[Aug 28, 2021] Latest RAC-GS Exam with Accurate Regulatory Affairs Certification (RAC) Global Scope PDF Questions
Practice To RAC-GS - PassLeaderVCE Remarkable Practice On your Regulatory Affairs Certification (RAC) Global Scope Exam
NEW QUESTION 26
Who has the PRIMARY responsibility for recall of products with quality defects?
- A. Manufacturer
- B. Distributor
- C. Consumer
- D. Regulatory authority
Answer: A
NEW QUESTION 27
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 Madrid system.
- C. File design patents in target countries.
- D. Use the community patent system.
Answer: A
NEW QUESTION 28
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the
manufacturing process. Which of the following stakeholders should be notified FIRST?
- A. Clinical affairs
- B. Quality improvement
- C. Quality assurance
- D. Regulatory agency
Answer: C
NEW QUESTION 29
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase III clinical trials
- B. Phase I and II clinical trials
- C. Phase I clinical trials
- D. Pre-clinical studies
Answer: A
NEW QUESTION 30
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 4
- B. Module 3
- C. Module 1
- D. Module 2
Answer: D
NEW QUESTION 31
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. Arrange for additional testing of the product at the testing facility.
- C. Consult with the company's legal department regarding options.
- D. Obtain a copy of the proposed regulation and analyze the impact.
Answer: D
NEW QUESTION 32
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 provide answers to any
outstanding questions. - B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made
regarding the submission. - C. Contact the local political representative and ask for intervention with the regulatory authority to obtain
a decision regarding the submission. - D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory
authority's response time.
Answer: A
NEW QUESTION 33
A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?
- A. In vitro studies show the product to be superior.
- B. Government survey data indicate the product is superior.
- C. Results of adequate, well-controlled comparative clinical trial show the product is superior.
- D. Results of a three-year, post-market patient survey indicate the product is superior.
Answer: C
NEW QUESTION 34
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. Educate patients and healthcare providers on how to use the product
- B. Delay product launch until required studies are completed.
- C. Promote off-label use to a carefully selected patient population.
- D. Label the product for use in appropriate populations.
Answer: C
NEW QUESTION 35
A regulatory affairs professional is asked to review and update regulatory affairs SOPs. Which aspect of
the SOP Is MOST important to consider?
- A. Revision history
- B. Scope and level of detail
- C. Relevance to regulations
- D. Expiration date
Answer: C
NEW QUESTION 36
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is
the MOST important for the distributor?
- A. Service operation procedures .
- B. Local reimbursement requirements
- C. Written procedure for product traceability
- D. Training program for sales people
Answer: D
NEW QUESTION 37
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. Quality
- C. Analytical
- D. Production
Answer: B
NEW QUESTION 38
Which of the following statements regarding export regulations for an approved product is CORRECT?
- A. The product must not be labeled on the outside of the shipping package that it is intended for export.
- B. The product must not be sold or offered for sale in domestic commerce.
- C. The product must not be in accord with the specifications of the foreign purchaser.
- D. The product must not be in conflict with the laws of the country to which it is intended for export.
Answer: D
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. Assess the potential safety risk.
- B. Send a "Dear Dr." letter to customers.
- C. Withdraw the affected product from the markets.
- D. Notify the global regulatory authorities.
Answer: D
NEW QUESTION 40
A drug product presents degradation during the manufacturing process. In addition to the amount, what
information should be provided FIRST in order to use API overage?
- A. Specification
- B. Justification
- C. Formulation
- D. Property
Answer: B
NEW QUESTION 41
A clinical study of a drug is completed to support a marketing approval application. According to ICH, how
long should a sponsor retain the clinical study essential documents?
- A. Until the product has been discontinued from marketing in all ICH regions
- B. Three years after the last clinical study site was supplied with investigational drugs
- C. For a minimum of 10 years after completion of the clinical study
- D. For at least two years after the last approval of an application in an ICH region
Answer: D
NEW QUESTION 42
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 company should initiate the required pediatric studies immediately to avoid costly delays to the
current registration plan. - B. The company should consult with relevant regulatory authorities to determine the potential impact on
the current registration plan. - C. The new guideline has no impact on the current registration plan since all relevant registration studies
are almost completed. - 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 43
Why is it necessary to run supplemental safety pharmacology studies?
- A. To evaluate potential adverse pharmacodynamics effects not addressed by the core battery
- B. To comply with regulatory authority requirements related to clinical studies
- C. To substitute the utilization of GLP
- D. To provide adverse reaction reports and the results of the statistical data to the regulatory authority
Answer: A
NEW QUESTION 44
As a member of the product launch review committee, a regulatory affairs professional discovers a major
issue with the labeling of a product prior to production. In addition to informing the committee, which is the
BEST approach to address the issue?
- A. Correct the label text.
- B. Inform the regulatory authorities.
- C. Abort the product launch.
- D. Delay the start of product production.
Answer: B
NEW QUESTION 45
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 national member body
- B. The ISO Secretariat
- C. The country's regulatory authority
- D. The ISO technical committee in charge of the area
Answer: A
NEW QUESTION 46
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical
device?
- A. Risk estimation
- B. Risk management
- C. Risk control
- D. Risk analysis
Answer: D
NEW QUESTION 47
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug
produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly
different color and break easily.
Which of the following actions should the regulatory affairs professional take?
- A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected
product. - B. Respond to the regulatory authority that the company will provide copies of the relevant QC records for
batch release. - C. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit
product. - D. Ask that the regulatory authority provide the actual product subject to the complaint.
Answer: A
NEW QUESTION 48
During face-to-face meetings with the regulatory authority to address submission issues, what is the
BEST choice for the number of company representatives who should attend?
- A. As many as required by international standards
- B. The minimum number of attendees necessary to address the issues
- C. All senior management from the main office
- D. As many as government attendees
Answer: B
NEW QUESTION 49
......
Exam Questions and Answers for RAC-GS Study Guide Questions and Answers!: https://www.passleadervce.com/RAC-Regulatory-Affairs-Certification/reliable-RAC-GS-exam-learning-guide.html
Practice To RAC-GS - PassLeaderVCE Remarkable Practice On your Regulatory Affairs Certification (RAC) Global Scope Exam: https://drive.google.com/open?id=15LGHCLgYWacHidRBRfc4KBQ_pq9fQQQA