RAC-GS Online Practice Questions and Answers

Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.

Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.

D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

Which term does NOT describe the same concept as the others?

A. Biosimilars

B. Follow-on protein products

C. Monoclonal antibody

D. Subsequent entry biologics

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

A. Deficiency of a device found by the user prior to patient use

B. Adverse event caused by patient conditions

C. Malfunction occurring before the end of service life of the medical device

D. Malfunction protection operated correctly

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?

A. Quality improvement

B. Quality assurance

C. Clinical affairs

D. Regulatory agency

Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.

What should the regulatory affairs professional do FIRST to meet the new requirement?

A. Contact the trade association for advice.

B. Communicate with the relevant internal departments.

C. Prepare documents for the files.

D. Request a permanent waiver from the new regulation.

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

A. Pre-clinical studies

B. Phase I clinical trials

C. Phase I and II clinical trials

D. Phase III clinical trials

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?

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

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

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

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

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

A. "Is the product profitable for the manufacturer?"

B. "Is the product better than currently available alternatives?"

C. "Has the product been approved for morand4nan 10 years?"

D. "Is the product an established gold standard?"

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A. In vitro studies show the product to be superior.

B. Government survey data indicate the product is superior.

C. Results of a three-year, post-market patient survey indicate the product is superior.

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

A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?

A. Plasma fractionation

B. Product distribution

C. Individual plasma donation

D. Plasma pooling