RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 11:

  A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

  A. Adverse event reports
  B. Clinical experience
  C. Clinical investigations
  D. Literature search
  C. Clinical investigations

• Question 12:

  Why is it necessary to run supplemental safety pharmacology studies?

  A. To substitute the utilization of GLP
  B. To comply with regulatory authority requirements related to clinical studies
  C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
  D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
  C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery

• Question 13:

  What is the LAST stage in the development of a quality risk management process for a medical device?

  A. Risk analysis
  B. Risk reduction
  C. Risk acceptance
  D. Risk evaluation
  C. Risk acceptance

• Question 14:

  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
  C. Certificate of Pharmaceutical Product

• Question 15:

  Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

  A. "Product X is a guaranteed cure for arthritis."
  B. "Product X is effective for the treatment of arthritis."
  C. "Product X is safe for arthritis and without side effects."
  D. "Product X is effective in all patients with arthritis."
  B. "Product X is effective for the treatment of arthritis."

• Question 16:

  During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

  A. The minimum number of attendees necessary to address the issues
  B. All senior management from the main office
  C. As many as government attendees
  D. As many as required by international standards
  A. The minimum number of attendees necessary to address the issues

• Question 17:

  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
  C. Quality
  D. Regulatory

• Question 18:

  At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

  A. Quality improvement
  B. Quality assurance
  C. Clinical affairs
  D. Regulatory agency
  B. Quality assurance

• Question 19:

  Which term does NOT describe the same concept as the others?

  A. Biosimilars
  B. Follow-on protein products
  C. Monoclonal antibody
  D. Subsequent entry biologics
  C. Monoclonal antibody

• Question 20:

  During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally. Which of the following is the most appropriate action to take FIRST?

  A. Withdraw the affected product from the markets.
  B. Send a "Dear Dr." letter to customers.
  C. Notify the global regulatory authorities.
  D. Assess the potential safety risk.
  C. Notify the global regulatory authorities.