Q46. In which section of the ICH Common Technical Document will the overview of clinical data appear?

Q47. Company X and Company Y both have products for the treatment of rare genetic diseases.
Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

Q48. 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?

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. Which question is pertinent to demonstrate a new pharmaceutical’s effectiveness during evaluation by a reimbursement agency?

Q51. 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?

Q52. A process is ultimately validated to ensure which of the following?

Q53. Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

Q54. Which of the following statements regarding export regulations for an approved product is CORRECT?

Q55. Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

Q56. 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?

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. 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?

Q59. 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?

Q60. When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

Q61. Which term does NOT describe the same concept as the others?

Q62. During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?