for document control are located in which of the following documents?

（A）ISO 13485

（B）ICH guidelines

（C）WHO guidelines

（D）IEC 60601

正解：A 解答を投票する

質問 10

A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

（A）Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.

（B）Contact the regulatory authority that issued this request and discuss the requirement.

（C）Initiate testing immediately to ensure compliance.

（D）Consult with colleagues about the request.

正解：B 解答を投票する

RAC-GS 無料問題集「RAPS Regulatory Affairs Certification (RAC) Global Scope」

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