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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q71-Q76):

NEW QUESTION # 71
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 regions
B. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
C. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
D. 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 # 72
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

A. Introduction of the API starting material
B. Physical processing and packaging
C. Isolation and purification
D. Production of Intermediate(s)

Answer: B

NEW QUESTION # 73
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

A. Risk control
B. Risk estimation
C. Risk analysis
D. Risk management

Answer: C

NEW QUESTION # 74
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

A. Vigilance procedure to ensure the full traceability of the products
B. Systematic procedure to review experiences with the products in use
C. Systematic procedure to review published scientific journals
D. Vigilance procedure to notify the regulatory authorities about serious incidents

Answer: A

NEW QUESTION # 75
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 a minimum of 10 years after completion of the clinical study
B. Three years after the last clinical study site was supplied with investigational drugs
C. Until the product has been discontinued from marketing in all ICH regions
D. For at least two years after the last approval of an application in an ICH region

Answer: D

NEW QUESTION # 76
……

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q71-Q76):

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