According to ICH, which of the following components of study information is NOT required in a clinical study report?
A. Randomization scheme and codes
B. Protocol and protocol amendments
C. ListoflECsorlRBs
D. Detailed CVofall investigators
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
A. Fishbone analysis
B. Failure modes, effects, and criticality analysis
C. Fault tree analysis
D. Quality by design analysis
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation. However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
B. Inform the internal departments to redesign the product to comply with this requirement.
C. Inform the regulatory authority that such a requirement is not applicable to the product.
D. Notify senior management that the product cannot be registered.
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
A. Safety and failure risk
B. Safety and effectiveness
C. Quality and failure risk
D. Quality and effectiveness
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
A. Site license
B. Product license
C. Import license
D. Export license
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 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
C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
D. 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
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. The process information and analytical result of Company X API
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. Information deemed appropriate by the regulatory authority
Which of the following statements regarding the off-label use of drugs is CORRECT?
A. Although the regulatory authority reviews and approves drugs for specific indications, theapproval does not limit the use of those drugs in clinical practice.
B. The regulatory authority does not restrict physician prescribing for off-label indications orregulate the manufacturer's promotion for such use.
C. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
D. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing accessto much needed drugs and devices.
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
A. Instructions for use
B. Risk analysis
C. Product literature
D. Essential principles
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?
A. The minimum number of attendees necessary to address the issues
B. All senior management from the main office
C. As many as government attendees
D. As many as required by international standards
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