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How much is the cost for taking the RAPS RAC-US Certification Exam?

The cost for the RAPS RAC-US Certification Exam is 490 USD for members and 615 USD for non-member of the RAPS. Warning! The exam fees should be paid in US dollars only.

Who can take the RAPS RAC-US Certification Exam?

The targeted audience for the RAPS RAC-US certification exam is regulatory professionals involved in the pharmaceutical and medical device industries. However, candidates from any related field can take the RAPS RAC-US exam provided that they have sufficient knowledge in the area of medical devices and pharmaceuticals regulations. Individuals having designations like Pharmacist, Regulatory Scientist, Medical Device Regulatory Specialist, etc. may also apply. The RAC-US exam dumps say that Senior managers with the ability to make recommendations for a particular company's products and services are also eligible to take the exam. Chat with us now to learn more about the eligibility requirements and other requirements for this certification exam.

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There are many ways to prepare for the RAPS RAC-US Certification Exam. The candidate must make sure that he/she prepares well for the exam. Here are some of the ways to prepare for the RAPS RAC-US Certification Exam:

Take practice exams: The candidate must practice a lot and take practice exams on a regular basis. Candidates must ensure that they take practice exams regularly and prepare for the actual exam. Racadm exams help you to get familiar with the exam format and also help in building confidence.

Understand the topics well: It is important for the candidates to learn well the concepts related to the topics of the RAC-US Certification. The candidate must learn the concept thoroughly by referring to the course outline provided by RAPS.

Read in a disciplined way: It is important for the candidate to read well and in a disciplined manner. The candidate must give time for studying each day and practice frequently to learn the concepts and techniques. Identification of the weak and strong areas will help the candidate to prepare well for the exam.

You can also consider resources like guides, paid and free courses, books about Regulatory Affairs, concerning video tutorials for the prep of the RAPS RAC-US Certification Exam. But the most appropriate source for the preparation of the RAC-US Exam is the practice exams of the PrepAwayTest. These practice exams will provide you with an idea of what to expect from the RAC-US Certification exam. The RAC-US exam dumps will help you to determine your weaknesses and strengths as well as how much time to spend on each topic in a well-organized way. The practice exams will also help the candidates to understand how to approach questions in the exam in a smart way.

RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q82-Q87):

NEW QUESTION # 82
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?

A. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."B. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."C. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."D. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."

Answer: C


NEW QUESTION # 83
The API used for an approved drug product conforms to international monograph specifications and local pharmacopeia; however, the international monograph specifications of the API will be changing soon. Which is the most appropriate action for the regulatory affairs professional to take FIRST?

A. Analyze the impact of the international monograph change on the local pharmacopeia.B. Prepare the international monograph change submission first and then prepare the local change when required.C. Confirm that the international monograph change is not related to local pharmacopeia.D. Transfer the notice of the upcoming international monograph change to QA for further processing.

Answer: D


NEW QUESTION # 84
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?

A. Proposed product route and frequency of administrationB. Immunochemical and functional testsC. Biological activity with species and/or tissue specificityD. Proposed dose and volume of administration

Answer: C


NEW QUESTION # 85
A process is ultimately validated to ensure which of the following?

A. The process meets the regulatory requirements.B. The process consistently produces the desired results.C. The process consistently meets the desired Quantity standardsD. The process meets the quality system requirements.

Answer: B


NEW QUESTION # 86
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

A. Clinical experienceB. Clinical investigationsC. Adverse event reportsD. Literature search

Answer: B


NEW QUESTION # 87
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