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Good News !!! RAC-GS Regulatory Affairs Certification (RAC) Global Scope is now Stable and With Pass Result

RAC-GS Practice Exam Questions and Answers

Regulatory Affairs Certification (RAC) Global Scope

Last Update 2 days ago
Total Questions : 100

Regulatory Affairs Certification (RAC) Global Scope is stable now with all latest exam questions are added 2 days ago. Incorporating RAC-GS practice exam questions into your study plan is more than just a preparation strategy.

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Question # 1

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

Options:

A.  

Pre-clinical studies

B.  

Phase I clinical trials

C.  

Phase I and II clinical trials

D.  

Phase III clinical trials

Discussion 0
Question # 2

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

Options:

A.  

Product stability

B.  

Product registration

C.  

Product formulation

D.  

Product requirements

Discussion 0
Question # 3

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

Options:

A.  

Quality improvement

B.  

Quality assurance

C.  

Clinical affairs

D.  

Regulatory agency

Discussion 0
Question # 4

A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?

Options:

A.  

Certificate of GMP

B.  

Certificate of Free Sale

C.  

Certificate of Pharmaceutical Product

D.  

Certificate of Analysis for the finished product

Discussion 0
Question # 5

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

Options:

A.  

Volume and material

B.  

Compatibility and safety

C.  

Safety and efficacy

D.  

Efficacy and material

Discussion 0
Question # 6

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

Options:

A.  

"It will make you look younger."

B.  

"It will satisfy hunger."

C.  

"It will whiten teeth."

D.  

"It will prevent colds."

Discussion 0
Question # 7

In which section of the ICH Common Technical Document will the overview of clinical data appear?

Options:

A.  

Module 1

B.  

Module 2

C.  

Module 3

D.  

Module 4

Discussion 0
Question # 8

Which of the following statements regarding export regulations for an approved product is CORRECT?

Options:

A.  

The product must not be in accord with the specifications of the foreign purchaser.

B.  

The product must not be in conflict with the laws of the country to which it is intended for export.

C.  

The product must not be labeled on the outside of the shipping package that it is intended for export.

D.  

The product must not be sold or offered for sale in domestic commerce.

Discussion 0
Question # 9

A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?

Options:

A.  

Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

B.  

Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

C.  

Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

D.  

Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

Discussion 0
Question # 10

According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

Options:

A.  

3

B.  

5

C.  

10

D.  

15

Discussion 0
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