Ultimate Guide to Prepare Free RAPS RAC-US Exam Questions & Answer [Q25-Q42]

Q25. According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

Q26. Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

Q27. 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?

Q28. According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

Q29. A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?

Q30. As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

Q31. 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?

Q32. Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

Q33. The requirements for document control are located in which of the following documents?

Q34. 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?

Q35. Which of the following statements regarding export regulations for an approved product is CORRECT?

Q36. Which of the following is MOST appropriate for the purpose of lot release of biologics?

Q37. 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?

Q38. Which of the following BEST describes the purpose of the ICH?

Q39. 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?

Q40. A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

Q41. An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?

Q42. During routine surveillance, a regulatory authority sent a company the following communication: “Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company’s product. The regulatory authority is evaluating these issues to determine the need for any regulatory action.” Which action would be the most appropriate
FIRST step for the company to take?