リアルRAPS RAC-US試験問題 [更新されたのは2023年]
RAC-US試験問題集で合格させるのは更新されたのは2023年年最新のRegulatory Affairs Certification (RAC) US
RAPS RAC-US認定試験は、規制戦略、製品開発、臨床試験、ラベル付けと広告、市場後の監視、国際規制など、規制業務に関連する幅広いトピックをカバーしています。この試験は包括的であるように設計されており、RAPS RAC-US試験の青写真に基づいており、認定に必要な知識とスキルの概要を説明しています。
質問 # 46
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?
- A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
- B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
- C. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
- D. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
正解：A
質問 # 47
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. Wait for the regulatory authority's final publication on its findings.
- B. Contact the regulatory authority to discuss its findings.
- C. Contact the regulatory authority to argue that its conclusions are wrong.
- D. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
正解：B
質問 # 48
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 3
- B. Module 2
- C. Module 4
- D. Module 1
正解：B
質問 # 49
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 regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
- C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
- D. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
正解：D
質問 # 50
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. Delay product launch until required studies are completed.
- C. Educate patients and healthcare providers on how to use the product
- D. Label the product for use in appropriate populations.
正解：A
質問 # 51
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Safety and efficacy
- B. Compatibility and safety
- C. Volume and material
- D. Efficacy and material
正解：B
質問 # 52
Which of the following is the PRIMARY purpose of an audit report?
- A. To document compliance history
- B. To define how to prepare new product submissions
- C. To carry out a complete review of product applications
- D. To train sales representatives
正解：A
質問 # 53
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. Use the community patent system.
- D. File patents of interest in target countries.
正解：D
質問 # 54
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
- A. Deficiency of a device found by the user prior to patient use
- B. Malfunction occurring before the end of service life of the medical device
- C. Adverse event caused by patient conditions
- D. Malfunction protection operated correctly
正解：C
質問 # 55
A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?
- A. Labeling
- B. Risk management process
- C. Safety-related reporting
- D. Regulatory application summary
正解：A
質問 # 56
Which of the following is NOT required to be included in a marketing application?
- A. Administrative forms
- B. Quality, safety, and efficacy Information
- C. Final printed label
- D. Evidence of fee payment
正解：D
質問 # 57
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?
- A. Resubmit the entire package.
- B. Inform upper management immediately.
- C. Verify the procedure in the regulation for the corrections.
- D. Contact the legal department and ask them how to proceed.
正解：C
質問 # 58
The requirements for document control are located in which of the following documents?
- A. ISO 13485
- B. IEC 60601
- C. WHO guidelines
- D. ICH guidelines
正解：A
質問 # 59
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?
- A. Identify countries where special requirements exist during the product development phase.
- B. Utilize the STED template to complete global requirements.
- C. Plan regulatory approval update meetings with senior management and stakeholders.
- D. Initiate a global submission process after all submission data are finalized.
正解：A
質問 # 60
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Import license
- B. Product license
- C. Site license
- D. Export license
正解：C
質問 # 61
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 actual product subject to the complaint.
- B. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
- 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：B
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. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train all new employees on regulatory compliance processes and assign a mentor to them.
正解：C
質問 # 63
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. Discontinue the project.
- B. Redesign the device.
- C. Add a warning in the IFU.
- D. Perform another risk-benefit analysis.
正解：B
質問 # 64
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：C
質問 # 65
Which of the following claims would classify an apple as a drug?
- A. "It will make you look younger."
- B. "It will prevent colds."
- C. "It will whiten teeth."
- D. "It will satisfy hunger."
正解：B
質問 # 66
A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?
- A. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
- B. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
- C. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
- D. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
正解：B
質問 # 67
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