Printable PDFRAPS RAC-US dumps - 100% Pass Guarantee!
Vendor: RAPS
Certifications: RAPS Certifications
Exam Name: Regulatory Affairs Certification (RAC) US
Exam Code: RAC-US
Total Questions: 100 Q&As ( View Details)
Last Updated: Mar 18, 2025
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RAC-US Q&A's Detail
| Exam Code: | RAC-US |
| Total Questions: | 100 |
| Single & Multiple Choice | 100 |
CertBus Has the Latest RAC-US Exam Dumps in Both PDF and VCE Format
- RAPS_certbus_RAC-US_by_Khalid_A_H_94.pdf
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RAC-US Online Practice Questions and Answers
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 Madrid system.
B. Use the community patent system.
C. File patents of interest in target countries.
D. File design patents in target countries.
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
B. Ask that the regulatory authority provide the actual product subject to the complaint.
C. Respond to the regulatory authority that the product subject to the complaint is most likely acounterfeit product.
D. Respond to the regulatory authority that the company will provide copies of the relevant QCrecords for batch release.
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?
A. Local reimbursement requirements
B. Service operation procedures
C. Training program for sales people
D. Written procedure for product traceability
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
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
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