RAPS Regulatory Affairs Certification (RAC) Global Scope

QUESTION NO: 1
After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

A. Add a warning in the IFU. B. Perform another risk-benefit analysis. C. Discontinue the project. D. Redesign the device.

Correct Answer: D

QUESTION NO: 2
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. Three years after the last clinical study site was supplied with investigational drugs B. Fora minimum of 10 years after completion of the clinical study C. For at least two years after the last approval of an application in an ICH region D. Until the product has been discontinued from marketing in all ICH regions

Correct Answer: C,D

QUESTION NO: 3
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

A. Fault tree analysis B. Failure modes, effects, and criticality analysis C. Fishbone analysis D. Quality by design analysis

Correct Answer: B

QUESTION NO: 4
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

A. Deleting an ingredient of the drug product B. Strengthening a precaution to the product labeling C. Deleting a drug substance D. Introducing a new analytical method

Correct Answer: B

QUESTION NO: 5
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

A. Inadequate training B. Late and/or incorrect deliverables C. Adverse environmental impacts D. Causes of non-conformities

Correct Answer: D

QUESTION NO: 6
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 pooling B. Individual plasma donation C. Plasma fractionation D. Product distribution

Correct Answer: D

QUESTION NO: 7
Which of the following BEST describes the purpose of the ICH?

A. To lobby for improved industry standards for the development of new safe, effective, andhigh-quality medicines for the ICH regions B. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions C. To protect and promote public health through the evaluation and supervision of safe,effective, and high-quality medicines for the ICH regions D. To provide scientific evaluation of applications for international marketing authorization forsafe, effective, and high-quality medicines for the ICH regions

Correct Answer: B

QUESTION NO: 8
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

A. Product registration B. Product stability C. Product requirements D. Product formulation

Correct Answer: B

QUESTION NO: 9
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. Efficacy and material D. Safety and efficacy

Correct Answer: B

QUESTION NO: 10
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. Consult with the company's legal department regarding options. B. Obtain a copy of the proposed regulation and analyze the impact. C. Inform the company's senior management and arrange an emergency meeting D. Arrange for additional testing of the product at the testing facility.

Correct Answer: B

RAPS Regulatory Affairs Certification (RAC) Global Scope - RAC-GS Exam Questions