최신 RAC Regulatory Affairs Certification RAC-GS 무료샘플문제:
1. A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
A) Formulation
B) Property
C) Specification
D) Justification
2. Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
A) The device incorporates well-established technology that is already present in the market.
B) The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
C) Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
D) The manufacturer's experience level with the type of IVD medical device is limited.
3. Which of the following BEST describes the purpose of the ICH?
A) To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions
B) To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
C) To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions
D) To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions
4. 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) Local reimbursement requirements
C) Service operation procedures
D) Written procedure for product traceability
5. As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
A) Site license
B) Export license
C) Product license
D) Import license
질문과 대답:
| 질문 # 1 정답: D | 질문 # 2 정답: D | 질문 # 3 정답: B | 질문 # 4 정답: A | 질문 # 5 정답: A |
985 개 고객 리뷰
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