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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q77-Q82):

NEW QUESTION # 77
Which of the following BEST describes the purpose of the ICH?

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

Answer: A

NEW QUESTION # 78
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

A. Compatibility and safetyB. Volume and materialC. Efficacy and materialD. Safety and efficacy

Answer: A

NEW QUESTION # 79
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?

A. SpecificationB. PropertyC. FormulationD. Justification

Answer: D

NEW QUESTION # 80
A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

A. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.B. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.C. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.D. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.

Answer: B

NEW QUESTION # 81
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

A. The manufacturer's experience level with the type of IVD medical device is limited.B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.C. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.D. The device incorporates well-established technology that is already present in the market.

Answer: A

NEW QUESTION # 82
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