RAPS Regulatory Affairs Certification (RAC) US 認定 RAC-US 試験問題:

1. 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) As many as required by international standards
C) All senior management from the main office
D) As many as government attendees

2. Company X acquires Company Y.
Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at
Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?

A) Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
B) Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
C) Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
D) Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.

3. 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 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 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
D) A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product

4. A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?

A) File design patents in target countries.
B) Use the Madrid system.
C) File patents of interest in target countries.
D) Use the community patent system.

5. A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A) Concept development and early technical design
B) Product release and validation
C) Concept development and validation
D) Early technical design and product release

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