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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q36-Q41):

NEW QUESTION # 36
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

  • A. Review the regulatory guidelines to determine how to proceed.
  • B. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
  • C. Request a meeting with the regulatory authority to discuss the application.
  • D. Consult with the legal department to discuss the best course of action.

Answer: C


NEW QUESTION # 37
A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?

  • A. Use the Madrid system.
  • B. Use the community patent system.
  • C. File design patents in target countries.
  • D. File patents of interest in target countries.

Answer: D


NEW QUESTION # 38
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

  • A. Site license
  • B. Import license
  • C. Product license
  • D. Export license

Answer: A


NEW QUESTION # 39
Which of the following is NOT required to be included in a marketing application?

  • A. Administrative forms
  • B. Evidence of fee payment
  • C. Quality, safety, and efficacy Information
  • D. Final printed label

Answer: B


NEW QUESTION # 40
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 company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
  • B. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
  • C. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
  • D. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

Answer: D


NEW QUESTION # 41
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