RAPS RAC-GS Deluxe Study Guide with Online Test Engine
RAC-GS dumps review - Professional Quiz Study Materials
NEW QUESTION 24
A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?
- A. Inform the company's senior management and arrange an emergency meeting
- B. Obtain a copy of the proposed regulation and analyze the impact.
- C. Consult with the company's legal department regarding options.
- D. Arrange for additional testing of the product at the testing facility.
Answer: B
NEW QUESTION 25
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the
following?
- A. Adverse environmental impacts
- B. Causes of non-conformities
- C. Inadequate training
- D. Late and/or incorrect deliverables
Answer: B
NEW QUESTION 26
According to ICH, how many stability time points are normally required to establish a two-year shelf life for
a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
NEW QUESTION 27
A company's product was approved by a regulatory authority with the condition that further studies must
be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the
LEAST effective way to achieve this goal?
- A. Promote off-label use to a carefully selected patient population.
- B. Delay product launch until required studies are completed.
- C. Label the product for use in appropriate populations.
- D. Educate patients and healthcare providers on how to use the product
Answer: A
NEW QUESTION 28
Why is it necessary to run supplemental safety pharmacology studies?
- A. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
- B. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- C. To comply with regulatory authority requirements related to clinical studies
- D. To substitute the utilization of GLP
Answer: B
NEW QUESTION 29
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 30
According to ICH, which of the following components of study information is NOT required in a clinical
study report?
- A. Detailed CV of all investigators
- B. Randomization scheme and codes
- C. Protocol and protocol amendments
- D. List of lECs or lRBs
Answer: A
NEW QUESTION 31
The API used for an approved drug product conforms to international monograph specifications and local
pharmacopeia; however, the international monograph specifications of the API will be changing soon.
Which is the most appropriate action for the regulatory affairs professional to take FIRST?
- A. Analyze the impact of the international monograph change on the local pharmacopeia.
- B. Prepare the international monograph change submission first and then prepare the local change when
required. - C. Confirm that the international monograph change is not related to local pharmacopeia.
- D. Transfer the notice of the upcoming international monograph change to QA for further processing.
Answer: D
NEW QUESTION 32
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. Adverse event reports
- B. Clinical investigations
- C. Literature search
- D. Clinical experience
Answer: B
NEW QUESTION 33
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. Increase the frequency of monitoring visits.
- B. Terminate the PI and inform the regulatory authorities.
- C. Inform the institution that granted a medical license to the Pi.
- D. Send a letter of complaint to the Ethics Committee that approved the site.
Answer: B
NEW QUESTION 34
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?
- A. Training program for sales people
- B. Written procedure for product traceability
- C. Service operation procedures .
- D. Local reimbursement requirements
Answer: A
NEW QUESTION 35
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a
reimbursement agency?
- A. "Is the product profitable for the manufacturer?"
- B. "Is the product better than currently available alternatives?"
- C. "Has the product been approved for mor&4nan 10 years?"
- D. "Is the product an established gold standard?"
Answer: B
NEW QUESTION 36
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Regulatory authority
- B. Distributor
- C. Consumer
- D. Manufacturer
Answer: D
NEW QUESTION 37
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?
- A. Class B
- B. Class A
- C. Class D
- D. Class C
Answer: D
NEW QUESTION 38
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I clinical trials
- C. Phase III clinical trials
- D. Phase I and II clinical trials
Answer: C
NEW QUESTION 39
In addition to protection, what parameters MUST be considered when selecting the primary package (or a
product?
- A. Efficacy and material
- B. Compatibility and safety
- C. Safety and efficacy
- D. Volume and material
Answer: B
NEW QUESTION 40
During the review of a design dossier, the reviewer asks why the company has only carried out a
top-down risk approach. The reviewer is referring to which of the following?
- A. Failure mode and effect analysis
- B. ISO 14971 risk analysis
- C. Hazard and operability study
- D. Fault tree analysis
Answer: B
NEW QUESTION 41
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
- A. Product license
- B. Export license
- C. Import license
- D. Site license
Answer: D
NEW QUESTION 42
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. Request a permanent waiver from the new regulation.
- B. Communicate with the relevant internal departments.
- C. Contact the trade association for advice.
- D. Prepare documents for the files.
Answer: B
NEW QUESTION 43
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