Get Started: RAC-GS Exam [2021] Dumps RAPS PDF Questions
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NEW QUESTION 52
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. File patents of interest in target countries.
- B. Use the community patent system.
- C. File design patents in target countries.
- D. Use the Madrid system.
Answer: A
NEW QUESTION 53
Which term does NOT describe the same concept as the others?
- A. Follow-on protein products
- B. Biosimilars
- C. Monoclonal antibody
- D. Subsequent entry biologics
Answer: C
NEW QUESTION 54
The intermediate manufacturing process was changed during development of a pharmaceutical. The
change may impact the API specification. Which functional area is responsible for the final approval of the
change?
- A. Regulatory
- B. Production
- C. Quality
- D. Analytical
Answer: C
NEW QUESTION 55
A company is developing a new product for the global market. A new international guideline will
recommend relevant studies in the pediatric population, and the guideline will be effective before the
approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this
guideline on the successful registration of the new product?
- A. The new guideline has no impact on the current registration plan since all relevant registration studies
are almost completed. - B. The company should consult with relevant regulatory authorities to determine the potential impact on
the current registration plan. - C. The company should initiate the required pediatric studies immediately to avoid costly delays to the
current registration plan. - D. The new guideline has no impact on the current registration plan, but the company must be prepared to
defend its decision.
Answer: B
NEW QUESTION 56
A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?
- A. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- B. In vitro studies show the product to be superior.
- C. Government survey data indicate the product is superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
Answer: A
NEW QUESTION 57
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. Transfer the notice of the upcoming international monograph change to QA for further processing.
- B. Prepare the international monograph change submission first and then prepare the local change when
required. - C. Analyze the impact of the international monograph change on the local pharmacopeia.
- D. Confirm that the international monograph change is not related to local pharmacopeia.
Answer: A
NEW QUESTION 58
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. 3.000 total patient exposures
- B. 100 patients for 12 months
- C. 200 patients for nine months
- D. 500 patients for three months
Answer: B
NEW QUESTION 59
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. Utilize the STED template to complete global requirements.
- B. Identify countries where special requirements exist during the product development phase.
- C. Initiate a global submission process after all submission data are finalized.
- D. Plan regulatory approval update meetings with senior management and stakeholders.
Answer: B
NEW QUESTION 60
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for
review and approval. The regulatory authority issues the company a written commitment that if the studies
are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and
safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified
criteria, the company receives a letter from the regulatory authority stating that it no longer believes that
the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- A. Request a meeting with the regulatory authority to discuss the application.
- B. Consult with the legal department to discuss the best course of action.
- C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application. - D. Review the regulatory guidelines to determine how to proceed.
Answer: A
NEW QUESTION 61
What is the LAST stage in the development of a quality risk management process for a medical device?
- A. Risk acceptance
- B. Risk evaluation
- C. Risk analysis
- D. Risk reduction
Answer: A
NEW QUESTION 62
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. Contact the marketing department to recall the product.
- B. Allow doctors to use the product for the off-label indication.
- C. Request that doctors stop using the product for the off-label indication.
- D. Communicate with the sales department to stop using the promotional materials.
Answer: D
NEW QUESTION 63
A company is developing a new medical device. During which initial stage is it MOST appropriate (or a
regulatory affairs professional to become involved?
- A. Early technical design and product release
- B. Concept development and early technical design
- C. Concept development and validation
- D. Product release and validation
Answer: B
NEW QUESTION 64
A company is developing a new line of products in an area that is new to the company. What is the BEST
approach?
- A. Obtain competitor research and provide the information to the management team.
- B. Ask the trade association representative to provide an overview of the new product area to the
marketing team. - C. Summarize regulatory documents and history and provide the information to the management team.
- D. Obtain regulatory documents and history and provide the information to R&D.
Answer: C
NEW QUESTION 65
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the
following?
- A. Late and/or incorrect deliverables
- B. Inadequate training
- C. Causes of non-conformities
- D. Adverse environmental impacts
Answer: C
NEW QUESTION 66
One month prior to the anticipated approval date for your product, the marketing application that you
submitted to a major regulatory authority has become the subject of an advisory committee meeting of
experts convened by the regulatory authority. The advisory committee members unanimously vote not to
approve your product because of a safety concern. Two days after the advisory committee meeting, the
regulatory authority requests additional information to support the safety of your product. Assuming you
have no additional data to provide, which of the following would be your MOST appropriate response to
the regulatory authority's request?
- A. "We have no additional information to provide at this time because we have already provided
everything needed to support our product's approval." - B. "Given the advisory committee's unanimous decision, we know that the product will not be approved,
and additional data will not make any difference." - C. "We disagree with the advisory committee's decision because the committee neglected the thorough
safety analysis that we provided." - D. "We have no additional information to provide at this time, but we can perform an additional analysis for
a specific safety concern, if necessary."
Answer: D
NEW QUESTION 67
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. Explore litigation strategy for patent infringements on the drug.
- B. Conduct a Phase III study for a new unrelated indication of the drug.
- C. Develop a generic version of the drug.
- D. Develop a better brand-name drug in the same class.
Answer: C
NEW QUESTION 68
A process is ultimately validated to ensure which of the following?
- A. The process consistently produces the desired results.
- B. The process consistently meets the desired Quantity standards
- C. The process meets the regulatory requirements.
- D. The process meets the quality system requirements.
Answer: A
NEW QUESTION 69
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. International import and export regulations
- B. The time frame in which the patent will expire
- C. Doha Declaration in the TRIPS Agreement
- D. The stability of the drug in all zone conditions
Answer: D
NEW QUESTION 70
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a
reimbursement agency?
- A. "Is the product better than currently available alternatives?"
- B. "Is the product an established gold standard?"
- C. "Is the product profitable for the manufacturer?"
- D. "Has the product been approved for mor&4nan 10 years?"
Answer: A
NEW QUESTION 71
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