[Jan-2022] RAC-US exam torrent RAPS study guide
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NEW QUESTION 42
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 43
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
- B. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- C. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
- D. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
Answer: C
NEW QUESTION 44
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. Plan regulatory approval update meetings with senior management and stakeholders.
- C. Initiate a global submission process after all submission data are finalized.
- D. Utilize the STED template to complete global requirements.
Answer: A
NEW QUESTION 45
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 46
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
- A. Proposed dose and volume of administration
- B. Biological activity with species and/or tissue specificity
- C. Proposed product route and frequency of administration
- D. Immunochemical and functional tests
Answer: B
NEW QUESTION 47
During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?
- A. ISO 14971 risk analysis
- B. Failure mode and effect analysis
- C. Hazard and operability study
- D. Fault tree analysis
Answer: A
NEW QUESTION 48
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. Contact the legal department and ask them how to proceed.
- C. Resubmit the entire package.
- D. Inform upper management immediately.
Answer: A
NEW QUESTION 49
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
- A. "Is the product an established gold standard?"
- B. "Is the product profitable for the manufacturer?"
- C. "Is the product better than currently available alternatives?"
- D. "Has the product been approved for mor&4nan 10 years?"
Answer: C
NEW QUESTION 50
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 51
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
- A. Adverse event caused by patient conditions
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction occurring before the end of service life of the medical device
- D. Malfunction protection operated correctly
Answer: A
NEW QUESTION 52
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?
- A. Prepare the legal team in Country Y for possible litigations.
- B. Initiate a mandatory recall of the product in Country Y.
- C. Review alt distribution records and complaints reported in Country Y.
- D. Draft a formal letter to customers in Country Y about this recall.
Answer: C
NEW QUESTION 53
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Send a "Dear Dr." letter to customers.
- B. Withdraw the affected product from the markets.
- C. Assess the potential safety risk.
- D. Notify the global regulatory authorities.
Answer: D
NEW QUESTION 54
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
- A. Risk analysis
- B. Instructions for use
- C. Product literature
- D. Essential principles
Answer: A
NEW QUESTION 55
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. Inform the local regulatory authority of the letter and discuss how to respond.
- B. Inform the legal department of the letter and discuss how to respond.
- C. Acknowledge receipt of the letter in a written response but do nothing further.
- D. Inform Company X that it has no right to send such a letter and do nothing further.
Answer: B
NEW QUESTION 56
A company is developing a new line of products in an area that is new to the company.
What is the BEST approach?
- A. Summarize regulatory documents and history and provide the information to the management team.
- B. Ask the trade association representative to provide an overview of the new product area to the marketing team.
- C. Obtain competitor research and provide the information to the management team.
- D. Obtain regulatory documents and history and provide the information to R&D.
Answer: A
NEW QUESTION 57
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. Guidance documents for the device
- B. Determination of product design deliverables
- C. Approved indications of the drug
- D. Determination of primary mode of action
Answer: B
NEW QUESTION 58
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