[Dec 12, 2021] Fully Updated RAC Regulatory Affairs Certification (RAC-US) Certification Sample Questions
Latest RAPS RAC-US Real Exam Dumps PDF
NEW QUESTION 23
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
- A. Quality and effectiveness
- B. Safety and effectiveness
- C. Safety and failure risk
- D. Quality and failure risk
Answer: B
NEW QUESTION 24
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
- A. Acknowledge receipt of the letter in a written response but do nothing further.
- B. Inform the local regulatory authority of the letter and discuss how to respond.
- C. Inform Company X that it has no right to send such a letter and do nothing further.
- D. Inform the legal department of the letter and discuss how to respond.
Answer: D
NEW QUESTION 25
Which of the following is the PRIMARY purpose of an audit report?
- A. To train sales representatives
- B. To define how to prepare new product submissions
- C. To carry out a complete review of product applications
- D. To document compliance history
Answer: D
NEW QUESTION 26
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?
- A. International import and export regulations
- B. The time frame in which the patent will expire
- C. Doha Declaration in the TRIPS Agreement
- D. The stability of the drug in all zone conditions
Answer: D
NEW QUESTION 27
Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?
- A. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
- B. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
- C. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
- D. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
Answer: C
NEW QUESTION 28
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
- A. Class A
- B. Class C
- C. Class D
- D. Class B
Answer: B
NEW QUESTION 29
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?
- A. Explore litigation strategy for patent infringements on the drug.
- B. Conduct a Phase III study for a new unrelated indication of the drug.
- C. Develop a generic version of the drug.
- D. Develop a better brand-name drug in the same class.
Answer: C
NEW QUESTION 30
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized due to complications of the product administration.
- B. Subject is hospitalized for the purpose of product administration.
- C. Subject's hospitalization is due to an unscheduled hip operation.
- D. Subject's hospitalization is prolonged during the clinical trial.
Answer: B
NEW QUESTION 31
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Allow the auditor accompanied access to the room to retrieve the records.
- B. Deny the auditor access to the room and retrieve only the requested records.
- C. Deny the auditor access to the room and records due to confidentiality concerns.
- D. Allow the auditor access to the room and records due to the current audit.
Answer: A
NEW QUESTION 32
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?
- A. Add a warning in the IFU.
- B. Perform another risk-benefit analysis.
- C. Discontinue the project.
- D. Redesign the device.
Answer: D
NEW QUESTION 33
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
- A. Marketing materials
- B. Clinical trial data
- C. Safety issues
- D. Intellectual properly
Answer: C
NEW QUESTION 34
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
- A. Early technical design and product release
- B. Concept development and early technical design
- C. Concept development and validation
- D. Product release and validation
Answer: B
NEW QUESTION 35
The requirements for document control are located in which of the following documents?
- A. ISO 13485
- B. WHO guidelines
- C. ICH guidelines
- D. IEC 60601
Answer: A
NEW QUESTION 36
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 description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
- C. 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
- D. 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
Answer: A
NEW QUESTION 37
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. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."
- 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, but we can perform an additional analysis for a specific safety concern, if necessary."
- D. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."
Answer: C
NEW QUESTION 38
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. Review the company's existing Quality Management System
- B. Complete a gap analysis to identify options.
- C. Reformulate the products with a replacement material.
- D. Qualify another supplier and execute a supplier agreement.
Answer: D
NEW QUESTION 39
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
- A. Product literature
- B. Essential principles
- C. Instructions for use
- D. Risk analysis
Answer: D
NEW QUESTION 40
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
- A. Quality by design analysis
- B. Failure modes, effects, and criticality analysis
- C. Fishbone analysis
- D. Fault tree analysis
Answer: B
NEW QUESTION 41
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