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

1. A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

A) The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
B) The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
C) The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
D) The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.

2. 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

3. A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

A) Notify the regulatory authority.
B) Inform the production team.
C) Compare the approved text with the product label
D) Recommend an immediate product recall.

4. A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

A) Submit the product for review as a pharmaceutical product in Country Y.
B) Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
C) Apply for review of the additional part of the product as a pharmaceutical product in Country
D) Examine decisions made about similar products in Country Y to propose the classification of the product.

5. 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?

A) 100 patients for 12 months
B) 500 patients for three months
C) 3.000 total patient exposures
D) 200 patients for nine months

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