RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 1:

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

• Question 2:

  A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

  A. Documented agreement
  B. Frequent communication
  C. Early collaboration
  D. Follow-up meeting after submission
  B. Frequent communication

• Question 3:

  Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

  A. Conduct a Phase III study for a new unrelated indication of the drug.
  B. Develop a generic version of the drug.
  C. Develop a better brand-name drug in the same class.
  D. Explore litigation strategy for patent infringements on the drug.
  B. Develop a generic version of the drug.

• Question 4:

  Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB?

  A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
  B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
  C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
  D. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation
  D. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation

• Question 5:

  As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address

  the issue?

  A. Inform the regulatory authorities.
  B. Delay the start of product production.
  C. Correct the label text.
  D. Abort the product launch.
  A. Inform the regulatory authorities.

• Question 6:

  Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

  A. Proposed dose and volume of administration
  B. Biological activity with species and/or tissue specificity
  C. Immunochemical and functional tests
  D. Proposed product route and frequency of administration
  B. Biological activity with species and/or tissue specificity

• Question 7:

  A company is developing a new line of products in an area that is new to the company. What is the BEST approach?

  A. Ask the trade association representative to provide an overview of the new product area to the marketing team.
  B. Obtain competitor research and provide the information to the management team.
  C. Obtain regulatory documents and history and provide the information to RandD.
  D. Summarize regulatory documents and history and provide the information to the management team.
  D. Summarize regulatory documents and history and provide the information to the management team.

• Question 8:

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

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

• Question 9:

  Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.

  What should the regulatory affairs professional do FIRST to meet the new requirement?

  A. Contact the trade association for advice.
  B. Communicate with the relevant internal departments.
  C. Prepare documents for the files.
  D. Request a permanent waiver from the new regulation.
  B. Communicate with the relevant internal departments.

• Question 10:

  A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

  A. Doha Declaration in the TRIPS Agreement
  B. The stability of the drug in all zone conditions
  C. The time frame in which the patent will expire
  D. International import and export regulations
  B. The stability of the drug in all zone conditions