Latest [Jul 20, 2023] RAPS RAC-US Exam Practice Test To Gain Brilliante Result [Q46-Q62]

Q46. Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

Q47. 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?

Q48. 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?

Q49. 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?

Q50. A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

Q51. Which of the following is NOT required to be included in a marketing application?

Q52. As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

Q53. According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

Q54. At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

Q55. A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

Q56. 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?

Q57. Following the introduction of a new regulation, an evaluation of the company’s products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

Q58. A process is ultimately validated to ensure which of the following?

Q59. 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?

Q60. 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 the antibiotics 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?

Q61. The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

Q62. A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?