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Reliable RAC-US Test Price | Vce RAC-US File & RAC-US Real Question
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NEW QUESTION 41
According to ICH, which of the following components of study information is NOT required in a clinical study report?

  • A. Detailed CV of all investigators
  • B. Protocol and protocol amendments
  • C. List of lECs or lRBs
  • D. Randomization scheme and codes

Answer: A

 

NEW QUESTION 42
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

  • A. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
  • B. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
  • C. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
  • D. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

Answer: D

 

NEW QUESTION 43
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?

  • A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
  • B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
  • C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
  • D. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

Answer: A

 

NEW QUESTION 44
What is the LAST stage in the development of a quality risk management process for a medical device?

  • A. Risk reduction
  • B. Risk evaluation
  • C. Risk analysis
  • D. Risk acceptance

Answer: D

 

NEW QUESTION 45
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