최신 RAC Regulatory Affairs Certification RAC-US 무료샘플문제:
1. A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
A) Insist that key personnel be available for the inspection.
B) Arrange for an inspection without all intended personnel.
C) Inform the authority that the time is not suitable and request a new time
D) Negotiate with colleagues and the authority to find a better time.
2. Which of the following BEST describes the purpose of the ICH?
A) To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
B) To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
C) To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
D) To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
3. 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.
4. Why is it necessary to run supplemental safety pharmacology studies?
A) To comply with regulatory authority requirements related to clinical studies
B) To substitute the utilization of GLP
C) To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
D) To provide adverse reaction reports and the results of the statistical data to the regulatory authority
5. 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) Discontinue the project.
D) Perform another risk-benefit analysis.
질문과 대답:
| 질문 # 1 정답: D | 질문 # 2 정답: D | 질문 # 3 정답: B | 질문 # 4 정답: C | 질문 # 5 정답: B |
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