최신 RAC-GS 무료덤프 - RAPS Regulatory Affairs Certification (RAC) Global Scope
During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate FIRST step for the company to take?
정답: D
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?
정답: A,C
An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?
정답: A,C
According to ICH, how many stability time points are normally required to establish a two-year shelf life for a product?
정답: B
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?
정답: C
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
정답: A,C
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
Which of the following is the most appropriate action to take FIRST?
정답: B
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X.
where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?
where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?
정답: A,D
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
정답: A
Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?
정답: B