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The registration process for the RAPS RAC-US Certification Exam:

Steps to register for the RAPS RAC-US Certification Exam are simple and easy. The procedure to apply for this exam is elaborated in the RAC-US exam dumps. Visit the RAPS website and click on the link to be registered for the RAC-US Certification exam. Complete the registration form and submit it along with a processing fee by using the online banking system or by mailing a check payable to RAPS. After completing the registration process, you have to schedule the exam, for this purpose login to the “Scantron”. After successful login to your account by putting password, then proceed to “My profile”, where you will see the scheduling options for the exam. Choose the preferred date and time of the RAPS RAC-US Certification Exam. Dates are flexible and can be changed before the exam. Once the exam is scheduled, take a printout of the exam details page.

Following is the prerequisite for the RAPS RAC-US Certification Exam:

• You must have 3 to 5 years of experience in regulatory affairs.
• You must be a member of RAPS, the Regulatory Affairs Professionals Society
• You should have a Bachelor's degree or higher

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Get to know about the main objectives of the RAPS RAC-US Certification Exam:

The main objective of the RAPS RAC-US Certification exam is to test your knowledge in the area of pharmaceutical and medical devices regulations and compliance. Candidates should be familiar with the current regulatory environment, as well as the latest developments in the regulatory landscape. Additionally, candidates should understand how a given company's products and services are regulated, and how those regulations affect the company. Gatherings of the knowledge of the topics covered in the exams can be found in the RAC-US exam dumps. Candidates should also have the ability to apply this knowledge to analyze and interpret the data found in various reports or articles and come up with a solution on how to regulate a company's products and services. Installed knowledge in each of these areas is essential to pass the RAC-US Certification exam.

RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q33-Q38):

NEW QUESTION # 33
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

• A. Draft a formal letter to customers in Country Y about this recall.
• B. Review alt distribution records and complaints reported in Country Y.
• C. Prepare the legal team in Country Y for possible litigations.
• D. Initiate a mandatory recall of the product in Country Y.

Answer: B

NEW QUESTION # 34
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

• A. All senior management from the main office
• B. The minimum number of attendees necessary to address the issues
• C. As many as government attendees
• D. As many as required by international standards

Answer: B

NEW QUESTION # 35
In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

• A. Product formulation
• B. Product registration
• C. Product requirements
• D. Product stability

Answer: D

NEW QUESTION # 36
The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

• A. Regulatory
• B. Analytical
• C. Quality
• D. Production

Answer: C

NEW QUESTION # 37
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. Literature search
• B. Adverse event reports
• C. Clinical experience
• D. Clinical investigations

Answer: D

NEW QUESTION # 38
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