RAC-USの無料問題集（100題）、RAC-US認定試験参考書

RAPS RAC-US 問題集

試験コード：RAC-US

試験名称：Regulatory Affairs Certification (RAC) US

最近更新時間：2024-11-17

問題と解答：全100問

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質問 1：
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. Potential clinical sites for the Phase III clinical trial
B. Capacity of the manufacturing facilities to fully produce the new product
C. Previous actions taken by regulatory authorities on similar products
D. Regulatory requirements for labeling and packaging
正解：C

質問 2：
Which of the following is MOST appropriate for the purpose of lot release of biologics?
A. Quality verification
B. Efficacy confirmation
C. Safety assurance
D. Inventory control
正解：A

質問 3：
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. Assess the impact of the changes.
B. Establish validation procedures.
C. Stop product manufacturing.
D. Review the stability data for the changes.
正解：C

質問 4：
According to ICH, which of the following components of study information is NOT required in a clinical study report?
A. List of lECs or lRBs
B. Protocol and protocol amendments
C. Detailed CV of all investigators
D. Randomization scheme and codes
正解：C

質問 5：
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
A. Government survey data indicate the product is superior.
B. In vitro studies show the product to be superior.
C. Results of adequate, well-controlled comparative clinical trial show the product is superior.
D. Results of a three-year, post-market patient survey indicate the product is superior.
正解：C

質問 6：
The requirements for document control are located in which of the following documents?
A. WHO guidelines
B. ISO 13485
C. IEC 60601
D. ICH guidelines
正解：B

質問 7：
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
A. Systematic procedure to review published scientific journals
B. Vigilance procedure to ensure the full traceability of the products
C. Systematic procedure to review experiences with the products in use
D. Vigilance procedure to notify the regulatory authorities about serious incidents
正解：B

質問 8：
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

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RAPS Regulatory Affairs Certification (RAC) US 認定 RAC-US 試験問題:

1. At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

A) Acknowledge receipt of the letter in a written response but do nothing further.
B) Inform the local regulatory authority of the letter and discuss how to respond.
C) Inform the legal department of the letter and discuss how to respond.
D) Inform Company X that it has no right to send such a letter and do nothing further.

2. Which of the following is NOT required to be included in a marketing application?

A) Evidence of fee payment
B) Administrative forms
C) Quality, safety, and efficacy Information
D) Final printed label

3. Which of the following BEST describes the purpose of the ICH?

A) To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
B) To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
C) To lobby for improved industry standards for the development of new safe, 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

4. 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) Inform the company's senior management and arrange an emergency meeting
C) Consult with the company's legal department regarding options.
D) Obtain a copy of the proposed regulation and analyze the impact.

5. 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) Educate patients and healthcare providers on how to use the product
B) Promote off-label use to a carefully selected patient population.
C) Delay product launch until required studies are completed.
D) Label the product for use in appropriate populations.

質問と回答：

質問 # 1
正解： C

質問 # 2
正解： A

質問 # 3
正解： D

質問 # 4
正解： D

質問 # 5
正解： B