RAC-GS 日本語資格取得 & RAC-GS 問題と解答
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試験番号：RAC-GS テキスト試験科目：「Regulatory Affairs Certification (RAC) Global Scope」
最近更新時間：2017-06-28
問題と解答：100
NO.1 Who has the PRIMARY responsibility for recall of products with quality defects?
A. Distributor
B. Regulatory authority
C. Consumer
D. Manufacturer
Answer: D
NO.2 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. Contact the marketing department to recall the product.
B. Communicate with the sales department to stop using the promotional materials.
C. Allow doctors to use the product for the off-label indication.
D. Request that doctors stop using the product for the off-label indication.
Answer: B
RAC-GS クラムメディア
NO.3 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. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
D. Notify senior management that the product cannot be registered.
Answer: C
RAC-GS スキル
NO.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. Obtain a copy of the proposed regulation and analyze the impact.
B. Arrange for additional testing of the product at the testing facility.
C. Inform the company's senior management and arrange an emergency meeting
D. Consult with the company's legal department regarding options.
Answer: A
RAC-GS 前提 RAC-GS ファンデーション
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