RAPS RAC-GS Online Practice Questions and Exam Preparation

RAPS RAC-GS Online Questions & Answers

• Question 21:

  According to WHO,what are the temperature and humidity conditions for a Zone IVb long- term stability study?

  A. 25: C and 60% RH
  B. 30?C and 35% RH
  C. 30c C and 65% RH
  D. 30: C and 75% RH
  D. 30: C and 75% RH

• Question 22:

  A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.

  During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.

  What is the BEST response?

  A. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
  B. Consult with the legal department to discuss the best course of action.
  C. Review the regulatory guidelines to determine how to proceed.
  D. Request a meeting with the regulatory authority to discuss the application.
  D. Request a meeting with the regulatory authority to discuss the application.

• Question 23:

  A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product. What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

  A. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
  B. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
  C. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
  D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
  A. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
  D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.

• Question 24:

  In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

  A. Product stability
  B. Product registration
  C. Product formulation
  D. Product requirements
  A. Product stability

• Question 25:

  According to ICH, which of the following components of study information is NOT required in a clinical study report?

  A. Randomization scheme and codes
  B. Protocol and protocol amendments
  C. ListoflECsorlRBs
  D. Detailed CVofall investigators
  D. Detailed CVofall investigators

• Question 26:

  A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?

  A. Expiration date
  B. Relevance to regulations
  C. Revision history
  D. Scope and level of detail
  B. Relevance to regulations

• Question 27:

  Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

  A. Deleting an ingredient of the drug product
  B. Deleting a drug substance
  C. Introducing a new analytical method
  D. Strengthening a precaution to the product labeling
  D. Strengthening a precaution to the product labeling

• Question 28:

  The requirements for document control are located in which of the following documents?

  A. ICH guidelines
  B. IEC 60601
  C. ISO 13485
  D. WHO guidelines
  C. ISO 13485

• Question 29:

  During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

  A. Allow doctors to use the product for the off-label indication.
  B. Communicate with the sales department to stop using the promotional materials.
  C. Contact the marketing department to recall the product.
  D. Request that doctors stop using the product for the off-label indication.
  B. Communicate with the sales department to stop using the promotional materials.

• Question 30:

  The regulatory authority in Country X issued a request for a mandatory product recall in Country X due to serious injuries to patients. This product also is distributed in Country Y. What should the regulatory affairs professional of the product's manufacturer FIRST do in Country Y?

  A. Draft a formal letter to customers in Country Y about this recall.
  B. Initiate a mandatory recall of the product in Country Y.
  C. Review alt distribution records and complaints reported in Country Y.
  D. Prepare the legal team in Country Y for possible litigations.
  C. Review alt distribution records and complaints reported in Country Y.