Regulatory Affairs Certification (RAC) Global Scope (RAC-GS) Free Practice Test

Question 1

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. In vitro studies show the product to be superior.

C. Government survey data indicate the product is superior.

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

Correct Answer: D

Question 2

When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

A. Phase I and II clinical trials

B. Pre-clinical studies

C. Phase III clinical trials

D. Phase I clinical trials

Correct Answer: C

Question 3

In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?

A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.

B. Inform the internal departments to redesign the product to comply with this requirement.

C. Notify senior management that the product cannot be registered.

D. Inform the regulatory authority that such a requirement is not applicable to the product.

Correct Answer: A

Question 4

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?

A. Assess the impact of the changes.

B. Establish validation procedures.

C. Review the stability data for the changes.

D. Stop product manufacturing.

Correct Answer: A,D

Question 5

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

A. Compatibility and safety

B. Volume and material

C. Efficacy and material

D. Safety and efficacy

Correct Answer: A

Question 6

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. Product release and validation

B. Concept development and validation

C. Concept development and early technical design

D. Early technical design and product release

Correct Answer: C

Question 7

Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

A. Develop documented procedures for regulatory compliance processes and train personnel.

B. Document any failure to follow regulatory compliance processes in employee performancereviews.

C. Train employees on all regulatory compliance processes using state-of-the-art systems.

D. Train all new employees on regulatory compliance processes and assign a mentor to them.

Correct Answer: A

Question 8

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. Safety and failure risk

C. Quality and failure risk

D. Safety and effectiveness

Correct Answer: D

Question 9

According to ISO 14971,what is the FIRST step when developing a risk management plan for a medical device?

A. Risk management

B. Risk control

C. Risk estimation

D. Risk analysis

Correct Answer: D

Question 10

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 requirements

B. Product formulation

C. Product stability

D. Product registration

Correct Answer: C

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RAPS Regulatory Affairs Certification (RAC) Global Scope (RAC-GS) Free Practice Test