Weekend Special Limited Time 70% Discount Offer - Ends in 0d 00h 00m 00s - Coupon code = simple70

Home
RAPS
RAC Regulatory Affairs Certification
RAC-GS
Regulatory Affairs Certification (RAC) Global Scope Questions and Answers

Pass the RAPS RAC Regulatory Affairs Certification RAC-GS Questions and answers with ExamsMirror

Practice at least 50% of the questions to maximize your chances of passing.

Exam RAC-GS Premium Access

View all detail and faqs for the RAC-GS exam

Go to Exam

485 Students Passed

87% Average Score

98% Same Questions

Viewing page 1 out of 3 pages

Viewing questions 1-10 out of questions

Questions # 1:

As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

Options:

Inform the regulatory authorities.

Delay the start of product production.

Correct the label text.

Abort the product launch.

Answer

Questions # 2:

During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.

Which action is MOST appropriate for the regulatory affairs professional to take?

Options:

Allow the auditor access to the room and records due to the current audit.

Allow the auditor accompanied access to the room to retrieve the records.

Deny the auditor access to the room and retrieve only the requested records.

Deny the auditor access to the room and records due to confidentiality concerns.

Answer

Questions # 3:

One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

Options:

"Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."

"We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."

"We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."

"We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."

Answer

Questions # 4:

You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

Options:

Discuss with regulatory authorities to investigate how to have the off-label indication approved.

No action is required since it is an off-label use.

Advise the senior management to send a "Dear Dr." letter.

File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

Answer

Questions # 5:

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

Options:

Inadequate training

Late and/or incorrect deliverables

Causes of non-conformities

Adverse environmental impacts

Answer

Questions # 6:

A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.

What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

Options:

The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.

The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.

The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.

The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

Answer

Questions # 7:

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

Options:

"It will make you look younger."

"It will satisfy hunger."

"It will whiten teeth."

"It will prevent colds."

Answer

Questions # 8:

Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB?

Options:

A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation

A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use

A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation

Answer

Questions # 9:

Who has the PRIMARY responsibility for recall of products with quality defects?