This page was exported from IT certification exam materials [ http://blog.dumpleader.com ] Export date:Sat Jan 18 10:19:54 2025 / +0000 GMT ___________________________________________________ Title: Get Ready to Pass the RAC-US exam with RAPS Latest Practice Exam [Q17-Q40] --------------------------------------------------- Get Ready to Pass the RAC-US exam with RAPS Latest Practice Exam Get Prepared for Your RAC-US Exam With Actual RAPS Study Guide! Where can I take RAPS RAC-US Certification Exam? The RAPS program has a partnership with Scantron. This allows candidates to choose any testing center of their choice to take the RAPS RAC-US Certification Exam. You can find the center's location with the help of the RAC-US exam dumps. Moreover, candidates can also take the RAPS RAC-US Certification Exam online at their convenience from the comfort of their home or office. Treat or forestall this opportunity and get registered for the exam.   Q17. Which of the following BEST describes the content of the “Physical, Chemical, andPharmaceutical Properties and Formulation” section of an IB?  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  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  A description and flow chart illustrating the synthetic route for the active ingredient and the preparation method of the finished product  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 Q18. Company X acquires Company Y.Both companies produce pharmaceuticals distributed globally. A regulatory authority requires that all labeling for Company Y’s products be converted to Company X within three months. The regulatory affairs professional atCompany X concludes that it is not feasible to meet this request within the time frame.Which is the FIRST step that the regulatory affairs professional at Company X should take to address the situation?  Develop a plan of action with tasks, timelines, and responsibilities and request an extension period from the regulatory authority.  Request additional resources from senior management in order to complete the labeling conversion within the time frame given by the regulatory authority.  Submit as many labeling conversion applications as possible within the time frame and request an extension for the remaining ones.  Convene an urgent meeting with internal stakeholders to inform them of the regulatory authority requirement and assign responsibilities. Q19. Why is it necessary to run supplemental safety pharmacology studies?  To substitute the utilization of GLP  To comply with regulatory authority requirements related to clinical studies  To evaluate potential adverse pharmacodynamics effects not addressed by the core battery  To provide adverse reaction reports and the results of the statistical data to the regulatory authority Q20. A process is ultimately validated to ensure which of the following?  The process meets the regulatory requirements.  The process meets the quality system requirements.  The process consistently produces the desired results.  The process consistently meets the desired Quantity standards Q21. Which of the following BEST describes the process of post-marketing surveillance for healthcare products?  Systematic procedure to review published scientific journals  Systematic procedure to review experiences with the products in use  Vigilance procedure to ensure the full traceability of the products  Vigilance procedure to notify the regulatory authorities about serious incidents Q22. 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?  Transfer the notice of the upcoming international monograph change to QA for further processing.  Prepare the international monograph change submission first and then prepare the local change when required.  Confirm that the international monograph change is not related to local pharmacopeia.  Analyze the impact of the international monograph change on the local pharmacopeia. Q23. As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?  Site license  Product license  Import license  Export license Q24. Following the introduction of a new regulation, an evaluation of the company’s products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.What should the regulatory affairs professional do FIRST to meet the new requirement?  Contact the trade association for advice.  Communicate with the relevant internal departments.  Prepare documents for the files.  Request a permanent waiver from the new regulation. Q25. Who has the PRIMARY responsibility for recall of products with quality defects?  Consumer  Distributor  Manufacturer  Regulatory authority Q26. An inspection of a manufacturing site determines that a number of manufacturing changes have been implemented without obtaining the necessary regulatory clearance. Which of the following actions should the regulatory affairs professional complete FIRST?  Stop product manufacturing.  Establish validation procedures.  Assess the impact of the changes.  Review the stability data for the changes. Q27. Which term does NOT describe the same concept as the others?  Biosimilars  Follow-on protein products  Monoclonal antibody  Subsequent entry biologics Q28. A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company’s new product.What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?  The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.  The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.  The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.  The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan. Q29. After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?  Resubmit the entire package.  Inform upper management immediately.  Contact the legal department and ask them how to proceed.  Verify the procedure in the regulation for the corrections. Q30. A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?  In vitro studies show the product to be superior.  Government survey data indicate the product is superior.  Results of a three-year, post-market patient survey indicate the product is superior.  Results of adequate, well-controlled comparative clinical trial show the product is superior. Q31. During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The productIs distributed globally.Which of the following is the most appropriate action to take FIRST?  Withdraw the affected product from the markets.  Send a “Dear Dr.” letter to customers.  Notify the global regulatory authorities.  Assess the potential safety risk. Q32. During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?  ISO 14971 risk analysis  Failure mode and effect analysis  Fault tree analysis  Hazard and operability study Q33. Which of the following situations does NOT require rapid communication to regulatory authorities?  A clinically important increase in the rate of occurrence of an “expected.” but seriousADR  A lack of efficacy with a medicinal product used in treating a life-threatening disease  A major safety finding from a newly completed animal carcinogenicity study  A statistically significant increase in the number of deaths in an animal dose finding study Q34. A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?  Documented agreement  Frequent communication  Early collaboration  Follow-up meeting after submission Q35. During routine surveillance, a regulatory authority sent a company the following communication: “Hepatotoxicity and suicidal behavior were identified as potential safety issues for the company’s product. The regulatory authority is evaluating these issues to determine the need for any regulatory action.” Which action would be the most appropriateFIRST step for the company to take?  Contact the regulatory authority to argue that its conclusions are wrong.  Contact the regulatory authority to discuss its findings.  Repeat the Hepatotoxicity tests and send the results to the regulatory authority.  Wait for the regulatory authority’s final publication on its findings. Q36. 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?  The minimum number of attendees necessary to address the issues  All senior management from the main office  As many as government attendees  As many as required by international standards Q37. A regulatory affairs professional is asked to review and update regulatory affairs SOPs.Which aspect of the SOP Is MOST important to consider?  Expiration date  Relevance to regulations  Revision history  Scope and level of detail Q38. 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?  3  5  10  15 Q39. Company X and Company Y both have products for the treatment of rare genetic diseases.Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?  Enter into an agreement with Company Y to perform due diligence.  Recruit a professional to gather confidential intelligence on Company Y.  Request the needed information from the Board of Directors of Company Y.  Perform a thorough library search to gather detailed information on Company Y. Q40. A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?  Approved indications of the drug  Determination of primary mode of action  Determination of product design deliverables  Guidance documents for the device  Loading … A quick overview of the RAPS RAC-US Certification Exam: Regulatory Affairs Certification US is simply called RAC-US Certification Exam. It is a rigorous, technical exam consisting of questions across two disciplines - Pharmaceutical and Medical Devices. The exam is administered through the RAPS website which also serves as a platform for the RAC certification program. Candidates need to pass both the RAC-Drugs exam and RAC-Devices exam in order to achieve RAC-US Certification. Clinical qualification is not required for this exam. RAC-US exam dumps will help you to get prepared for the exam, with ease.   Pass Your Next RAC-US Certification Exam Easily & Hassle Free: https://www.dumpleader.com/RAC-US_exam.html --------------------------------------------------- Images: https://blog.dumpleader.com/wp-content/plugins/watu/loading.gif https://blog.dumpleader.com/wp-content/plugins/watu/loading.gif --------------------------------------------------- --------------------------------------------------- Post date: 2022-12-17 14:22:24 Post date GMT: 2022-12-17 14:22:24 Post modified date: 2022-12-17 14:22:24 Post modified date GMT: 2022-12-17 14:22:24