RAC Regulatory Affairs Certification RAC-GS Dumps | Updated Dec 05, 2021 - ExamTorrent
Master 2021 Latest The Questions RAC Regulatory Affairs Certification and Pass RAC-GS Real Exam!
NEW QUESTION 13
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?
- A. Class B
- B. Class A
- C. Class D
- D. Class C
Answer: D
NEW QUESTION 14
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. Marketing materials
- C. Clinical trial data
- D. Safety issues
Answer: D
NEW QUESTION 15
According to the ICH guideline on GMP for API, to which of the following is the MOST stringent
requirement applied?
- A. Production of Intermediate(s)
- B. Isolation and purification
- C. Physical processing and packaging
- D. Introduction of the API starting material
Answer: C
NEW QUESTION 16
A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Obtain a copy of the proposed regulation and analyze the impact.
- B. Consult with the company's legal department regarding options.
- C. Inform the company's senior management and arrange an emergency meeting
- D. Arrange for additional testing of the product at the testing facility.
Answer: A
NEW QUESTION 17
The API used for an approved drug product conforms to international monograph specifications and local
pharmacopeia; however, the international monograph specifications of the API will be changing soon.
Which is the most appropriate action for the regulatory affairs professional to take FIRST?
- A. Prepare the international monograph change submission first and then prepare the local change when
required. - B. Transfer the notice of the upcoming international monograph change to QA for further processing.
- C. Analyze the impact of the international monograph change on the local pharmacopeia.
- D. Confirm that the international monograph change is not related to local pharmacopeia.
Answer: B
NEW QUESTION 18
In preparation for the development of a new line of products, a regulatory affairs professional is asked to
prepare a short presentation for senior management. Which of the following topics is MOST important to
cover?
- A. Potential clinical sites for the Phase III clinical trial
- B. Capacity of the manufacturing facilities to fully produce the new product
- C. Previous actions taken by regulatory authorities on similar products
- D. Regulatory requirements for labeling and packaging
Answer: C
NEW QUESTION 19
Which of the following is the PRIMARY purpose of an audit report?
- A. To document compliance history
- B. To define how to prepare new product submissions
- C. To train sales representatives
- D. To carry out a complete review of product applications
Answer: A
NEW QUESTION 20
A process is ultimately validated to ensure which of the following?
- A. The process consistently meets the desired Quantity standards
- B. The process meets the quality system requirements.
- C. The process consistently produces the desired results.
- D. The process meets the regulatory requirements.
Answer: C
NEW QUESTION 21
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. Request a meeting with the regulatory authority to discuss the application.
- B. Consult with the legal department to discuss the best course of action.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application. - D. Review the regulatory guidelines to determine how to proceed.
Answer: A
NEW QUESTION 22
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. 30c C and 65% RH
- C. 30 C and 35% RH
- D. 30: C and 75% RH
Answer: D
NEW QUESTION 23
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation
based on which of the following?
- A. Risk analysis
- B. Instructions for use
- C. Product literature
- D. Essential principles
Answer: A
NEW QUESTION 24
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject's hospitalization is due to an unscheduled hip operation.
- B. Subject's hospitalization is prolonged during the clinical trial.
- C. Subject is hospitalized due to complications of the product administration.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION 25
Which term does NOT describe the same concept as the others?
- A. Monoclonal antibody
- B. Follow-on protein products
- C. Biosimilars
- D. Subsequent entry biologics
Answer: A
NEW QUESTION 26
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your
company?
- A. Train all new employees on regulatory compliance processes and assign a mentor to them.
- B. Develop documented procedures for regulatory compliance processes and train personnel.
- C. Train employees on all regulatory compliance processes using state-of-the-art systems.
- D. Document any failure to follow regulatory compliance processes in employee performance reviews.
Answer: B
NEW QUESTION 27
A company is developing a line of products for which no ISO standard of performance is available. As a
result, the company wishes to propose developing such a standard. Whom should the company contact in
order to start the development of the new standard?
- A. The ISO national member body
- B. The ISO technical committee in charge of the area
- C. The ISO Secretariat
- D. The country's regulatory authority
Answer: A
NEW QUESTION 28
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be sold or offered for sale in domestic commerce.
- B. The product must not be in conflict with the laws of the country to which it is intended for export.
- C. The product must not be labeled on the outside of the shipping package that it is intended for export.
- D. The product must not be in accord with the specifications of the foreign purchaser.
Answer: B
NEW QUESTION 29
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