最新的RAC Regulatory Affairs Certification認證 RAC-GS考試題庫

問題1

According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

A. Production of Intermediate(s)

B. Introduction of the API starting material

C. Physical processing and packaging

D. Isolation and purification

正確答案: C

問題2

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A. Request that doctors stop using the product for the off-label indication.

B. Communicate with the sales department to stop using the promotional materials.

C. Contact the marketing department to recall the product.

D. Allow doctors to use the product for the off-label indication.

正確答案: B

問題3

A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

A. Clinical experience

B. Adverse event reports

C. Clinical investigations

D. Literature search

正確答案: C

問題4

A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A. Concept development and validation

B. Early technical design and product release

C. Concept development and early technical design

D. Product release and validation

正確答案: C

問題5

In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

A. Safety and efficacy

B. Efficacy and material

C. Volume and material

D. Compatibility and safety

正確答案: D

問題6

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

B. Insist that key personnel be available for the inspection.

C. Arrange for an inspection without all intended personnel.

D. Negotiate with colleagues and the authority to find a better time.

正確答案: D

問題7

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

A. Biological activity with species and/or tissue specificity

B. Proposed dose and volume of administration

C. Immunochemical and functional tests

D. Proposed product route and frequency of administration

正確答案: A

問題8

What is the LAST stage in the development of a quality risk management process for a medical device?

A. Risk analysis

B. Risk reduction

C. Risk acceptance

D. Risk evaluation

正確答案: C

問題9

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

A. Early collaboration

B. Follow-up meeting after submission

C. Frequent communication

D. Documented agreement

正確答案: C

問題10

Which of the following BEST describes the purpose of the ICH?

A. To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions

B. To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions

C. To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions

D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

正確答案: D

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