RAC-GS 무료 덤프문제 온라인 액세스

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?

• A.E. Examine decisions made about similar products in Country Y to propose the classification ofthe product.
• B.Apply for review of the additional part of the product as a pharmaceutical product in Country
• C.Submit the product for review as a pharmaceutical product in Country Y.
• D.Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

• A.Subject's hospitalization is prolonged during the clinical trial.
• B.Subject is hospitalized due to complications of the product administration.
• C.Subject is hospitalized for the purpose of product administration.
• D.Subject's hospitalization is due to an unscheduled hip operation.

The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

• A.Production
• B.Quality
• C.Analytical
• D.Regulatory

A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

• A.Negotiate with colleagues and the authority to find a better time.
• B.Arrange for an inspection without all intended personnel.
• C.Inform the authority that the time is not suitable and request a new time
• D.Insist that key personnel be available for the inspection.

The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?

• A.Draft a formal letter to customers in Country Y about this recall.
• B.Initiate a mandatory recall of the product in Country Y.
• C.Prepare the legal team in Country Y for possible litigations.
• D.Review alt distribution records and complaints reported in Country Y.