Free RAC-GS Exam Braindumps (page: 8)

According to ICH, what is the MAXIMUM amount of timein calendar days that anorganizationhas from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

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?

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?

In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?