2026年最新のお手軽に合格させるRAC-GS試験にはこちらが提供する問題集PDFテストエンジン
RAC-GSのPDFで合格させるスゴ問題集でRAC-GS最新のリアル試験問題
質問 # 15
During the review of a design dossier, the reviewer asks why the company has only carried out a
top-down risk approach. The reviewer is referring to which of the following?
- A. Fault tree analysis
- B. Failure mode and effect analysis
- C. Hazard and operability study
- D. ISO 14971 risk analysis
正解：D
質問 # 16
Which term does NOT describe the same concept as the others?
- A. Biosimilars
- B. Follow-on protein products
- C. Subsequent entry biologics
- D. Monoclonal antibody
正解：D
質問 # 17
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. As many as government attendees
- B. The minimum number of attendees necessary to address the issues
- C. As many as required by international standards
- D. All senior management from the main office
正解：B
質問 # 18
A process is ultimately validated to ensure which of the following?
- A. The process meets the regulatory requirements.
- B. The process consistently produces the desired results.
- C. The process consistently meets the desired Quantity standards
- D. The process meets the quality system requirements.
正解：B
質問 # 19
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. Clinical trial data
- B. Safety issues
- C. Intellectual properly
- D. Marketing materials
正解：B
質問 # 20
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
- A. Product license
- B. Site license
- C. Import license
- D. Export license
正解：B
質問 # 21
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. Stop product manufacturing.
- B. Assess the impact of the changes.
- C. Establish validation procedures.
- D. Review the stability data for the changes.
正解：A
質問 # 22
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?
- A. Training program for sales people
- B. Service operation procedures .
- C. Written procedure for product traceability
- D. Local reimbursement requirements
正解：A
質問 # 23
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and
include instances of complete remission. The company has been granted patents in multiple countries for
the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential
problems for marketing of the product worldwide. Which of the following is the MOST important
consideration to discuss?
- A. The stability of the drug in all zone conditions
- B. International import and export regulations
- C. The time frame in which the patent will expire
- D. Doha Declaration in the TRIPS Agreement
正解：A
質問 # 24
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. Request additional resources from senior management in order to complete the labeling conversion
within the time frame given by the regulatory authority. - B. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority
requirement and assign responsibilities. - C. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period
from the regulatory authority. - D. Submit as many labeling conversion applications as possible within the time frame and request an
extension for the remaining ones.
正解：C
質問 # 25
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. Deny the auditor access to the room and retrieve only the requested records.
- B. Allow the auditor access to the room and records due to the current audit.
- C. Allow the auditor accompanied access to the room to retrieve the records.
- D. Deny the auditor access to the room and records due to confidentiality concerns.
正解：C
質問 # 26
A company is developing a new medical device. During which initial stage is it MOST appropriate (or a
regulatory affairs professional to become involved?
- A. Concept development and early technical design
- B. Product release and validation
- C. Early technical design and product release
- D. Concept development and validation
正解：A
質問 # 27
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - B. Obtain regulatory documents and history and provide the information to R&D.
- C. Summarize regulatory documents and history and provide the information to the management team.
- D. Obtain competitor research and provide the information to the management team.
正解：C
質問 # 28
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 effectiveness
- C. Safety and effectiveness
- D. Quality and failure risk
正解：C
質問 # 29
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?
- A. Frequent communication
- B. Follow-up meeting after submission
- C. Documented agreement
- D. Early collaboration
正解：A
質問 # 30
Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal available
therapy?
- A. Active-controlled
- B. Placebo-controlled
- C. Cross-over
- D. Dose-ranging
正解：C
質問 # 31
A company is currently marketing an implantable orthopedic medical device. The R&D department is
planning to change the material used for the implant. The R&D department states that the change does
not impact the safety and effectiveness of the product. What action should the regulatory affairs
professional take FIRST?
- A. No action is needed in this situation.
- B. Review the content of change and supporting data for the equivalency with the current material.
- C. Write a memo to file since the change does not impact product safety and effectiveness.
- D. Prepare regulatory submissions that detail the medical device's change in materials.
正解：B
質問 # 32
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. Obtain a copy of the proposed regulation and analyze the impact.
- B. Inform the company's senior management and arrange an emergency meeting
- C. Arrange for additional testing of the product at the testing facility.
- D. Consult with the company's legal department regarding options.
正解：A
質問 # 33
Which of the following is the PRIMARY purpose of an audit report?
- A. To carry out a complete review of product applications
- B. To train sales representatives
- C. To define how to prepare new product submissions
- D. To document compliance history
正解：D
質問 # 34
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. Redesign the device.
- B. Perform another risk-benefit analysis.
- C. Add a warning in the IFU.
- D. Discontinue the project.
正解：A
質問 # 35
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?
- A. Request an inspection from a regulatory authority.
- B. Request documentation from the sub-contractor.
- C. Ask the vendor to take responsibility.
- D. Document and perform audits.
正解：D
質問 # 36
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the
medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Notify the global regulatory authorities.
- B. Withdraw the affected product from the markets.
- C. Assess the potential safety risk.
- D. Send a "Dear Dr." letter to customers.
正解：A
質問 # 37
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この試験は、規制関係者の成長と発展を支援するグローバルな組織であるRegulatory Affairs Professionals Society（RAPS）によって提供されています。RAPS RAC-GSの認定は、雇用主によって広く認められており、規制関係者が規制関連のキャリアを進める上で貴重な資格となっています。
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