RAC-GS Online Practice Questions and Answers

A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.

To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

A. Label the product for use in appropriate populations.

B. Educate patients and healthcare providers on how to use the product

C. Delay product launch until required studies are completed.

D. Promote off-label use to a carefully selected patient population.

According to WHO,what are the temperature and humidity conditions for a Zone IVb long- term stability study?

A. 25: C and 60% RH

B. 30?C and 35% RH

C. 30c C and 65% RH

D. 30: C and 75% RH

Which of the following BEST describes the purpose of the ICH?

A. To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions

B. To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions

C. To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions

D. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A. Allow doctors to use the product for the off-label indication.

B. Communicate with the sales department to stop using the promotional materials.

C. Contact the marketing department to recall the product.

D. Request that doctors stop using the product for the off-label indication.

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.

A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

A. Adverse event reports

B. Clinical experience

C. Clinical investigations

D. Literature search

According to the ICH guideline on GMP for API,to which of the following is the MOST stringent requirement applied?

A. Physical processing and packaging

B. Isolation and purification

C. Production of Intermediate(s)

D. Introduction of the API starting material

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?

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.

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

A. Module 1

B. Module 2

C. Module 3

D. Module 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. Stop product manufacturing.

B. Establish validation procedures.

C. Assess the impact of the changes.

D. Review the stability data for the changes.