RAPS RAC-US Exam Questions (Updated 2021) 100% Real Question Answers
Pass RAPS RAC-US Exam Quickly With Exam4Free
NEW QUESTION 17
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. No action is required since it is an off-label use.
- B. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
- C. Advise the senior management to send a "Dear Dr." letter.
- D. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
Answer: D
NEW QUESTION 18
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject's hospitalization is due to an unscheduled hip operation.
- B. Subject's hospitalization is prolonged during the clinical trial.
- C. Subject is hospitalized due to complications of the product administration.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION 19
Which of the following BEST describes the purpose of the ICH?
- A. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
- B. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
- C. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
- D. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
Answer: A
NEW QUESTION 20
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. As many as required by international standards
- B. All senior management from the main office
- C. As many as government attendees
- D. The minimum number of attendees necessary to address the issues
Answer: D
NEW QUESTION 21
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
- A. Inform the internal departments to redesign the product to comply with this requirement.
- B. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
- C. Notify senior management that the product cannot be registered.
- D. Inform the regulatory authority that such a requirement is not applicable to the product.
Answer: B
NEW QUESTION 22
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Quality verification
- B. Inventory control
- C. Efficacy confirmation
- D. Safety assurance
Answer: A
NEW QUESTION 23
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
- A. Causes of non-conformities
- B. Inadequate training
- C. Adverse environmental impacts
- D. Late and/or incorrect deliverables
Answer: A
NEW QUESTION 24
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be sold or offered for sale in domestic commerce.
- B. The product must not be in conflict with the laws of the country to which it is intended for export.
- C. The product must not be labeled on the outside of the shipping package that it is intended for export.
- D. The product must not be in accord with the specifications of the foreign purchaser.
Answer: B
NEW QUESTION 25
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Plasma fractionation
- C. Individual plasma donation
- D. Product distribution
Answer: D
NEW QUESTION 26
A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
- A. Label the product for use in appropriate populations.
- B. Promote off-label use to a carefully selected patient population.
- C. Delay product launch until required studies are completed.
- D. Educate patients and healthcare providers on how to use the product
Answer: B
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. Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.
- B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
- C. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
- D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
Answer: C
NEW QUESTION 28
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Obtain a copy of the proposed regulation and analyze the impact.
- B. Consult with the company's legal department regarding options.
- C. Inform the company's senior management and arrange an emergency meeting
- D. Arrange for additional testing of the product at the testing facility.
Answer: A
NEW QUESTION 29
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. Production
- B. Quality
- C. Analytical
- D. Regulatory
Answer: B
NEW QUESTION 30
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.
- B. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release. - C. Ask that the regulatory authority provide the actual product subject to the complaint.
- D. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
Answer: D
NEW QUESTION 31
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. Concept development and early technical design
- B. Early technical design and product release
- C. Product release and validation
- D. Concept development and validation
Answer: A
NEW QUESTION 32
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
- A. The device incorporates well-established technology that is already present in the market.
- B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
- C. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
- D. The manufacturer's experience level with the type of IVD medical device is limited.
Answer: D
NEW QUESTION 33
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk acceptance
- B. Risk reduction
- C. Risk evaluation
- D. Risk analysis
Answer: A
NEW QUESTION 34
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 at least two years after the last approval of an application in an ICH region
- 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 a minimum of 10 years after completion of the clinical study
Answer: A
NEW QUESTION 35
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Request documentation from the sub-contractor.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 36
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?
- A. The ISO national member body
- B. The ISO technical committee in charge of the area
- C. The ISO Secretariat
- D. The country's regulatory authority
Answer: A
NEW QUESTION 37
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Request a meeting with the regulatory authority to discuss the application.
- B. Consult with the legal department to discuss the best course of action.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- D. Review the regulatory guidelines to determine how to proceed.
Answer: A
NEW QUESTION 38
......
Real RAPS RAC-US Exam Questions [Updated 2021]: https://www.exam4free.com/RAC-US-valid-dumps.html
Prepare RAC-US Question Answers - RAC-US Exam Dumps: https://drive.google.com/open?id=1vp7NTh0c7ymtazUSNYDBy_8QUGlYXJA3
