RAPS RAPS Certifications RAC-GS Questions & Answers

• Question 61:

  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

  Correct Answer: D

• Question 62:

  You discover that your company's top selling product in the last two years has been used off-label. The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?

  A. Discuss with regulatory authorities to investigate how to have the off-label indication approved.

  B. No action is required since it is an off-label use.

  C. Advise the senior management to send a "Dear Dr." letter.

  D. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.

  Correct Answer: A

• Question 63:

  Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?

  A. Subject is hospitalized due to complications of the product administration.

  B. Subject is hospitalized for the purpose of product administration.

  C. Subject's hospitalization is due to an unscheduled hip operation.

  D. Subject's hospitalization is prolonged during the clinical trial.

  Correct Answer: BC

• Question 64:

  Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

  A. "Is the product profitable for the manufacturer?"

  B. "Is the product better than currently available alternatives?"

  C. "Has the product been approved for morand4nan 10 years?"

  D. "Is the product an established gold standard?"

  Correct Answer: B

• Question 65:

  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

  Correct Answer: AD

• Question 66:

  A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the WHO recommendations?

  A. Certificate of GMP

  B. Certificate of Free Sale

  C. Certificate of Pharmaceutical Product

  D. Certificate of Analysis for the finished product

  Correct Answer: C

• Question 67:

  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.

  Correct Answer: D

• Question 68:

  A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?

  A. Review the company's existing Quality ManagementSystem

  B. Reformulate the products with a replacement material.

  C. Qualify another supplier and execute a supplier agreement.

  D. Complete a gap analysis to identify options.

  Correct Answer: CD

• Question 69:

  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

  Correct Answer: C

• Question 70:

  According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

  A. 3

  B. 5

  C. 10

  D. 15

  Correct Answer: BCD