合格できるRAPS Regulatory Affairs Certification (RAC) US試験最速合格保証最近更新されたPassTest問題集！ [Q60-Q76]

質問60、 According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

質問61、 According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

質問62、 A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company’s new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

質問63、 A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

質問64、 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?

質問65、 In which section of the ICH Common Technical Document will the overview of clinical data appear?

質問66、 Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

質問67、 Which of the following claims would classify an apple as a drug?

質問68、 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?

質問69、 Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

質問70、 A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

質問71、 SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

質問72、 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?

質問73、 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?

質問74、 Which of the following is NOT required to be included in a marketing application?

質問75、 A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

質問76、 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?