How to pass RAPS RAC-GS exam with the help of dumps?

Question # 1

According to ICH, which of the following components of study information is NOT required in a clinical study report?

A. Randomization scheme and codes 
B. Protocol and protocol amendments 
C. ListoflECsorlRBs 
D. Detailed CVofall investigators 

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Question # 2

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A. The process information and analytical result of Company X API 
B. The process information and analytical result of Company Y API 
C. The process information and the comparative analytical result of APIs from both companies
D. Information deemed appropriate by the regulatory authority

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Question # 3

Which of the following BEST describes the content of the "Physical, Chemical, and Pharmaceutical Properties and Formulation" section of an IB? 

A. A review of available data to support the determination of the chemical structure and physical attributes of the drug substance plus batch analysis and stability data for the finished formulation 
B. A detailed summary of the physical and chemical properties of the drug product with a signed expert statement addressing the suitability and stability of the formulation for its intended use
C. A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product
D. A brief summary of relevant physical, chemical, and pharmaceutical properties: instructions for storage and handling of the dosage form: and a description of the formulation

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Question # 4

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST? 

A. Site license 
B. Product license 
C. Import license 
D. Export license 

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Question # 5

What are the MOST important elements that global regulatory agencies want to know before approving a new product for sale in their countries?

A. Safety and failure risk 
B. Safety and effectiveness 
C. Quality and failure risk 
D. Quality and effectiveness 

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Question # 6

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? 

A. Discuss with the regulatory apriority and attempt to reach an acceptable solution. 
B. Inform the internal departments to redesign the product to comply with this requirement. 
C. Inform the regulatory authority that such a requirement is not applicable to the product. 
D. Notify senior management that the product cannot be registered. 

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Question # 7

Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device? 

A. Fishbone analysis 
B. Failure modes, effects, and criticality analysis 
C. Fault tree analysis  
D. Quality by design analysis 

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Question # 8

Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy? 

A. Active-controlled 
B. Cross-over 
C. Dose-ranging 
D. Placebo-controlled 

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Question # 9

During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic. What should be done in response to identifying the impurity?

A. Perform either an identification study or a non-clinical qualification study. 
B. Perform both identification and non-clinical qualification studies concurrently. 
C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study. 
D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.

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Question # 10

A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product? 

A. Plasma fractionation 
B. Product distribution 
C. Individual plasma donation 
D. Plasma pooling 

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Question # 11

The requirements for document control are located in which of the following documents?

A. ICH guidelines 
B. IEC 60601 
C. ISO 13485 
D. WHO guidelines 

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Question # 12

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 dose and volume of administration 
B. Biological activity with species and/or tissue specificity 
C. Immunochemical and functional tests 
D. Proposed product route and frequency of administration 

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Question # 13

A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A. Concept development and validation 
B. Concept development and early technical design 
C. Early technical design and product release 
D. Product release and validation 

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Question # 14

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

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Question # 15

GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following? 

A. Instructions for use 
B. Risk analysis 
C. Product literature 
D. Essential principles 

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Question # 16

Which of the following statements regarding the off-label use of drugs is CORRECT? 

A. Although the regulatory authority reviews and approves drugs for specific indications, theapproval does not limit the use of those drugs in clinical practice.
B. The regulatory authority does not restrict physician prescribing for off-label indications orregulate the manufacturer's promotion for such use.
C. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
D. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing accessto much needed drugs and devices.

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Question # 17

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

A. In vitro studies show the product to be superior. 
B. Government survey data indicate the product is superior. 
C. Results of a three-year, post-market patient survey indicate the product is superior. 
D. Results of adequate, well-controlled comparative clinical trial show the product is superior.

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Question # 18

A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product. What action should the regulatory affairs professional take FIRST?

A. No action is needed in this situation. 
B. Prepare regulatory submissions that detail the medical device's change in materials
C. Review the content of change and supporting data for the equivalency with the current material.
C. Review the content of change and supporting data for the equivalency with the current material.

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Question # 19

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?

A. For at least two years after the last approval of an application in an ICH region 
B. Fora minimum of 10 years after completion of the clinical study 
C. Three years after the last clinical study site was supplied with investigational drugs 
D. Until the product has been discontinued from marketing in all ICH regions 

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Question # 20

What is the LAST stage in the development of a quality risk management process for a medical device?

A. Risk analysis 
B. Risk reduction 
C. Risk acceptance 
D. Risk evaluation 

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