RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 61:

  Which of the following is the PRIMARY purpose of an audit report?

  A. To carry out a complete review of product applications
  B. To define how to prepare new product submissions
  C. Todocument compliance history
  D. To train sales representatives
  C. Todocument compliance history

• Question 62:

  Which of the following situations does NOT require rapid communication to regulatory authorities?

  A. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
  B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
  C. A major safety finding from a newly completed animal carcinogenicity study
  D. A statistically significant increase in the number of deaths in an animal dose finding study
  A. A clinically important increase in the rate of occurrence of an "expected." but serious ADR
  D. A statistically significant increase in the number of deaths in an animal dose finding study

• Question 63:

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

• Question 64:

  Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

  A. Utilize the STED template to complete global requirements.
  B. Initiate a global submission process after all submission data are finalized.
  C. Identify countries where special requirements exist during the product development phase.
  D. Plan regulatory approval update meetings with senior management and stakeholders.
  C. Identify countries where special requirements exist during the product development phase.

• Question 65:

  A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation. What should be done. What action should the company take FIRST?

  A. Initiate testing immediately to ensure compliance.
  B. Consult with colleagues about the request.
  C. Contact the regulatory authority that issued this request and discuss the requirement.
  D. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
  C. Contact the regulatory authority that issued this request and discuss the requirement.

• Question 66:

  Which of the following is NOT required to be included in a marketing application?

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

• Question 67:

  Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer. What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

  A. Enter into an agreement with Company Y to perform due diligence.
  B. Recruit a professional to gather confidential intelligence on Company Y.
  C. Request the needed information from the Board of Directors of Company Y.
  D. Perform a thorough library search to gather detailed information on Company Y.
  A. Enter into an agreement with Company Y to perform due diligence.

• Question 68:

  The safety database for an anti-hypertensive drug consists of the following: 461 patients exposed for three months 343 patients exposed for six months 112 patients exposed for nine months 74 patients exposed for 12 months Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

  A. 100 patients for 12 months
  B. 200 patients for nine months
  C. 500 patients for three months
  D. 3.000 total patient exposures
  A. 100 patients for 12 months

• Question 69:

  When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

  A. Pre-clinical studies
  B. Phase I clinical trials
  C. Phase I and II clinical trials
  D. Phase III clinical trials
  D. Phase III clinical trials

• Question 70:

  During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?

  A. ISO 14971 risk analysis
  B. Failure mode and effect analysis
  C. Fault tree analysis
  D. Hazard and operability study
  A. ISO 14971 risk analysis