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下載Regulatory Affairs Certification (RAC) US考試題庫
NEW QUESTION 48
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
- A. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation - B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
- C. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
- D. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
Answer: A
NEW QUESTION 49
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?
- A. Identify countries where special requirements exist during the product development phase.
- B. Utilize the STED template to complete global requirements.
- C. Initiate a global submission process after all submission data are finalized.
- D. Plan regulatory approval update meetings with senior management and stakeholders.
Answer: A
NEW QUESTION 50
After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?
- A. Verify the procedure in the regulation for the corrections.
- B. Resubmit the entire package.
- C. Inform upper management immediately.
- D. Contact the legal department and ask them how to proceed.
Answer: A
NEW QUESTION 51
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. Inform the institution that granted a medical license to the Pi.
- B. Terminate the PI and inform the regulatory authorities.
- C. Increase the frequency of monitoring visits.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 52
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