RAPS RAPS Certifications RAC-US Questions & Answers

• Question 61:

  The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

  A. Production

  B. Analytical

  C. Quality

  D. Regulatory

  Correct Answer: CD

• Question 62:

  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.

  Correct Answer: B

• Question 63:

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

  A. Inventory control

  B. Safety assurance

  C. Efficacy confirmation

  D. Quality verification

  Correct Answer: D

• Question 64:

  Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

  A. Before the enactment of the regulation, through the industry representative

  B. Before the enactment of the regulation, through formal comments gathering process

  C. After the enactment of the regulation, through the industry representative

  D. After the enactment of the regulation, through a product-specific meeting

  Correct Answer: B

• Question 65:

  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 66:

  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 67:

  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 68:

  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 69:

  Company X is planning to acquire the rights for a product marketed by Company Y. As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?

  A. Intellectual properly

  B. Clinical trial data

  C. Safety issues

  D. Marketing materials

  Correct Answer: C

• Question 70:

  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