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試験番号：RAC-GS 日本語版
試験科目：「Regulatory Affairs Certification (RAC) Global Scope」
最近更新時間：2017-03-09
問題と解答：100
NO.1 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. Inform the internal departments to redesign the product to comply with this requirement.
B. Inform the regulatory authority that such a requirement is not applicable to the product.
C. Notify senior management that the product cannot be registered.
D. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
Answer: D
RAC-GS 本番 RAC-GS 的中率
NO.2 A company is developing a new line of products in an area that is new to the company. What is
the BEST
approach?
A. Obtain regulatory documents and history and provide the information to R&D.
B. Summarize regulatory documents and history and provide the information to the management
team.
C. Obtain competitor research and provide the information to the management team.
D. Ask the trade association representative to provide an overview of the new product area to the
marketing team.
Answer: B
RAC-GS 資料
NO.3 Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of
risk control
activities for a medical device?
A. Failure modes, effects, and criticality analysis
B. Fishbone analysis
C. Fault tree analysis
D. Quality by design analysis
Answer: A
RAC-GS 出題 RAC-GS 返済
NO.4 During a routine review of promotional materials for a product, a regulatory affairs professional
discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
A. Request that doctors stop using the product for the off-label indication.
B. Communicate with the sales department to stop using the promotional materials.
C. Contact the marketing department to recall the product.
D. Allow doctors to use the product for the off-label indication.
Answer: B
RAC-GS 回答 RAC-GS 学習
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