최신 RAC-GS 무료덤프 - RAPS Regulatory Affairs Certification (RAC) Global Scope
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?
정답: B
A regulation change is imminent and may require further non-clinical testing on a product
currently in Phase III clinical trials. What is the most appropriate action to take FIRST?
currently in Phase III clinical trials. What is the most appropriate action to take FIRST?
정답: D
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?
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?
정답: C,D
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
During the final week of the review of the marketing application, which has fully met all pre-specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
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
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?
정답: D
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?
정답: B
Which of the following situations does NOT require rapid communication to regulatory authorities?
정답: B,C
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?
정답: A,D
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