최신 RAC-GS 무료덤프 - RAPS Regulatory Affairs Certification (RAC) Global Scope
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
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
정답: B
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
정답: D
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?
정답: B
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
정답: A,C
Who has the PRIMARY responsibility for recall of products with quality defects?
정답: B
Which of the following BEST describes the purpose of the ICH?
정답: C
A manufacturer is involved in a recall event process for a plasma-derived product. From
which stage should the manufacturer be able to trace back the product?
which stage should the manufacturer be able to trace back the product?
정답: A
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
정답: A
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?
What should be done in response to identifying the impurity?
정답: C