RAC-GS Online Practice Questions and Answers

The safety database for an anti-hypertensive drug consists of the following: 461 patients exposed for three months 343 patients exposed for six months 112 patients exposed for nine months 74 patients exposed for 12 months Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

A. 100 patients for 12 months

B. 200 patients for nine months

C. 500 patients for three months

D. 3.000 total patient exposures

A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

A. Recommend an immediate product recall.

B. Compare the approved text with the product label

C. Notify the regulatory authority.

D. Inform the production team.

At a recent scientific meeting,Company Y had two booths:

At one booth,Company Y provided brochures on a completed Phase II study.

In an adjacent booth, Company Y's sales professionals were promoting one of Company Y's marketed products.

A regulatory affairs-professional at Company X sends a letter to a counterpart at Company Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?

A. Acknowledge receipt of the letter in a written response but do nothing further.

B. Inform the legal department of the letter and discuss how to respond.

C. Inform Company X that it has no right to send such a letter and do nothing further.

D. Inform the local regulatory authority of the letter and discuss how to respond.

A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

A. The ISO national member body

B. The ISO technical committee in charge of the area

C. The ISO Secretariat

D. The country's regulatory authority

The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon.

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

A. Transfer the notice of the upcoming international monograph change to QA for further processing.

B. Prepare the international monograph change submission first and then prepare the local change when required.

C. Confirm that the international monograph change is not related to local pharmacopeia.

D. Analyze the impact of the international monograph change on the local pharmacopeia.

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. Stop product manufacturing.

B. Establish validation procedures.

C. Assess the impact of the changes.

D. Review the stability data for the changes.

The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to serious injuries to patients. This product also is distributed in Country Y.

What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?

A. Draft a formal letter to customers in Country Y about this recall.

B. Initiate a mandatory recall of the product in Country Y.

C. Review alt distribution records and complaints reported in Country Y.

D. Prepare the legal team in Country Y for possible litigations.

Which of the following is NOT required to be included in a marketing application?

A. Final printed label

B. Quality, safety, and efficacy Information

C. Administrative forms

D. Evidence of fee payment

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

A. Site license

B. Product license

C. Import license

D. Export license

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

A. 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

B. 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

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

D. 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