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

質問 1

After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

（A）Add a warning in the IFU.

（B）Redesign the device.

（C）Discontinue the project.

（D）Perform another risk-benefit analysis.

正解：B 解答を投票する

質問 2

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

質問 3

The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

（A）Initiate a mandatory recall of the product in Country Y.

（B）Prepare the legal team in Country Y for possible litigations.

（C）Draft a formal letter to customers in Country Y about this recall.

（D）Review alt distribution records and complaints reported in Country Y.

正解：D 解答を投票する

質問 4

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

（A）"Is the product better than currently available alternatives?"

（B）"Is the product an established gold standard?"

（C）"Has the product been approved for mor&4nan 10 years?"

（D）"Is the product profitable for the manufacturer?"

正解：A 解答を投票する

質問 5

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）Concept development and validation

（B）Concept development and early technical design

（C）Early technical design and product release

（D）Product release and validation

正解：B 解答を投票する

質問 6

Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

（A）Proposed dose and volume of administration

（B）Immunochemical and functional tests

（C）Biological activity with species and/or tissue specificity

（D）Proposed product route and frequency of administration

正解：C 解答を投票する

質問 7

According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

（A）30c C and 65% RH

（B）25: C and 60% RH

（C）30: C and 75% RH

（D）30 C and 35% RH

正解：C 解答を投票する

質問 8

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 9

During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?

（A）Contact the regulatory authority to argue that its conclusions are wrong.

（B）Repeat the Hepatotoxicity tests and send the results to the regulatory authority.

（C）Wait for the regulatory authority's final publication on its findings.

（D）Contact the regulatory authority to discuss its findings.

正解：D 解答を投票する

質問 10

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

（A）Biosimilars

（B）Follow-on protein products

（C）Subsequent entry biologics

（D）Monoclonal antibody

正解：D 解答を投票する

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

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