RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 71:

  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 is an updated version of a compliant device from the same manufacturer and contains no substantive change.
  B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
  C. The manufacturer's experience level with the type of IVD medical device is limited.
  D. The device incorporates well-established technology that is already present in the market.
  C. The manufacturer's experience level with the type of IVD medical device is limited.

• Question 72:

  SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

  A. Inadequate training
  B. Late and/or incorrect deliverables
  C. Causes of non-conformities
  D. Adverse environmental impacts
  C. Causes of non-conformities

• Question 73:

  A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

  A. Recommend an immediate product recall.
  B. Compare the approved text with the product label
  C. Notify the regulatory authority.
  D. Inform the production team.
  B. Compare the approved text with the product label

• Question 74:

  What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

  A. Safety and failure risk
  B. Safety and effectiveness
  C. Quality and failure risk
  D. Quality and effectiveness
  B. Safety and effectiveness

• Question 75:

  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. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
  B. No action is required since it is an off-label use.
  C. Advise the senior management to send a "Dear Dr." letter.
  D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
  A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

• Question 76:

  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. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
  B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
  C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.
  D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
  A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

• Question 77:

  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 ManagementSystem
  B. Reformulate the products with a replacement material.
  C. Qualify another supplier and execute a supplier agreement.
  D. Complete a gap analysis to identify options.
  C. Qualify another supplier and execute a supplier agreement.
  D. Complete a gap analysis to identify options.

• Question 78:

  A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y. The company is proposing to start marketing the coated device in Country Y. Which regulatory approach should the company propose?

  A. Submit the product for review as a pharmaceutical product in Country Y.
  B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
  C. Apply for review of the additional part of the product as a pharmaceutical product in Country
  D. Examine decisions made about similar products in Country Y to propose the classification ofthe product.
  C. Apply for review of the additional part of the product as a pharmaceutical product in Country
  D. Examine decisions made about similar products in Country Y to propose the classification ofthe product.

• Question 79:

  In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

  A. Volume and material
  B. Compatibility and safety
  C. Safety and efficacy
  D. Efficacy and material
  B. Compatibility and safety

• Question 80:

  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. Inform the institution that granted a medical license to the Pi.
  C. Send a letter of complaint to the Ethics Committee that approved the site.
  D. Terminate the PI and inform the regulatory authorities.
  D. Terminate the PI and inform the regulatory authorities.