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There are the topics covered by the RAPS RAC-US Certification Exam:

RAC-US exam dumps cover the following topics of the RAPS RAC-US Certification Exam:

• Pharmaceutical Regulations: 40%
• Medical Device Risk Management: 10%
• Medical Devices Regulations: 25%
• Drug Safety: 25%

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Exam Dumps RAC-US Zip, RAC-US Exam Questions

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How much is the cost for taking the RAPS RAC-US Certification Exam?

The cost for the RAPS RAC-US Certification Exam is 490 USD for members and 615 USD for non-member of the RAPS. Warning! The exam fees should be paid in US dollars only.

RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q20-Q25):

NEW QUESTION # 20
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

• A. Vigilance procedure to ensure the full traceability of the products
• B. Vigilance procedure to notify the regulatory authorities about serious incidents
• C. Systematic procedure to review experiences with the products in use
• D. Systematic procedure to review published scientific journals

Answer: A
NEW QUESTION # 21
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

• A. Prepare documents for the files.
• B. Request a permanent waiver from the new regulation.
• C. Contact the trade association for advice.
• D. Communicate with the relevant internal departments.

Answer: D
NEW QUESTION # 22
Which of the following is MOST appropriate for the purpose of lot release of biologics?

• A. Efficacy confirmation
• B. Quality verification
• C. Safety assurance
• D. Inventory control

Answer: B
NEW QUESTION # 23
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

• A. Develop a better brand-name drug in the same class.
• B. Develop a generic version of the drug.
• C. Explore litigation strategy for patent infringements on the drug.
• D. Conduct a Phase III study for a new unrelated indication of the drug.

Answer: B
NEW QUESTION # 24
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

• A. Malfunction protection operated correctly
• B. Malfunction occurring before the end of service life of the medical device
• C. Adverse event caused by patient conditions
• D. Deficiency of a device found by the user prior to patient use

Answer: C
NEW QUESTION # 25
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