Exam Code: RAC-GS
Exam Name: Regulatory Affairs Certification (RAC) Global Scope
Updated: Nov 13, 2024
Q&As: 100
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Company X acquires Company Y. Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y's products be converted to Company X within three months. The regulatory affairs professional at Company X concludes that it is not feasible to meet this request within the time frame.
Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?
A. Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.
B. Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.
C. Submit as many labelingconversion applications as possible within the time frame and request an extension for the remaining ones.
D. Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities.
Which of the following BEST describes the process of post-marketing surveillance for healthcare products?
A. Systematic procedure to review published scientific journals
B. Systematic procedure to review experiences with the products in use
C. Vigilance procedure to ensure the full traceability of the products
D. Vigilance procedure to notify the regulatory authorities about serious incidents
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. Formulation
C. Property
D. Justification
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
A. Document any failure to follow regulatory compliance processes in employee performancereviews.
B. Develop documented procedures for regulatory compliance processes and train personnel.
C. Train all new employees on regulatory compliance processes and assign a mentor to them.
D. Train employees on all regulatory compliance processes using state-of-the-art systems.
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
A. Site license
B. Product license
C. Import license
D. Export license
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