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RAPS Practice Test Questions and Answers | Latest Version | 2024/2025 | Already Passed What is the role of clinical trials in regulatory submissions? A) To advertise the product B) To provide evidence of safety and effectiveness C) To decrease production costs D) To extend product shel...

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  • September 25, 2024
  • 44
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • raps practice test questions and answers latest

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RAPS Practice Test Questions and
Answers | Latest Version | 2024/2025 |
Already Passed

What is the role of clinical trials in regulatory submissions?

A) To advertise the product


✔✔B) To provide evidence of safety and effectiveness


C) To decrease production costs

D) To extend product shelf life




What does CE marking signify?


✔✔A) Compliance with European health and safety standards


B) Compatibility with environmental regulations

C) Certification of employee training

D) Confirmation of financial stability




Which of the following is a key component of a quality management system (QMS)?

A) Social media policy


✔✔B) Document control procedures

1

,C) Employee dress code

D) Marketing strategy




In the context of regulatory compliance, what does SOP stand for?


✔✔A) Standard Operating Procedure


B) Safety Operation Protocol

C) Systematic Operations Plan

D) Standardized Oversight Program




What is the purpose of a post-market surveillance system?

A) To create new marketing strategies

B) To reduce production costs


✔✔C) To monitor the safety and performance of a device after it is on the market


D) To increase company revenue




Which regulatory body oversees the approval of pharmaceuticals in the United States?


✔✔A) Food and Drug Administration (FDA)


B) European Medicines Agency (EMA)


2

,C) World Health Organization (WHO)

D) National Institutes of Health (NIH)




What is the significance of the "gold standard" in clinical trials?

A) It refers to the cheapest trial design


✔✔B) It represents the most rigorous standard for testing efficacy


C) It is a guideline for marketing products

D) It indicates a device’s profitability




Which of the following best describes a "risk-based" approach in regulation?

A) Focusing solely on financial outcomes


✔✔B) Evaluating products based on their potential risks to patients


C) Prioritizing marketing strategies

D) Assessing only the benefits of a device




What does "GMP" stand for in the context of manufacturing?

A) Good Marketing Practices

B) General Manufacturing Protocols


3

, ✔✔C) Good Manufacturing Practices


D) Guaranteed Manufacturing Process




What is the purpose of a Regulatory Affairs professional?

A) To handle sales transactions


✔✔B) To ensure compliance with regulations governing products


C) To manage company finances

D) To oversee marketing campaigns




Which term describes the process of obtaining regulatory approval before marketing a new drug?

A) Marketing authorization

B) Quality assurance


✔✔C) Premarket approval


D) Market entry analysis




How often must a medical device be registered with regulatory authorities?

A) Every month

B) Every five years


4

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