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質問 32
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?
- A. Quality
- B. Production
- C. Analytical
- D. Regulatory
正解: A
質問 33
A process is ultimately validated to ensure which of the following?
- A. The process meets the quality system requirements.
- B. The process meets the regulatory requirements.
- C. The process consistently produces the desired results.
- D. The process consistently meets the desired Quantity standards
正解: C
質問 34
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
- A. Write a memo to file since the change does not impact product safety and effectiveness.
- B. No action is needed in this situation.
- C. Prepare regulatory submissions that detail the medical device's change in materials.
- D. Review the content of change and supporting data for the equivalency with the current material.
正解: D
質問 35
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. Advise the senior management to send a "Dear Dr." letter.
- B. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
- C. No action is required since it is an off-label use.
- D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
正解: D
質問 36
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 acceptance
- D. Risk analysis
正解: C
質問 37
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
- A. Insist that key personnel be available for the inspection.
- B. Arrange for an inspection without all intended personnel.
- C. Negotiate with colleagues and the authority to find a better time.
- D. Inform the authority that the time is not suitable and request a new time
正解: C
質問 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?
- A. 0
- B. 1
- C. 2
- D. 3
正解: D
質問 39
During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate
FIRST step for the company to take?
- A. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
- B. Contact the regulatory authority to argue that its conclusions are wrong.
- C. Wait for the regulatory authority's final publication on its findings.
- D. Contact the regulatory authority to discuss its findings.
正解: D
質問 40
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?
- A. Confirm that the international monograph change is not related to local pharmacopeia.
- B. Analyze the impact of the international monograph change on the local pharmacopeia.
- C. Transfer the notice of the upcoming international monograph change to QA for further processing.
- D. Prepare the international monograph change submission first and then prepare the local change when required.
正解: C
質問 41
According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?
- A. 30c C and 65% RH
- B. 30: C and 75% RH
- C. 30 C and 35% RH
- D. 25: C and 60% RH
正解: B
質問 42
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Compatibility and safety
- B. Volume and material
- C. Efficacy and material
- D. Safety and efficacy
正解: A
質問 43
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
- A. Determination of product design deliverables
- B. Approved indications of the drug
- C. Determination of primary mode of action
- D. Guidance documents for the device
正解: A
質問 44
Which of the following double-blind clinical trial designs would be MOST appropriate for a
Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?
- A. Placebo-controlled
- B. Dose-ranging
- C. Active-controlled
- D. Cross-over
正解: D
質問 45
A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?
- A. Use the Madrid system.
- B. File patents of interest in target countries.
- C. Use the community patent system.
- D. File design patents in target countries.
正解: B
質問 46
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?
- A. Complete a gap analysis to identify options.
- B. Qualify another supplier and execute a supplier agreement.
- C. Reformulate the products with a replacement material.
- D. Review the company's existing Quality Management System
正解: B
質問 47
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. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
正解: B
質問 48
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
- A. Clinical experience
- B. Clinical investigations
- C. Adverse event reports
- D. Literature search
正解: B
質問 49
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