QUESTION: 9

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

Local reimbursement requirements
Service operation procedures
Training program for sales people
Written procedure for product traceability

Answer(s): C

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QUESTION: 10

According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?

Answer(s): C

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QUESTION: 11

Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

Proposed dose and volume of administration
Biological activity with species and/or tissue specificity
Immunochemical and functional tests
Proposed product route and frequency of administration

Answer(s): B

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QUESTION: 12

Which of the following claims would classify an apple as a drug?

"It will make you look younger."
"It will satisfy hunger."
"It will whiten teeth."
"It will prevent colds."

Answer(s): D

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QUESTION: 9

QUESTION: 10

QUESTION: 11

QUESTION: 12