최신 RAC-US 무료덤프 - RAPS Regulatory Affairs Certification (RAC) US
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
정답: A
A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?
정답: C
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
정답: C
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?
According to ICH, how long should a sponsor retain the clinical study essential documents?
정답: B
A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?
정답: D
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?
정답: B
What is the LAST stage in the development of a quality risk management process for a medical device?
정답: A
Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?
정답: A
A company is preparing the submission package for a drug to be registered in international markets. When preparing the legal documentation, which document MUST comply with the
WHO recommendations?
WHO recommendations?
정답: B
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?
정답: D