Free RAPS RAC-US Exam Questions and Answer from Training Expert PassReview
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NEW QUESTION # 11
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?
- A. Certificate of Free Sale
- B. Certificate of GMP
- C. Certificate of Analysis for the finished product
- D. Certificate of Pharmaceutical Product
Answer: D
NEW QUESTION # 12
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Request documentation from the sub-contractor.
- B. Ask the vendor to take responsibility.
- C. Document and perform audits.
- D. Request an inspection from a regulatory authority.
Answer: C
NEW QUESTION # 13
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. Terminate the PI and inform the regulatory authorities.
- B. Send a letter of complaint to the Ethics Committee that approved the site.
- C. Inform the institution that granted a medical license to the Pi.
- D. Increase the frequency of monitoring visits.
Answer: A
NEW QUESTION # 14
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?
- A. Regulatory application summary
- B. Risk management process
- C. Labeling
- D. Safety-related reporting
Answer: C
NEW QUESTION # 15
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 # 16
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?
- A. Risk estimation
- B. Risk management
- C. Risk control
- D. Risk analysis
Answer: D
NEW QUESTION # 17
According to ICH, which of the following components of study information is NOT required in a clinical study report?
- A. List of lECs or lRBs
- B. Randomization scheme and codes
- C. Detailed CV of all investigators
- D. Protocol and protocol amendments
Answer: C
NEW QUESTION # 18
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. Redesign the device.
- B. Discontinue the project.
- C. Add a warning in the IFU.
- D. Perform another risk-benefit analysis.
Answer: A
NEW QUESTION # 19
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Product distribution
- C. Plasma fractionation
- D. Individual plasma donation
Answer: B
NEW QUESTION # 20
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 # 21
Which of the following is NOT required to be included in a marketing application?
- A. Final printed label
- B. Administrative forms
- C. Evidence of fee payment
- D. Quality, safety, and efficacy Information
Answer: C
NEW QUESTION # 22
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. Previous actions taken by regulatory authorities on similar products
- C. Regulatory requirements for labeling and packaging
- D. Capacity of the manufacturing facilities to fully produce the new product
Answer: B
NEW QUESTION # 23
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
- A. Vigilance procedure to ensure the full traceability of the products
- B. Systematic procedure to review experiences with the products in use
- C. Systematic procedure to review published scientific journals
- D. Vigilance procedure to notify the regulatory authorities about serious incidents
Answer: A
NEW QUESTION # 24
Which of the following BEST describes the content of the "Physical, Chemical, and
Pharmaceutical Properties and Formulation" section of an IB?
- A. 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
- B. 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 - 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 description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
Answer: B
NEW QUESTION # 25
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. Clinical experience
- B. Clinical investigations
- C. Adverse event reports
- D. Literature search
Answer: B
NEW QUESTION # 26
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