試験準備には欠かさない！RAC-US問題解答でRAC-US試験問題集
リアルRAPS RAC-US試験問題 [更新されたのは2022年]
質問 20
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. Quality and effectiveness
- D. Safety and effectiveness
正解: D
質問 21
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
- A. Fault tree analysis
- B. Fishbone analysis
- C. Quality by design analysis
- D. Failure modes, effects, and criticality analysis
正解: D
質問 22
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?
- A. The country's regulatory authority
- B. The ISO Secretariat
- C. The ISO national member body
- D. The ISO technical committee in charge of the area
正解: C
質問 23
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?
- A. Reformulate the products with a replacement material.
- B. Qualify another supplier and execute a supplier agreement.
- C. Complete a gap analysis to identify options.
- D. Review the company's existing Quality Management System
正解: B
質問 24
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. Import license
- D. Product license
正解: B
質問 25
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 26
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. Establish validation procedures.
- B. Review the stability data for the changes.
- C. Stop product manufacturing.
- D. Assess the impact of the changes.
正解: C
質問 27
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
- A. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
- B. Consult with colleagues about the request.
- C. Contact the regulatory authority that issued this request and discuss the requirement.
- D. Initiate testing immediately to ensure compliance.
正解: C
質問 28
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
- A. Terminate the PI and inform the regulatory authorities.
- B. Send a letter of complaint to the Ethics Committee that approved the site.
- C. Increase the frequency of monitoring visits.
- D. Inform the institution that granted a medical license to the Pi.
正解: A
質問 29
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Allow the auditor access to the room and records due to the current audit.
- B. Deny the auditor access to the room and records due to confidentiality concerns.
- C. Allow the auditor accompanied access to the room to retrieve the records.
- D. Deny the auditor access to the room and retrieve only the requested records.
正解: C
質問 30
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Develop documented procedures for regulatory compliance processes and train personnel.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Train all new employees on regulatory compliance processes and assign a mentor to them.
正解: A
質問 31
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?
- A. Deleting an ingredient of the drug product
- B. Introducing a new analytical method
- C. Strengthening a precaution to the product labeling
- D. Deleting a drug substance
正解: C
質問 32
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 33
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
- A. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
- B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
- C. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation - D. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
正解: C
質問 34
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. Confirm that the international monograph change is not related to local pharmacopeia.
- B. Prepare the international monograph change submission first and then prepare the local change when required.
- 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 35
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. Request a meeting with the regulatory authority to discuss the application.
- B. Review the regulatory guidelines to determine how to proceed.
- C. Consult with the legal department to discuss the best course of action.
- D. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
正解: A
質問 36
Which term does NOT describe the same concept as the others?
- A. Follow-on protein products
- B. Monoclonal antibody
- C. Biosimilars
- D. Subsequent entry biologics
正解: B
質問 37
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
- A. Product literature
- B. Essential principles
- C. Instructions for use
- D. Risk analysis
正解: D
質問 38
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?
- A. Certificate of Free Sale
- B. Certificate of GMP
- C. Certificate of Pharmaceutical Product
- D. Certificate of Analysis for the finished product
正解: C
質問 39
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through the industry representative
- B. Before the enactment of the regulation, through formal comments gathering process
- C. Before the enactment of the regulation, through the industry representative
- D. After the enactment of the regulation, through a product-specific meeting
正解: B
質問 40
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk reduction
- B. Risk evaluation
- C. Risk acceptance
- D. Risk analysis
正解: C
質問 41
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. Capacity of the manufacturing facilities to fully produce the new product
- B. Potential clinical sites for the Phase III clinical trial
- C. Previous actions taken by regulatory authorities on similar products
- D. Regulatory requirements for labeling and packaging
正解: C
質問 42
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