최신 RAC-GS 무료덤프 - RAPS Regulatory Affairs Certification (RAC) Global Scope
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
정답: B
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?
정답: C
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?
정답: C
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?
정답: B
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
정답: A
A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?
정답: C
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
정답: C
At a recent scientific meeting,Company Y had two booths:
At one booth,Company Y provided brochures on a completed Phase II study.
In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
At one booth,Company Y provided brochures on a completed Phase II study.
In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
정답: C,D
Which of the following is the PRIMARY purpose of an audit report?
정답: A
A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
정답: B