RAPS RAPS Certifications RAC-US Questions & Answers

• Question 31:

  According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

  A. Class A

  B. Class B

  C. Class C

  D. Class D

  Correct Answer: C

• Question 32:

  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.

  Correct Answer: A

• Question 33:

  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

  Correct Answer: BC

• Question 34:

  During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

  A. ISO 14971 risk analysis

  B. Failure mode and effect analysis

  C. Fault tree analysis

  D. Hazard and operability study

  Correct Answer: A

• Question 35:

  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.

  Correct Answer: AB

• Question 36:

  In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

  A. Volume and material

  B. Compatibility and safety

  C. Safety and efficacy

  D. Efficacy and material

  Correct Answer: B

• Question 37:

  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

  Correct Answer: A

• Question 38:

  A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

  A. Labeling

  B. Regulatory application summary

  C. Risk management process

  D. Safety-related reporting

  Correct Answer: A

• Question 39:

  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

  Correct Answer: B

• Question 40:

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

  A. Consumer

  B. Distributor

  C. Manufacturer

  D. Regulatory authority

  Correct Answer: C