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Vendor: RAPS
Exam Code: RAC-GS
Exam Name: Regulatory Affairs Certification (RAC) Global Scope
Certification: RAC Regulatory Affairs Certification
Total Questions: 100 Q&A
Updated on: Dec 10, 2024
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Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
A. Before the enactment of the regulation, through the industry representative
B. Before the enactment of the regulation, through formal comments gathering process
C. After the enactment of the regulation, through the industry representative
D. After the enactment of the regulation, through a product-specific meeting
A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation.
What should be done. What action should the company take FIRST?
A. Initiate testing immediately to ensure compliance.
B. Consult with colleagues about the request.
C. Contact the regulatory authority that issued this request and discuss the requirement.
D. Send a letter back to the regulatory authority indicating why the regulation does not apply to the product.
During routine surveillance, a regulatory authority sent a company the following communication: "Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company's product. The regulatory authority is evaluating these issues to determine the need for any regulatory action." Which action would be the most appropriate FIRST step for the company to take?
A. Contact the regulatory authority to argue that its conclusions are wrong.
B. Contact the regulatory authority to discuss its findings.
C. Repeat the Hepatotoxicity tests and send the results to the regulatory authority.
D. Wait for the regulatory authority's final publication on its findings.
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The following table comprehensively analyzes the quality and value of RAC Regulatory Affairs Certification RAC-GS exam materials.