Pass RAPS RAC-GS Exam With Practice Test Questions Dumps Bundle
2021 Valid RAC-GS test answers & RAPS Exam PDF
NEW QUESTION 24
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 I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION 25
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Request documentation from the sub-contractor.
- C. Request an inspection from a regulatory authority.
- D. Ask the vendor to take responsibility.
Answer: A
NEW QUESTION 26
Which of the following criteria is MOST appropriate to define the animal species needed for the
pre-clinical toxicity testing of a biotechnology product?
- A. Proposed dose and volume of administration
- B. Biological activity with species and/or tissue specificity
- C. Proposed product route and frequency of administration
- D. Immunochemical and functional tests
Answer: B
NEW QUESTION 27
What are the MOST important elements that global regulatory agencies want to know before approving a
new product for sale in their countries?
- A. Safety and failure risk
- B. Safety and effectiveness
- C. Quality and failure risk
- D. Quality and effectiveness
Answer: B
NEW QUESTION 28
Why is it necessary to run supplemental safety pharmacology studies?
- A. To substitute the utilization of GLP
- B. To comply with regulatory authority requirements related to clinical studies
- C. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
Answer: C
NEW QUESTION 29
A company is developing a novel drug to combat AIDS. The preliminary results are very promising and
include instances of complete remission. The company has been granted patents in multiple countries for
the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential
problems for marketing of the product worldwide. Which of the following is the MOST important
consideration to discuss?
- A. The time frame in which the patent will expire
- B. International import and export regulations
- C. The stability of the drug in all zone conditions
- D. Doha Declaration in the TRIPS Agreement
Answer: C
NEW QUESTION 30
Which of the following is MOST appropriate for the purpose of lot release of biologics?
- A. Quality verification
- B. Inventory control
- C. Efficacy confirmation
- D. Safety assurance
Answer: A
NEW QUESTION 31
A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?
- A. Frequent communication
- B. Follow-up meeting after submission
- C. Documented agreement
- D. Early collaboration
Answer: A
NEW QUESTION 32
During a routine review of promotional materials for a product, a regulatory affairs professional discovers
an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory
affairs professional to take?
- A. Request that doctors stop using the product for the off-label indication.
- B. Communicate with the sales department to stop using the promotional materials.
- C. Allow doctors to use the product for the off-label indication.
- D. Contact the marketing department to recall the product.
Answer: B
NEW QUESTION 33
A regulatory affairs professional has submitted a package for regulatory review. According to the
regulation, the regulatory authority will need to respond within 90 days of submission. If there is no
response after the deadline, what is the BEST approach?
- A. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made
regarding the submission. - B. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any
outstanding questions. - C. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory
authority's response time. - D. Contact the local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission.
Answer: B
NEW QUESTION 34
Under which of the following circumstances would a regulatory authority require a more detailed
premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data
than would normally apply to an IVD device of that risk class?
- A. The device incorporates well-established technology that is already present in the market.
- B. The device is an updated version of a compliant device from the same manufacturer and contains no
substantive change. - C. Internationally recognized standards are available to cover the main aspects of the device and have
been used by the manufacturer. - D. The manufacturer's experience level with the type of IVD medical device is limited.
Answer: D
NEW QUESTION 35
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from
the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory
authorities?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
NEW QUESTION 36
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which
of the following approvals should be received FIRST?
- A. Import license
- B. Export license
- C. Site license
- D. Product license
Answer: C
NEW QUESTION 37
A global company has obtained a patent in a specific country for a newly marketed product. What would
be the BEST advice In order to protect the patent in other countries?
- A. Use the community patent system.
- B. File patents of interest in target countries.
- C. Use the Madrid system.
- D. File design patents in target countries.
Answer: B
NEW QUESTION 38
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation
based on which of the following?
- A. Risk analysis
- B. Instructions for use
- C. Product literature
- D. Essential principles
Answer: A
NEW QUESTION 39
The manufacturer of an API was changed from Company X to Company Y during the late stage of a new
drug development. Despite differences in the manufacturing processes of the companies, both APIs meet
the current specifications. Which is the MOST appropriate information to include in the final submission
documents?
- A. The process information and the comparative analytical result of APIs from both companies
- B. Information deemed appropriate by the regulatory authority
- C. The process information and analytical result of Company Y API
- D. The process information and analytical result of Company X API
Answer: A
NEW QUESTION 40
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The
intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform a non-clinical qualification study, wait until the result is available, and then consider performing
an identification study. - B. Perform an identification study, wait until the result is available, and then consider performing a
non-clinical qualification study. - C. Perform both identification and non-clinical qualification studies concurrently.
- D. Perform either an identification study or a non-clinical qualification study.
Answer: B
NEW QUESTION 41
......
Top RAPS RAC-GS Courses Online: https://www.pass4leader.com/RAPS/RAC-GS-exam.html
Free RAPS RAC-GS Exam Questions & Answer from Training Expert Pass4Leader: https://drive.google.com/open?id=1AGPbtkDmd8AZYk3VB1bvgdS8YVxdQsI_