RAC-US Online Practice Questions and Answers

A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y. The company is proposing to start marketing the coated device in Country Y. Which regulatory approach should the company propose?

A. Submit the product for review as a pharmaceutical product in Country Y.

B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

C. Apply for review of the additional part of the product as a pharmaceutical product in Country

D. Examine decisions made about similar products in Country Y to propose the classification ofthe product.

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

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.

Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A. Systematic procedure to review published scientific journals

B. Systematic procedure to review experiences with the products in use

C. Vigilance procedure to ensure the full traceability of the products

D. Vigilance procedure to notify the regulatory authorities about serious incidents

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

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.

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?

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

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

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

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

A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

A. Obtain a copy of the proposed regulation and analyze the impact.

B. Inform the company's senior management and arrange an emergency meeting

C. Consult with the company's legal department regarding options.

D. Arrange for additional testing of the product at the testing facility.

During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

A. Increase the frequency of monitoring visits.

B. Inform the institution that granted a medical license to the Pi.

C. Send a letter of complaint to the Ethics Committee that approved the site.

D. Terminate the PI and inform the regulatory authorities.

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

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 forexport.

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

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

A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

A. Doha Declaration in the TRIPS Agreement

B. The stability of the drug in all zone conditions

C. The time frame in which the patent will expire

D. International import and export regulations

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

A clinical study of a drug is completed to support a marketing approval application. According to ICH,how long should a sponsor retain the clinical study essential documents?

A. For at least two years after the last approval of an application in an ICH region

B. Fora minimum of 10 years after completion of the clinical study

C. Three years after the last clinical study site was supplied with investigational drugs

D. Until the product has been discontinued from marketing in all ICH regions

The requirements for document control are located in which of the following documents?

A. ICH guidelines

B. IEC 60601

C. ISO 13485

D. WHO guidelines

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Safety and failure risk

B. Safety and effectiveness

C. Quality and failure risk

D. Quality and effectiveness