最新なRAPS RAC-US問題集（100題）、真実試験の問題を全部にカバー！

質問 1：
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?
A. Correct the label text.
B. Delay the start of product production.
C. Abort the product launch.
D. Inform the regulatory authorities.
正解：D

質問 2：
In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?
A. Regulatory requirements for labeling and packaging
B. Potential clinical sites for the Phase III clinical trial
C. Previous actions taken by regulatory authorities on similar products
D. Capacity of the manufacturing facilities to fully produce the new product
正解：C

質問 3：
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
A. Safety and failure risk
B. Quality and failure risk
C. Safety and effectiveness
D. Quality and effectiveness
正解：C

質問 4：
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

質問 5：
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. Prepare the international monograph change submission first and then prepare the local change when required.
B. Confirm that the international monograph change is not related to local pharmacopeia.
C. Analyze the impact of the international monograph change on the local pharmacopeia.
D. Transfer the notice of the upcoming international monograph change to QA for further processing.
正解：D

質問 6：
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. Prepare the legal team in Country Y for possible litigations.
B. Review alt distribution records and complaints reported in Country Y.
C. Initiate a mandatory recall of the product in Country Y.
D. Draft a formal letter to customers in Country Y about this recall.
正解：B

質問 7：
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
A. Efficacy and material
B. Volume and material
C. Compatibility and safety
D. Safety and efficacy
正解：C

質問 8：
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. ISO 14971 risk analysis
B. Failure mode and effect analysis
C. Hazard and operability study
D. Fault tree analysis
正解：A

質問 9：
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. Explore litigation strategy for patent infringements on 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. Develop a generic version of the drug.
正解：D