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無料RAPS RAC-USテスト練習問題試験問題集
質問 # 53
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. Draft a formal letter to customers in Country Y about this recall.
- B. Prepare the legal team in Country Y for possible litigations.
- C. Initiate a mandatory recall of the product in Country Y.
- D. Review alt distribution records and complaints reported in Country Y.
正解：D
質問 # 54
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I and II clinical trials
- C. Phase I clinical trials
- D. Phase III clinical trials
正解：D
質問 # 55
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- B. Ask that the regulatory authority provide the actual product subject to the complaint.
- C. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release. - D. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
正解：A
質問 # 56
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- B. Perform either an identification study or a non-clinical qualification study.
- C. Perform both identification and non-clinical qualification studies concurrently.
- D. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
正解：D
質問 # 57
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?
- A. Analytical
- B. Regulatory
- C. Quality
- D. Production
正解：C
質問 # 58
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
- A. 0
- B. 1
- C. 2
- D. 3
正解：D
質問 # 59
Which of the following claims would classify an apple as a drug?
- A. "It will whiten teeth."
- B. "It will make you look younger."
- C. "It will satisfy hunger."
- D. "It will prevent colds."
正解：D
質問 # 60
An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?
- A. Review the stability data for the changes.
- B. Stop product manufacturing.
- C. Assess the impact of the changes.
- D. Establish validation procedures.
正解：B
質問 # 61
A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
- A. Promote off-label use to a carefully selected patient population.
- B. Label the product for use in appropriate populations.
- C. Educate patients and healthcare providers on how to use the product
- D. Delay product launch until required studies are completed.
正解：A
質問 # 62
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Train employees on all regulatory compliance processes using state-of-the-art systems.
- B. Develop documented procedures for regulatory compliance processes and train personnel.
- C. Train all new employees on regulatory compliance processes and assign a mentor to them.
- D. Document any failure to follow regulatory compliance processes in employee performance reviews.
正解：B
質問 # 63
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
- A. Marketing materials
- B. Safety issues
- C. Intellectual properly
- D. Clinical trial data
正解：B
質問 # 64
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?
- A. Three years after the last clinical study site was supplied with investigational drugs
- B. For a minimum of 10 years after completion of the clinical study
- C. Until the product has been discontinued from marketing in all ICH regions
- D. For at least two years after the last approval of an application in an ICH region
正解：D
質問 # 65
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
- A. Fishbone analysis
- B. Failure modes, effects, and criticality analysis
- C. Fault tree analysis
- D. Quality by design analysis
正解：B
質問 # 66
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Request a permanent waiver from the new regulation.
- B. Contact the trade association for advice.
- C. Prepare documents for the files.
- D. Communicate with the relevant internal departments.
正解：D
質問 # 67
Which of the following is NOT required to be included in a marketing application?
- A. Final printed label
- B. Evidence of fee payment
- C. Quality, safety, and efficacy Information
- D. Administrative forms
正解：B
質問 # 68
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Export license
- B. Site license
- C. Product license
- D. Import license
正解：B
質問 # 69
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Review the regulatory guidelines to determine how to proceed.
- B. Consult with the legal department to discuss the best course of action.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- D. Request a meeting with the regulatory authority to discuss the application.
正解：D
質問 # 70
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Arrange for additional testing of the product at the testing facility.
- B. Consult with the company's legal department regarding options.
- C. Inform the company's senior management and arrange an emergency meeting
- D. Obtain a copy of the proposed regulation and analyze the impact.
正解：D
質問 # 71
According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?
- A. 30 C and 35% RH
- B. 30c C and 65% RH
- C. 25: C and 60% RH
- D. 30: C and 75% RH
正解：D
質問 # 72
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. File patents of interest in target countries.
- B. File design patents in target countries.
- C. Use the Madrid system.
- D. Use the community patent system.
正解：A
質問 # 73
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
- A. 0
- B. 1
- C. 2
- D. 3
正解：C
質問 # 74
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Regulatory Affairs Certification（RAC）は、医療機器、医薬品、およびバイオロジック分野で働く規制専門家向けのプロフェッショナル資格です。RAC認証は、Regulatory Affairs Professionals Society（RAPS）によって提供されています。 RAPS RAC-US試験は、アメリカの規制関連の専門家の知識と理解を評価する認定試験です。
RAC-US試験を受験するには、候補者は特定の教育と経験要件を満たす必要があります。この試験は、春、夏、秋の3回開催されます。候補者は、RAC学習資料を学習したり、RAPS教育コースに参加したり、RAPSの会議やイベントに参加することで試験の準備ができます。
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