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The RAC-GS certification is a valuable credential for regulatory professionals who are looking to advance their careers in the field of regulatory affairs. Regulatory Affairs Certification (RAC) Global Scope certification is recognized around the world as a mark of excellence in the profession, and it is highly valued by employers and regulatory agencies. In addition, the certification provides regulatory professionals with access to a variety of networking and professional development opportunities through RAPS and other regulatory organizations.
NEW QUESTION # 38
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The
intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform either an identification study or a non-clinical qualification study.
- B. Perform a non-clinical qualification study, wait until the result is available, and then consider performing
an identification study. - C. Perform an identification study, wait until the result is available, and then consider performing a
non-clinical qualification study. - D. Perform both identification and non-clinical qualification studies concurrently.
Answer: C
NEW QUESTION # 39
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new
drug development. Despite differences in the manufacturing processes of the companies, both APIs meet
the current specifications. Which is the MOST appropriate information to include in the final submission
documents?
- A. Information deemed appropriate by the regulatory authority
- B. The process information and analytical result of Company Y API
- C. The process information and the comparative analytical result of APIs from both companies
- D. The process information and analytical result of Company X API
Answer: C
NEW QUESTION # 40
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. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application. - C. Review the regulatory guidelines to determine how to proceed.
- D. Consult with the legal department to discuss the best course of action.
Answer: A
NEW QUESTION # 41
After submission to the regulatory authority, a substantial error was found in the application. In order to
resolve this issue, what should be done FIRST?
- A. Verify the procedure in the regulation for the corrections.
- B. Inform upper management immediately.
- C. Contact the legal department and ask them how to proceed.
- D. Resubmit the entire package.
Answer: A
NEW QUESTION # 42
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 requirements
- B. Product registration
- C. Product formulation
- D. Product stability
Answer: D
NEW QUESTION # 43
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?
- A. Adverse event caused by patient conditions
- B. Deficiency of a device found by the user prior to patient use
- C. Malfunction protection operated correctly
- D. Malfunction occurring before the end of service life of the medical device
Answer: A
NEW QUESTION # 44
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - B. Summarize regulatory documents and history and provide the information to the management team.
- C. Obtain regulatory documents and history and provide the information to R&D.
- D. Obtain competitor research and provide the information to the management team.
Answer: B
NEW QUESTION # 45
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 # 46
Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study
with a new product intended to treat an acute life-threatening disease with less than optimal available
therapy?
- A. Placebo-controlled
- B. Cross-over
- C. Active-controlled
- D. Dose-ranging
Answer: B
NEW QUESTION # 47
A clinical study of a drug is completed to support a marketing approval application. According to ICH, how
long should a sponsor retain the clinical study essential documents?
- A. Three years after the last clinical study site was supplied with investigational drugs
- B. For at least two years after the last approval of an application in an ICH region
- C. Until the product has been discontinued from marketing in all ICH regions
- D. For a minimum of 10 years after completion of the clinical study
Answer: B
NEW QUESTION # 48
Company X and Company Y both have products for the treatment of rare genetic diseases. Company X
would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about
Company Y?
- A. Recruit a professional to gather confidential intelligence on Company Y.
- B. Perform a thorough library search to gather detailed information on Company Y.
- C. Request the needed information from the Board of Directors of Company Y.
- D. Enter into an agreement with Company Y to perform due diligence.
Answer: D
NEW QUESTION # 49
During the review of a design dossier, the reviewer asks why the company has only carried out a
top-down risk approach. The reviewer is referring to which of the following?
- A. Failure mode and effect analysis
- B. ISO 14971 risk analysis
- C. Fault tree analysis
- D. Hazard and operability study
Answer: B
NEW QUESTION # 50
An inspection of a manufacturing site determines that a number of manufacturing changes have been
implemented without obtaining the necessary regulatory clearance. Which of the following actions should
the regulatory affairs professional complete FIRST?
- A. Stop product manufacturing.
- B. Review the stability data for the changes.
- C. Establish validation procedures.
- D. Assess the impact of the changes.
Answer: A
NEW QUESTION # 51
According to WHO, what are the temperature and humidity conditions for a Zone IVb long-term stability
study?
- A. 30 C and 35% RH
- B. 30: C and 75% RH
- C. 25: C and 60% RH
- D. 30c C and 65% RH
Answer: B
NEW QUESTION # 52
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and
include instances of complete remission. The company has been granted patents in multiple countries for
the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential
problems for marketing of the product worldwide. Which of the following is the MOST important
consideration to discuss?
- A. International import and export regulations
- B. The stability of the drug in all zone conditions
- C. The time frame in which the patent will expire
- D. Doha Declaration in the TRIPS Agreement
Answer: B
NEW QUESTION # 53
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase III clinical trials
- B. Phase I and II clinical trials
- C. Pre-clinical studies
- D. Phase I clinical trials
Answer: A
NEW QUESTION # 54
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
Answer: B
NEW QUESTION # 55
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your
company?
- A. Document any failure to follow regulatory compliance processes in employee performance reviews.
- B. Train all new employees on regulatory compliance processes and assign a mentor to them.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train employees on all regulatory compliance processes using state-of-the-art systems.
Answer: C
NEW QUESTION # 56
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. Inform the company's senior management and arrange an emergency meeting
- B. Obtain a copy of the proposed regulation and analyze the impact.
- C. Arrange for additional testing of the product at the testing facility.
- D. Consult with the company's legal department regarding options.
Answer: B
NEW QUESTION # 57
A company is currently marketing an implantable orthopedic medical device. The R&D department is
planning to change the material used for the implant. The R&D department states that the change does
not impact the safety and effectiveness of the product. What action should the regulatory affairs
professional take FIRST?
- A. Prepare regulatory submissions that detail the medical device's change in materials.
- B. Review the content of change and supporting data for the equivalency with the current material.
- C. No action is needed in this situation.
- D. Write a memo to file since the change does not impact product safety and effectiveness.
Answer: B
NEW QUESTION # 58
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. Initiate a mandatory recall of the product in Country Y.
- B. Prepare the legal team in Country Y for possible litigations.
- C. Draft a formal letter to customers in Country Y about this recall.
- D. Review alt distribution records and complaints reported in Country Y.
Answer: D
NEW QUESTION # 59
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Consumer
- B. Distributor
- C. Regulatory authority
- D. Manufacturer
Answer: D
NEW QUESTION # 60
A company receives multiple complaints regarding the text included on a recently launched product's
label. What action should the regulatory affairs professional take FIRST?
- A. Inform the production team.
- B. Notify the regulatory authority.
- C. Compare the approved text with the product label
- D. Recommend an immediate product recall.
Answer: C
NEW QUESTION # 61
Why is it necessary to run supplemental safety pharmacology studies?
- A. To comply with regulatory authority requirements related to clinical studies
- B. To substitute the utilization of GLP
- C. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
- D. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
Answer: D
NEW QUESTION # 62
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