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A quick overview of the RAPS RAC-US Certification Exam:
Regulatory Affairs Certification US is simply called RAC-US Certification Exam. It is a rigorous, technical exam consisting of questions across two disciplines - Pharmaceutical and Medical Devices. The exam is administered through the RAPS website which also serves as a platform for the RAC certification program. Candidates need to pass both the RAC-Drugs exam and RAC-Devices exam in order to achieve RAC-US Certification. Clinical qualification is not required for this exam. RAC-US exam dumps will help you to get prepared for the exam, with ease.
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Our RAC-US study materials combine the key information about the test in the past years’ test papers and the latest emerging knowledge points among the industry to help the clients both solidify the foundation and advance with the times. We give priority to the user experiences and the clients’ feedback, RAC-US Study Materials will constantly improve our service and update the version to bring more conveniences to the clients and make them be satisfied.
RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q17-Q22):
NEW QUESTION # 17
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. Arrange for additional testing of the product at the testing facility.
- B. Obtain a copy of the proposed regulation and analyze the impact.
- C. Consult with the company's legal department regarding options.
- D. Inform the company's senior management and arrange an emergency meeting
Answer: B
NEW QUESTION # 18
The requirements for document control are located in which of the following documents?
- A. WHO guidelines
- B. ISO 13485
- C. IEC 60601
- D. ICH guidelines
Answer: B
NEW QUESTION # 19
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?
- A. Three years after the last clinical study site was supplied with investigational drugs
- B. For at least two years after the last approval of an application in an ICH region
- C. For a minimum of 10 years after completion of the clinical study
- D. Until the product has been discontinued from marketing in all ICH regions
Answer: B
NEW QUESTION # 20
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
- A. Increase the frequency of monitoring visits.
- B. Inform the institution that granted a medical license to the Pi.
- C. Terminate the PI and inform the regulatory authorities.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: C
NEW QUESTION # 21
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
Answer: D
NEW QUESTION # 22
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