Free Access RAPS.RAC-US.v2022-06-05.q36 Practice Test (Page 8)

Question 31

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.Insist that key personnel be available for the inspection.

C.Arrange for an inspection without all intended personnel.

D.Inform the authority that the time is not suitable and request a new time

Question 32

In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

A.Product stability

B.Product requirements

C.Product formulation

D.Product registration

Question 33

Why is it necessary to run supplemental safety pharmacology studies?

A.To provide adverse reaction reports and the results of the statistical data to the regulatory authority

B.To comply with regulatory authority requirements related to clinical studies

C.To substitute the utilization of GLP

D.To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

Question 34

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A.Results of a three-year, post-market patient survey indicate the product is superior.

B.Government survey data indicate the product is superior.

C.In vitro studies show the product to be superior.

D.Results of adequate, well-controlled comparative clinical trial show the product is superior.

Question 35

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A.Quality and effectiveness

B.Quality and failure risk

C.Safety and effectiveness

D.Safety and failure risk

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