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We provide RAPS RAC-US exam product in three different formats to accommodate diverse learning styles and help candidates prepare successfully for the RAC-US exam. These formats include RAC-US web-based practice test, desktop-based practice exam software, and Regulatory Affairs Certification (RAC) US (RAC-US) pdf file. Before purchasing, customers can try a free demo to assess the quality of the RAPS RAC-US practice exam material.

The RAC-US exam is recognized as a benchmark for regulatory knowledge in the healthcare industry. It is widely regarded as a valuable credential for professionals working in regulatory affairs, as it demonstrates their commitment to excellence and their ability to navigate complex regulatory environments. RAC-US Exam is also recognized by regulatory authorities around the world, making it a valuable certification for professionals seeking to advance their careers in the global healthcare industry.

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q52-Q57):

NEW QUESTION # 52
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. Use the community patent system.
B. File design patents in target countries.
C. File patents of interest in target countries.
D. Use the Madrid system.

Answer: C

NEW QUESTION # 53
Which of the following changes to a drug product is MOST likely to be implemented without prior regulatory authority approval?

A. Deleting an ingredient of the drug product
B. Strengthening a precaution to the product labeling
C. Introducing a new analytical method
D. Deleting a drug substance

Answer: B

NEW QUESTION # 54
Which of the following situations does NOT require rapid communication to regulatory authorities?

A. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR
B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
C. A major safety finding from a newly completed animal carcinogenicity study
D. A statistically significant increase in the number of deaths in an animal dose finding study

Answer: A

NEW QUESTION # 55
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. Apply for review of the additional part of the product as a pharmaceutical product in Country
B. Submit the product for review as a pharmaceutical product in Country Y.
C. Examine decisions made about similar products in Country Y to propose the classification of the product.
D. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

Answer: A

NEW QUESTION # 56
Which term does NOT describe the same concept as the others?

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

Answer: A

NEW QUESTION # 57
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