RAPS RAC-US Dumps PDF 100% Authentic & Unique Guideline


SAMPLE QUESTIONS:

Question No. 1

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A. In vitro studies show the product to be superior.
B. Government survey data indicate the product is superior.
C. Results of a three-year, post-market patient survey indicate the product is superior.
D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

Answer: D

Question: 2

A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of the SOP Is MOST important to consider?

A. Expiration date
B. Relevance to regulations
C. Revision history
D. Scope and level of detail

Answer: B

Question: 3

Which term does NOT describe the same concept as the others?

A. Biosimilars
B. Follow-on protein products
C. Monoclonal antibody
D. Subsequent entry biologics

Answer: C

Question: 4

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

Answer: A

Question: 5

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

A. Inadequate training
B. Late and/or incorrect deliverables
C. Causes of non-conformities
D. Adverse environmental impacts

Answer: C

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