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Download Regulatory Affairs Certification (RAC) US Exam Dumps
NEW QUESTION 36
In which section of the ICH Common Technical Document will the overview of clinical data appear?
Answer: A
NEW QUESTION 37
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?
Answer: A
NEW QUESTION 38
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
Answer: A
NEW QUESTION 39
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?
Answer: D
NEW QUESTION 40
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
Answer: A
NEW QUESTION 41
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