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QUESTION NO: 1
In which section of the ICH Common Technical Document will the overview of clinical data appear?
A. Module 1
B. Module 2
C. Module 3
D. Module 4
Answer: B
QUESTION NO: 2
You discover that your company's top selling product in the last two years has been used off- label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?
A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
B. No action is required since it is an off-label use.
C. Advise the senior management to send a "Dear Dr." letter.
D. File a report to regulatory authorities and advise the marketing department to prevent future off- label use.
Answer: A
QUESTION NO: 3
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?
A. The minimum number of attendees necessary to address the issues
B. All senior management from the main office
C. As many as government attendees
D. As many as required by international standards
Answer: A
QUESTION NO: 4
Who has the PRIMARY responsibility for recall of products with quality defects?
A. Consumer
B. Distributor
C. Manufacturer
D. Regulatory authority
Answer: C
QUESTION NO: 5
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
A. Safety and failure risk
B. Safety and effectiveness
C. Quality and failure risk
D. Quality and effectiveness
Answer: B
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Updated: May 28, 2022