Latest RAC-US Actual Free Exam Questions Updated 100 Questions
Free RAC-US Exam Braindumps certification guide Q&A
NEW QUESTION 37
The safety database for an anti-hypertensive drug consists of the following:
* 461 patients exposed for three months
* 343 patients exposed for six months
* 112 patients exposed for nine months
* 74 patients exposed for 12 months
Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met?
- A. 200 patients for nine months
- B. 3.000 total patient exposures
- C. 100 patients for 12 months
- D. 500 patients for three months
Answer: C
NEW QUESTION 38
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?
- A. Identify countries where special requirements exist during the product development phase.
- B. Plan regulatory approval update meetings with senior management and stakeholders.
- C. Initiate a global submission process after all submission data are finalized.
- D. Utilize the STED template to complete global requirements.
Answer: A
NEW QUESTION 39
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Notify the global regulatory authorities.
- B. Send a "Dear Dr." letter to customers.
- C. Withdraw the affected product from the markets.
- D. Assess the potential safety risk.
Answer: A
NEW QUESTION 40
According to ICH, which of the following components of study information is NOT required in a clinical study report?
- A. Protocol and protocol amendments
- B. Detailed CV of all investigators
- C. List of lECs or lRBs
- D. Randomization scheme and codes
Answer: B
NEW QUESTION 41
Company X is planning to acquire the rights for a product marketed by Company Y.
As part of due diligence, what is the MOST important information the Company X regulatory affairs professional should ask senior management to request from Company Y?
- A. Marketing materials
- B. Intellectual properly
- C. Safety issues
- D. Clinical trial data
Answer: C
NEW QUESTION 42
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
- A. Inform the authority that the time is not suitable and request a new time
- B. Arrange for an inspection without all intended personnel.
- C. Insist that key personnel be available for the inspection.
- D. Negotiate with colleagues and the authority to find a better time.
Answer: D
NEW QUESTION 43
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Consumer
- B. Distributor
- C. Manufacturer
- D. Regulatory authority
Answer: C
NEW QUESTION 44
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase I clinical trials
- B. Pre-clinical studies
- C. Phase I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION 45
Which of the following situations does NOT require rapid communication to regulatory authorities?
- A. A statistically significant increase in the number of deaths in an animal dose finding study
- 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 clinically important increase in the rate of occurrence of an "expected." but serious
ADR
Answer: D
NEW QUESTION 46
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
- B. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- C. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
- D. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
Answer: D
NEW QUESTION 47
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 1
- B. Module 3
- C. Module 2
- D. Module 4
Answer: C
NEW QUESTION 48
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?
- A. The ISO Secretariat
- B. The ISO national member body
- C. The ISO technical committee in charge of the area
- D. The country's regulatory authority
Answer: B
NEW QUESTION 49
During several monitoring visits, a clinical trial monitor identifies serious and repeated noncompliance on the part of the PI. What action should the sponsor take?
- A. Inform the institution that granted a medical license to the Pi.
- B. Terminate the PI and inform the regulatory authorities.
- C. Send a letter of complaint to the Ethics Committee that approved the site.
- D. Increase the frequency of monitoring visits.
Answer: B
NEW QUESTION 50
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. Conduct a Phase III study for a new unrelated indication of the drug.
- C. Explore litigation strategy for patent infringements on the drug.
- D. Develop a generic version of the drug.
Answer: D
NEW QUESTION 51
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?
- A. Deny the auditor access to the room and retrieve only the requested records.
- B. Allow the auditor access to the room and records due to the current audit.
- C. Deny the auditor access to the room and records due to confidentiality concerns.
- D. Allow the auditor accompanied access to the room to retrieve the records.
Answer: D
NEW QUESTION 52
What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?
- A. Quality and failure risk
- B. Safety and failure risk
- C. Safety and effectiveness
- D. Quality and effectiveness
Answer: C
NEW QUESTION 53
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
- A. Systematic procedure to review experiences with the products in use
- B. Systematic procedure to review published scientific journals
- C. Vigilance procedure to ensure the full traceability of the products
- D. Vigilance procedure to notify the regulatory authorities about serious incidents
Answer: C
NEW QUESTION 54
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Safety and efficacy
- B. Volume and material
- C. Compatibility and safety
- D. Efficacy and material
Answer: C
NEW QUESTION 55
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?
- A. Certificate of Analysis for the finished product
- B. Certificate of Pharmaceutical Product
- C. Certificate of Free Sale
- D. Certificate of GMP
Answer: B
NEW QUESTION 56
Which of the following is the PRIMARY purpose of an audit report?
- A. To train sales representatives
- B. To define how to prepare new product submissions
- C. To carry out a complete review of product applications
- D. To document compliance history
Answer: D
NEW QUESTION 57
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?
- A. Literature search
- B. Clinical experience
- C. Clinical investigations
- D. Adverse event reports
Answer: C
NEW QUESTION 58
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