2021年最新のRAC-GS試験解答最新版Fast2test RAC-GSのPDF問題集をダウンロードせよ（100問題と解答)
無料2021年最新のRAC Regulatory Affairs Certification RAC-GS問題集を提供しております！Fast2test
質問 43
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. Review the content of change and supporting data for the equivalency with the current material.
- B. Prepare regulatory submissions that detail the medical device's change in materials.
- C. Write a memo to file since the change does not impact product safety and effectiveness.
- D. No action is needed in this situation.
正解: A
質問 44
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 design patents in target countries.
- B. Use the community patent system.
- C. Use the Madrid system.
- D. File patents of interest in target countries.
正解: D
質問 45
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 regulatory authority, ask for clarification about the delay, and demand a decision be made
regarding the submission. - B. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any
outstanding questions. - C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory
authority's response time. - D. Contact the local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission.
正解: B
質問 46
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. Regulatory application summary
- C. Safety-related reporting
- D. Risk management process
正解: A
質問 47
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. Previous actions taken by regulatory authorities on similar products
- B. Regulatory requirements for labeling and packaging
- C. Potential clinical sites for the Phase III clinical trial
- D. Capacity of the manufacturing facilities to fully produce the new product
正解: A
質問 48
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. Initiate a global submission process after all submission data are finalized.
- D. Plan regulatory approval update meetings with senior management and stakeholders.
正解: A
質問 49
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. Add a warning in the IFU.
- B. Redesign the device.
- C. Perform another risk-benefit analysis.
- D. Discontinue the project.
正解: B
質問 50
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control
activities for a medical device?
- A. Quality by design analysis
- B. Fault tree analysis
- C. Fishbone analysis
- D. Failure modes, effects, and criticality analysis
正解: D
質問 51
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. Export license
- D. Import license
正解: B
質問 52
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the
effect of the patent expiration, which is the BEST action for the company to take?
- A. Develop a better brand-name drug in the same class.
- B. Conduct a Phase III study for a new unrelated indication of the drug.
- C. Explore litigation strategy for patent infringements on the drug.
- D. Develop a generic version of the drug.
正解: D
質問 53
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation
based on which of the following?
- A. Essential principles
- B. Risk analysis
- C. Product literature
- D. Instructions for use
正解: B
質問 54
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: D
質問 55
Which of the following is NOT required to be included in a marketing application?
- A. Quality, safety, and efficacy Information
- B. Administrative forms
- C. Final printed label
- D. Evidence of fee payment
正解: D
質問 56
Which of the following criteria is MOST appropriate to define the animal species needed for the
pre-clinical toxicity testing of a biotechnology product?
- A. Proposed dose and volume of administration
- B. Proposed product route and frequency of administration
- C. Biological activity with species and/or tissue specificity
- D. Immunochemical and functional tests
正解: C
質問 57
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Efficacy confirmation
- B. Quality verification
- C. Inventory control
- D. Safety assurance
正解: B
質問 58
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product
does not meet one of the specific technical requirements of the regulation. However, competitors with
substantially similar products have claimed compliance with the requirement and received approval.
Which action should the regulatory affairs professional take FIRST?
- A. Notify senior management that the product cannot be registered.
- B. Inform the internal departments to redesign the product to comply with this requirement.
- C. Inform the regulatory authority that such a requirement is not applicable to the product.
- D. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
正解: D
質問 59
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A statistically significant increase in the number of deaths in an animal dose finding study
- B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
- C. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
- D. A major safety finding from a newly completed animal carcinogenicity study
正解: C
質問 60
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RAC-GS試験解答問題集：https://jp.fast2test.com/RAC-GS-premium-file.html（100問題と解答)