RAPS RAC Regulatory Affairs Certification RAC-GS Questions & Answers

• Question 91:

  According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

  A. Deficiency of a device found by the user prior to patient use

  B. Adverse event caused by patient conditions

  C. Malfunction occurring before the end of service life of the medical device

  D. Malfunction protection operated correctly

  Correct Answer: BC

• Question 92:

  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

  Correct Answer: C

• Question 93:

  A process is ultimately validated to ensure which of the following?

  A. The process meets the regulatory requirements.

  B. The process meets the quality system requirements.

  C. The process consistently produces the desired results.

  D. The process consistently meets the desiredQuantity standards

  Correct Answer: C

• Question 94:

  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."

  Correct Answer: B

• Question 95:

  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

  Correct Answer: A

• Question 96:

  Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

  A. Utilize the STED template to complete global requirements.

  B. Initiate a global submission process after all submission data are finalized.

  C. Identify countries where special requirements exist during the product development phase.

  D. Plan regulatory approval update meetings with senior management and stakeholders.

  Correct Answer: C

• Question 97:

  A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.

  To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

  A. Label the product for use in appropriate populations.

  B. Educate patients and healthcare providers on how to use the product

  C. Delay product launch until required studies are completed.

  D. Promote off-label use to a carefully selected patient population.

  Correct Answer: D

• Question 98:

  A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a medical device. The same product, without theantibiotics and biologics, is marketed as a medical device in Country Y. The company is proposing to start marketing the coated device in Country Y. Which regulatory approach should the company propose?

  A. Submit the product for review as a pharmaceutical product in Country Y.

  B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

  C. Apply for review of the additional part of the product as a pharmaceutical product in Country

  D. Examine decisions made about similar products in Country Y to propose the classification ofthe product.

  Correct Answer: CD

• Question 99:

  Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.

  Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

  A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.

  B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.

  C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.

  D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.

  Correct Answer: A

• Question 100:

  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.

  Correct Answer: D