2009 RAC Practice Exam Questions and Answers | Latest Version | Already Passed
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Course
2009 RAC Practice
Institution
2009 RAC Practice
2009 RAC Practice Exam Questions and
Answers | Latest Version | Already
Passed
What is the primary purpose of risk management in regulatory affairs?
A) To increase profits
B) To minimize potential risks associated with product development
C) To ensure compliance with financial regulatio...
2009 RAC Practice Exam Questions and
Answers | Latest Version | Already
Passed
What is the primary purpose of risk management in regulatory affairs?
A) To increase profits
✔✔B) To minimize potential risks associated with product development
C) To ensure compliance with financial regulations
D) To enhance marketing strategies
Which document outlines the requirements for Good Manufacturing Practices (GMP)?
A) Quality Manual
✔✔B) Code of Federal Regulations (CFR)
C) Risk Management Plan
D) Product Registration Form
What is the main objective of a clinical trial?
✔✔A) To evaluate the safety and efficacy of a product
B) To market the product effectively
1
,C) To gather competitive intelligence
D) To reduce production costs
Which organization is responsible for regulating pharmaceuticals in the United States?
A) World Health Organization (WHO)
✔✔B) Food and Drug Administration (FDA)
C) Centers for Disease Control and Prevention (CDC)
D) National Institutes of Health (NIH)
What is the primary purpose of labeling requirements in regulatory affairs?
A) To enhance product sales
✔✔B) To ensure consumer safety and informed decision-making
C) To create brand awareness
D) To comply with marketing strategies
What type of studies are often required for new drug approvals?
✔✔A) Clinical studies
B) Market research studies
2
,C) Focus group studies
D) Environmental impact studies
What does "post-market surveillance" refer to?
A) Evaluating production costs after product launch
✔✔B) Monitoring the safety and effectiveness of a product after it is on the market
C) Conducting market research after product release
D) Assessing the marketing strategy of a product
Which term refers to a drug that has not been proven safe or effective?
A) Approved drug
B) Investigational drug
✔✔C) Experimental drug
D) Generic drug
What is the role of an Institutional Review Board (IRB)?
A) To approve marketing strategies
✔✔B) To ensure ethical standards in clinical trials
3
, C) To manage production processes
D) To assess financial implications of trials
What is a common requirement for drug approval submissions?
A) Cost-benefit analysis
✔✔B) Evidence of safety and efficacy
C) Market potential assessment
D) Production timeline
Which term describes the process of evaluating and approving new medical devices?
✔✔A) Premarket approval (PMA)
B) Post-market evaluation
C) Clinical evaluation
D) Quality assurance
What is the purpose of a Quality Assurance (QA) program?
A) To enhance marketing initiatives
✔✔B) To ensure product quality and compliance with regulations
4
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