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

質問 1：
A global company has obtained a patent in a specific country for a newly marketed product. What would be the BEST advice In order to protect the patent in other countries?
A. Use the Madrid system.
B. File design patents in target countries.
C. File patents of interest in target countries.
D. Use the community patent system.
正解：C

質問 2：
Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?
A. Enter into an agreement with Company Y to perform due diligence.
B. Perform a thorough library search to gather detailed information on Company Y.
C. Recruit a professional to gather confidential intelligence on Company Y.
D. Request the needed information from the Board of Directors of Company Y.
正解：A

質問 3：
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?
A. Written procedure for product traceability
B. Service operation procedures
C. Local reimbursement requirements
D. Training program for sales people
正解：D

質問 4：
One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?
A. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
B. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
C. "We have no additional informationto provide at this time, but wecan perform an additional analysis for a specific safety concern, if necessary."
D. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
正解：C

質問 5：
The safety database for an anti-hypertensive drug consists of the following:
461 patients exposed for three months
343 patients exposed for six months
112 patients exposed for nine months
74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
A. 3.000 total patient exposures
B. 100 patients for 12 months
C. 500 patients for three months
D. 200 patients for nine months
正解：B

質問 6：
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 7：
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?
A. Inform the production team.
B. Compare the approved text with the product label
C. Notify the regulatory authority.
D. Recommend an immediate product recall.
正解：B

質問 8：
Which of the following BEST describes the purpose of the ICH?
A. To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions
B. To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions
C. To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions
D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
正解：D