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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q39-Q44):

NEW QUESTION # 39
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. For a minimum of 10 years after completion of the clinical study
• B. Three years after the last clinical study site was supplied with investigational drugs
• C. Until the product has been discontinued from marketing in all ICH regions
• D. For at least two years after the last approval of an application in an ICH region

Answer: D
NEW QUESTION # 40
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. Randomization scheme and codes
• C. List of lECs or lRBs
• D. Protocol and protocol amendments

Answer: A
NEW QUESTION # 41
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

• A. "Is the product an established gold standard?"
• B. "Has the product been approved for mor&4nan 10 years?"
• C. "Is the product profitable for the manufacturer?"
• D. "Is the product better than currently available alternatives?"

Answer: D
NEW QUESTION # 42
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

• A. "Product X is effective in all patients with arthritis."
• B. "Product X is effective for the treatment of arthritis."
• C. "Product X is safe for arthritis and without side effects."
• D. "Product X is a guaranteed cure for arthritis."

Answer: B
NEW QUESTION # 43
One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

• A. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
• B. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."
• C. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
• D. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."

Answer: D
NEW QUESTION # 44
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