Most UptoDate RAPS RAC-US Exam Dumps PDF 2021
100% Free RAC Regulatory Affairs Certification RAC-US Dumps PDF Demo Cert Guide Cover
NEW QUESTION 47
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
- A. A brief summary of relevant physical, chemical, and pharmaceutical properties:
instructions for storage and handling of the dosage form: and a description of the formulation - B. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
- C. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
- D. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation
Answer: A
NEW QUESTION 48
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?
- A. Determination of product design deliverables
- B. Determination of primary mode of action
- C. Approved indications of the drug
- D. Guidance documents for the device
Answer: A
NEW QUESTION 49
A process is ultimately validated to ensure which of the following?
- A. The process consistently produces the desired results.
- B. The process consistently meets the desired Quantity standards
- C. The process meets the regulatory requirements.
- D. The process meets the quality system requirements.
Answer: A
NEW QUESTION 50
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
- A. Proposed dose and volume of administration
- B. Proposed product route and frequency of administration
- C. Biological activity with species and/or tissue specificity
- D. Immunochemical and functional tests
Answer: C
NEW QUESTION 51
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Withdraw the affected product from the markets.
- B. Notify the global regulatory authorities.
- C. Assess the potential safety risk.
- D. Send a "Dear Dr." letter to customers.
Answer: B
NEW QUESTION 52
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 4
- B. Module 3
- C. Module 2
- D. Module 1
Answer: C
NEW QUESTION 53
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
- A. Quality by design analysis
- B. Failure modes, effects, and criticality analysis
- C. Fishbone analysis
- D. Fault tree analysis
Answer: B
NEW QUESTION 54
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. Educate patients and healthcare providers on how to use the product
- B. Label the product for use in appropriate populations.
- C. Delay product launch until required studies are completed.
- D. Promote off-label use to a carefully selected patient population.
Answer: D
NEW QUESTION 55
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company's products. What action should the company take FIRST?
- A. Review the company's existing Quality Management System
- B. Complete a gap analysis to identify options.
- C. Reformulate the products with a replacement material.
- D. Qualify another supplier and execute a supplier agreement.
Answer: D
NEW QUESTION 56
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
- A. Acknowledge receipt of the letter in a written response but do nothing further.
- B. Inform the local regulatory authority of the letter and discuss how to respond.
- C. Inform Company X that it has no right to send such a letter and do nothing further.
- D. Inform the legal department of the letter and discuss how to respond.
Answer: D
NEW QUESTION 57
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. Marketing materials
- B. Clinical trial data
- C. Safety issues
- D. Intellectual properly
Answer: C
NEW QUESTION 58
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?
- A. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 59
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
- A. Systematic procedure to review published scientific journals
- B. Systematic procedure to review experiences with the products in use
- C. Vigilance procedure to ensure the full traceability of the products
- D. Vigilance procedure to notify the regulatory authorities about serious incidents
Answer: C
NEW QUESTION 60
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?
- A. Add a warning in the IFU.
- B. Perform another risk-benefit analysis.
- C. Discontinue the project.
- D. Redesign the device.
Answer: D
NEW QUESTION 61
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: B
NEW QUESTION 62
The requirements for document control are located in which of the following documents?
- A. ISO 13485
- B. WHO guidelines
- C. ICH guidelines
- D. IEC 60601
Answer: A
NEW QUESTION 63
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Efficacy confirmation
- B. Quality verification
- C. Inventory control
- D. Safety assurance
Answer: B
NEW QUESTION 64
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
- A. Adverse event reports
- B. Clinical investigations
- C. Clinical experience
- D. Literature search
Answer: B
NEW QUESTION 65
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 X API
- C. The process information and the comparative analytical result of APIs from both companies
- D. The process information and analytical result of Company Y API
Answer: C
NEW QUESTION 66
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
- A. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- B. In vitro studies show the product to be superior.
- C. Government survey data indicate the product is superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
Answer: A
NEW QUESTION 67
Which of the following BEST describes the purpose of the ICH?
- A. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
- B. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
- C. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions
- D. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
Answer: C
NEW QUESTION 68
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Manufacturer
- B. Consumer
- C. Regulatory authority
- D. Distributor
Answer: A
NEW QUESTION 69
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