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The targeted audience for the RAPS RAC-US certification exam is regulatory professionals involved in the pharmaceutical and medical device industries. However, candidates from any related field can take the RAPS RAC-US exam provided that they have sufficient knowledge in the area of medical devices and pharmaceuticals regulations. Individuals having designations like Pharmacist, Regulatory Scientist, Medical Device Regulatory Specialist, etc. may also apply. The RAC-US exam dumps say that Senior managers with the ability to make recommendations for a particular company's products and services are also eligible to take the exam. Chat with us now to learn more about the eligibility requirements and other requirements for this certification exam.

RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q61-Q66):


In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

  • A. Previous actions taken by regulatory authorities on similar products
  • B. Capacity of the manufacturing facilities to fully produce the new product
  • C. Potential clinical sites for the Phase III clinical trial
  • D. Regulatory requirements for labeling and packaging

Answer: A


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

Answer: B


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. Until the product has been discontinued from marketing in all ICH regions
  • B. For a 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. Three years after the last clinical study site was supplied with investigational drugs

Answer: C


A company is developing a new medical device.

During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

  • A. Product release and validation
  • B. Concept development and validation
  • C. Concept development and early technical design
  • D. Early technical design and product release

Answer: C


Which of the following is MOST appropriate for the purpose of lot release of biologics?

  • A. Safety assurance
  • B. Quality verification
  • C. Inventory control
  • D. Efficacy confirmation

Answer: B



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