RAC-US Actual Questions Answers Pass With Real RAC-US Exam Dumps [Q37-Q60]

Rate this post

RAC-US Actual Questions Answers Pass With Real RAC-US Exam Dumps

RAC-US Dumps Prepare Your Exam With 100 Questions

The regulatory affairs industry is a critical part of the healthcare sector that ensures the safety and efficacy of medical products. The regulatory affairs professionals are responsible for navigating the complex regulatory landscape and ensuring that all products meet the required standards before they are released to the market. The regulatory affairs professionals play a vital role in ensuring that the healthcare products undergo rigorous testing and are safe for use by patients. One way to demonstrate proficiency in regulatory affairs is by obtaining the Regulatory Affairs Certification (RAC) US certification.

RAPS RAC-US (Regulatory Affairs Certification (RAC) US) Certification Exam is a professional certification program for regulatory affairs professionals in the United States. It is designed to test the knowledge and skills required to succeed in regulatory affairs roles, and is recognized as a mark of excellence in the industry. RAC-US exam is offered by the Regulatory Affairs Professionals Society (RAPS), a global membership organization for regulatory professionals.

Q37. 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?

Perform either an identification study or a non-clinical qualification study.

Perform both identification and non-clinical qualification studies concurrently.

Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.

Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

Q38. After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

Add a warning in the IFU.

Discontinue the project.

Perform another risk-benefit analysis.

Redesign the device.

Q39. 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?

The ISO national member body

The ISO technical committee in charge of the area

The ISO Secretariat

The country’s regulatory authority

Q40. During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?

Increase the frequency of monitoring visits.

Inform the institution that granted a medical license to the Pi.

Send a letter of complaint to the Ethics Committee that approved the site.

Terminate the PI and inform the regulatory authorities.

Q41. Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

Deleting an ingredient of the drug product

Deleting a drug substance

Introducing a new analytical method

Strengthening a precaution to the product labeling

Q42. 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?

Active-controlled

Cross-over

Dose-ranging

Placebo-controlled

Q43. Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

Fishbone analysis

Failure modes, effects, and criticality analysis

Fault tree analysis

Quality by design analysis

Q44. Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?

The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.

Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.

The manufacturer’s experience level with the type of IVD medical device is limited.

The device incorporates well-established technology that is already present in the market.

Q45. 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?

Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.

Consult with the legal department to discuss the best course of action.

Review the regulatory guidelines to determine how to proceed.

Request a meeting with the regulatory authority to discuss the application.

Q46. 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?

Stop product manufacturing.

Establish validation procedures.

Assess the impact of the changes.

Review the stability data for the changes.

Q47. Which of the following situations does NOT require rapid communication to regulatory authorities?

A clinically important increase in the rate of occurrence of an “expected.” but serious
ADR

A lack of efficacy with a medicinal product used in treating a life-threatening disease

A major safety finding from a newly completed animal carcinogenicity study

A statistically significant increase in the number of deaths in an animal dose finding study

Q48. Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

Conduct a Phase III study for a new unrelated indication of the drug.

Develop a generic version of the drug.

Develop a better brand-name drug in the same class.

Explore litigation strategy for patent infringements on the drug.

Q49. 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?

Obtain a copy of the proposed regulation and analyze the impact.

Inform the company’s senior management and arrange an emergency meeting

Consult with the company’s legal department regarding options.

Arrange for additional testing of the product at the testing facility.

Q50. Which of the following is MOST appropriate for the purpose of lot release of biologics?

Inventory control

Safety assurance

Efficacy confirmation

Quality verification

Q51. 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?

Quality improvement

Quality assurance

Clinical affairs

Regulatory agency

Q52. According to WHO, what are the temperature and humidity conditions for a Zone IVb long- term stability study?

25: C and 60% RH

30 C and 35% RH

30c C and 65% RH

30: C and 75% RH

Q53. SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

Inadequate training

Late and/or incorrect deliverables

Causes of non-conformities

Adverse environmental impacts

Q54. 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?

Draft a formal letter to customers in Country Y about this recall.

Initiate a mandatory recall of the product in Country Y.

Review alt distribution records and complaints reported in Country Y.

Prepare the legal team in Country Y for possible litigations.

Q55. According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

Physical processing and packaging

Isolation and purification

Production of Intermediate(s)

Introduction of the API starting material

Q56. 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?

Utilize the STED template to complete global requirements.

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

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

Plan regulatory approval update meetings with senior management and stakeholders.

Q57. The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?

100 patients for 12 months

200 patients for nine months

500 patients for three months

3.000 total patient exposures

Q58. A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?

Labeling

Regulatory application summary

Risk management process

Safety-related reporting

Q59. A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?

Initiate testing immediately to ensure compliance.

Consult with colleagues about the request.

Contact the regulatory authority that issued this request and discuss the requirement.

Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.

Q60. 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?

Intellectual properly

Clinical trial data

Safety issues

Marketing materials

Loading …