RAC (Drugs) Practice Test PDF

14/03/2024, 17:03 View and Edit Coaching Report Assessment Name RAC (Drugs) Practice Test Status Expired User ID 10916440 Percentage Score 2% Date/Time Started Mar 06 2024 07:10:25 Assessment Outcome Fail Date/Time Finished Mar 06 2024 08:12:42 Questions Topic Email RAC Practice Test Results Question wording You will receive your full practice test results after the completion of this test. If you would like a copy of your results delivered via email, please enter your email address below. Please verify your email address is correct before proceeding. Choices Unscored, Scored Answer given [email protected] Correct answer N/A Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Part way through an early-stage exploratory IND for an oncology drug trial, the Sponsor requests your regulatory advice on amending the existing Protocol to include a new subset of disease and to add a new Investigator. What scenario below BEST captures the advice you should give? Choices 0 The sponsor should notify FDA within 30 days tha, 1 The sponsor should notify FDA of the new investi, 2 No reporting to FDA or IRB is required as the am, 3 The sponsor should notify FDA of the new investi Answer given Correct answer No reporting to FDA or IRB is required as the amendments to the Protocol are both considered insignificant to safety in an early-stage trial. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is TRUE regarding expedited programs for regenerative medicine therapy products? Choices 0 Information that supports more than one expedite, 1 CBER grants Fast Track Designation only on the b, 2 For Breakthrough Therapy Designation, preclinica, 3 Advantages of the RMAT Designation include all o Answer given Correct answer Advantages of the RMAT Designation include all of the benefits of Fast Track Designation and Breakthrough Therapy Designation. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 1/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following statements about biosimilars is NOT correct? Choices 0 Biosimilars cannot not be substituted for innova, 1 Biosimilars are considered to be similar to gene, 2 Biological medicine developed to be similar to a, 3 In some countriesregions, biosimilars may be app Answer given Biosimilars are considered to be similar to generic pharmaceuticals and follow the same market review and approval process as generics. Correct answer Biosimilars are considered to be similar to generic pharmaceuticals and follow the same market review and approval process as generics. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is not an investigator's responsibility? Choices 0 Submitting unanticipated adverse event reports t, 1 Submitting notices to the IRB of deviations from, 2 Maintaining records of receipt, use and disposit, 3 Reporting to the sponsor withdrawal of IRB appro Answer given Correct answer Submitting unanticipated adverse event reports to FDA Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Both GMP and GLP guidelines require which of the following? Choices 0 Batchproduction and control records, 1 Calibrationand preventive maintenance of equip, 2 First-in,first-out use of raw materials, 3 Processvalidation Answer given Correct answer Calibration and preventive maintenance of equipment Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Investigational combination products that include a device constituent part are subject to which provision of 21 CFR part 820? Choices 0 Management responsibility (21 CFR 820.20) and Pu, 1 Design Controls (21 CFR 820.30) unless the devic, 2 Corrective and preventive action (21 CFR 820.100, 3 All of the above. Answer given Correct answer Design Controls (21 CFR 820.30) unless the device constituent part is exempt from design controls. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording In the EU, which type of documentation should NOT be included in Module 1 of a submitted dossier? Choices 0 SmPC, Labeling and Package Leaflet, 1 Environmental Risk Assessment, 2 Quality Overall Summary, 3 Risk Management Plan Answer given Correct answer Quality Overall Summary https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 2/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording A sponsor is planning to initiate a pivotal clinical study for a drug-lead combination product (e.g. prefilled syringe, autoinjector, etc.). For the device constituent of the combination product, what’s the FDA minimum regulatory requirement that must be met prior to introducing the combination product into the clinical study? Choices 0 Meet combination product cGMP requirements accor, 1 Meet the usabilityhuman factors requirement., 2 Meet the design controls requirement according t, 3 Meet the EU MDR General Safety and Performance R Answer given Correct answer Meet the design controls requirement according to 21 CFR Part 820.30, unless the device constituent is exempt from design controls requirements. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is not the sponsor’s responsibility? Choices 0 Designate appropriately qualified medical person, 1 Maintaining records of receipt, use and disposit, 2 Submitting unanticipated adverse event reports t, 3 Update the Investigators Brochure as significant Answer given Correct answer Maintaining records of receipt, use and disposition of investigational product. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Within how many days after receipt MUST the FDA file, or refuse to file, an NDA? Choices 0 30, 1 45, 2 60, 3 90 Answer given Correct answer 60 Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following would FDA consider to be obstructing an inspection? Choices 0 Scheduling an inspection at a date later than re, 1 A facility does not provide an FDA investigator , 2 The facility fails to produce requested records , 3 A facility does not allow the investigator to en Answer given Correct answer The facility fails to produce requested records in a timely manner, without a reasonable explanation. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording To improve processing for a drug product marketed under an ANDA, Formulation Development is recommending a change from microcrystalline cellulose to a coprocessed microcrystalline cellulose-starch ingredient. What level of filing documentation would likely be required for this change? Choices 0 Annual report, 1 CBE supplement, 2 CBE-30 supplement, 3 Prior approval supplement Answer given Correct answer Prior approval supplement https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 3/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following is false regarding meeting minutes for formal meetings relating to biological products regulated by CBER? Choices 0 The FDA will issue official meeting minutes to t, 1 The FDA meeting minutes are not intended to repr, 2 If it is necessary to revise the original FDA me, 3 For input on additional issues not addressed at Answer given Correct answer For input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording A company has submitted its NDA for review. When must additional safety information be submitted to FDA in a safety update report to avoid triggering an extension of the review clock? Choices 0 Sixmonths after the initial NDA submission (18, 1 Fourmonths after the initial NDA submission (1, 2 Uponinitial NDA submission, 3 AfterNDA approval Answer given Correct answer Four months after the initial NDA submission (120 day safety update) Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording On Monday, commercial stability batch testing for an approved drug produced out-of-specification results. No assignable cause had been identified as of Wednesday. What is the best action for the regulatory professional to take? Choices 0 Issuea Field Alert, 1 Initiateretesting, 2 Initiateresampling, 3 Issuean Investigative Protocol Answer given Correct answer Issue a Field Alert Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following changes can be submitted without an updated batch record for a modified-release product? Choices 0 Componentchange: deletion of colorflavor, 1 Equipmentchange: alternate equipmentsame desig, 2 Processchange: adjustment of equipment beyond , 3 Sitechange: same contiguous campus Answer given Correct answer Component change: deletion of color/flavor Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A detailed summary of product quality (CTD Module 2.3 Quality Overall Summary) and a declaration statement (CTD Module 1.4.1 Quality) are required as part of a Marketing Authorisation Application in the EU. Who has responsibility for signing this declaration statement? Choices 0 QualifiedPerson responsible for pharmacovigila, 1 Scientistsresponsible for generating the raw d, 2 Headof the Marketing Department, 3 Expertwith the necessary technical or professi Answer given Correct answer Expert with the necessary technical or professional qualifications https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 4/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording Your company is planning to place a generic, non-biologic product on the market. The original product manufacturer’s data exclusivity period is over. As a regulatory professional, how will you advise your company to obtain a faster Marketing Authorisation? Choices 0 Atthe outset, to commission a top rated clinic, 1 Toconduct bioavailability and bioequivalence s, 2 Nofresh documentation is required for a Market, 3 Toconduct all the studies and generate the req Answer given Correct answer To conduct bioavailability and bioequivalence studies to prove equivalence to the original product and refer to the original product manufacturer’s file for the rest of the documentation Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording During what period of the MRP should an individual within the applicant company always be available to resolve any issues that may arise? Choices 0 Five-dayperiod immediately following the close, 1 Ten-dayperiod for the preparation of the respo, 2 Ninety-dayperiod for the reference member stat, 3 Ninety-dayperiod for approval by the concerned Answer given Correct answer Ninety-day period for approval by the concerned member states Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A manufacturer wants to gain approval of an over-the-counter (OTC) product already approved in a Reference Member State by a competitor for a different indication. Which of the following filings are required? Choices 0 File a Type II Variation, 1 File a Type I Variation, 2 No additional filings are required, as this is a, 3 File a new Marketing Authorisation Application Answer given Correct answer File a new Marketing Authorisation Application Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A biotechnology company is developing a follow-on biologic it claims is similar to an authorised biologic medicinal product and already available on the market. What should the regulatory professional submit with the Marketing Authorisation Application dossier? Choices 0 Abridgedquality dossier including only compara, 1 Fullquality dossier, 2 Fullquality dossier supplemented by the demons, 3 Noneed to include a quality dossier Answer given Correct answer Full quality dossier supplemented by the demonstration of comparability https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 5/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording How many days after the start of the DCP Assessment Step I does the reference member state have to supply the draft labeling to the concerned member states and applicant? Choices 0 30, 1 70, 2 90, 3 120 Answer given Correct answer 120 Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A regulatory professional is requested to assist on a submission strategy for a non-innovative drug authorized in one member state. What is the BEST strategy for the extension of the license in other member states? Choices 0 Usethe Centralized Procedure, 1 Usethe MRP, 2 Requesta CPP, 3 Applyto each member state in turn Answer given Correct answer Use the MRP Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A manufacturer is sponsoring a pharmaceutical clinical trial. Before starting the trial, the clinical investigator MUST first obtain which of the following? Choices 0 Publicationcopyright statements, 1 Approvalfrom the ethics committee, 2 Signedinformed consent forms, 3 AppropriateICH forms Answer given Correct answer Approval from the ethics committee Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A clinical investigator would like to use an investigational medicinal product to treat a gravely ill patient who does not meet the protocol inclusion criteria. However, in the expert opinion of the clinical investigator, the product would be the best option for that patient. What action is MOST appropriate for the clinical investigator to take? Choices 0 Askthe trial sponsor to obtain CA approval for, 1 Notifythe trial sponsor of the deviation to th, 2 Obtainapproval from the CA for compassionate u, 3 Treatthis particular patient with the product, Answer given Correct answer Obtain approval from the CA for compassionate use of the product for this particular patient Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording What is the least likely action OPDP will take in response to this promotional communication? Choices 0 OPDP will consider whether the promotional mater, 1 OPDP will consider the REMS and boxed warnings i, 2 OPDP will consider whether the promotional claim, 3 OPDP will take no action as their role is purely Answer given Correct answer OPDP will take no action as their role is purely advisory on promotional materials, especially on FDA-approved products. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 6/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording Your company is planning to have a new drug product to be registered with local health authority and you have been tasked to prepare for pre-submission meeting. What are your courses of actions in sequence? Choices 0 Book a meeting with health authority., 1 Compile the documents required for meeting with , 2 Check with internal stakeholders on the readines, 3 Check on the list of attendees for the meeting. Answer given Correct answer Check on the list of attendees for the meeting. Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording When advertising, which type of information can be provided without limitations relative to medicinal products? Choices 0 Publicadvertising of reimbursable over-the-cou, 1 Direct-toconsumeradvertising of prescription , 2 Diseaseinformation with no reference to a medi, 3 Comparativeadvertising Answer given Correct answer Disease information with no reference to a medicinal product Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording As per EMA Variation Guideline, when the national competent authorities or the European Medicines Agency needs to be notified of the change (submitted) immediately upon implementation, the type of variation is: Choices 0 Type 1A, 1 Type 1Ain, 2 Type 1B, 3 Type II Answer given Correct answer Type 1Ain Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording A variation for a complex manufacturing change should include which of the following? Choices 0 Astatement and CV from an independent pharmace, 1 Anexpert statement and CV from a quality exper, 2 Anexpert statement and CV from a clinical expe, 3 Anexpert statement from the site quality head Answer given Correct answer An expert statement and CV from a quality expert Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording After several years of successful marketing of a medicinal product for human use, a company wants to authorize a new therapeutic indication for the product. What is the MOST appropriate regulatory submission route? Choices 0 TypeIA variation, 1 TypeIB variation, 2 TypeII variation, 3 Extensionapplication Answer given Correct answer Type II variation https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 7/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording A manufacturer submits a Type IA variation application for a product authorised through the Mutual Recognition Procedure. Which of the following courses of action could happen? Choices 0 Within30 days, the Reference Member State ackn, 1 Within30 days, the Reference Member State appr, 2 Within14 days, the European Medicines Agency (, 3 Within30 days, EMA approves the variation Answer given Correct answer Within 30 days, the Reference Member State acknowledges it accepts or rejects the variation IA Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following is MOST appropriate for the purpose of lot release of biologics? Choices 0 Inventorycontrol, 1 Safetyassurance, 2 Efficacyconfirmation, 3 Qualityverification Answer given Correct answer Quality verification Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following agencies initiated a pilot program “PARALLEL SCIENTIFIC ADVICE (HUMAN MEDICINAL PRODUCTS)” to exchange their views on scientific issues during the development phase of new medicinal products? Choices 0 PMDA (Pharmaceuticals and Medical Devices Agency, 1 EMA (European Medicine Agency), EU and MHRA (Med, 2 USFDA (United States Food and Drug Administratio, 3 All ICH (International Council for Harmonization Answer given Correct answer USFDA (United States Food and Drug Administration) and EMA (European Medicine Agency) Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording A company is developing a new chemical entity. As part of the preclinical investigations, which of the following battery of toxicity tests cannot be waived and MUST be completed? Choices 0 Genotoxicity, 1 Carcinogenicity, 2 Localtolerance, 3 Reproductivetoxicity Answer given Correct answer Genotoxicity Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording If you run clinical trials from a site at a medical center based in Maryland, USA what investigational drugs may be shipped and to what locations? Choices 0 Investigational drugs with an Investigational Ne, 1 Investigational drugs without an IND (non-IND) c, 2 Investigational drugs (with or without an IND) c, 3 All of the above Answer given Correct answer All of the above https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 8/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs? Choices 0 Formalmortality and morbidity outcomes, 1 Highsystolic and diastolic blood pressures, 2 Organdamage secondary to hypertension, 3 Strokeand cardiovascular events Answer given Correct answer High systolic and diastolic blood pressures Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording A company is publishing an application to initiate the first clinical trial involving a new investigational drug and discovers that some stability results are not available. Which of the following individuals should the publisher contact FIRST to inquire about the missing data? Choices 0 Clinicalaffairs managerdirector, 1 Regulatoryaffairs managerdirector, 2 QCmanagerdirector, 3 QAmanagerdirector Answer given Correct answer Regulatory affairs manager/director Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording 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? Choices 0 Giventhe advisory committees unanimous decisio, 1 Wehave no additional information to provide at, 2 Wedisagree with the advisory committees decisi, 3 Wehave no additional information to provide at Answer given Correct answer "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary." Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which term does NOT describe the same concept as the others? Choices 0 Biosimilars, 1 Follow-onprotein products, 2 Monoclonalantibody, 3 Subsequententry biologics Answer given Correct answer Monoclonal antibody https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bcb… 9/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording What is the MINIMUM time in months of continuous use that mandates carcinogenicity testing for pharmaceuticals? Choices 0 2, 1 4, 2 6, 3 12 Answer given Correct answer 6 Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording A request was received from a regulatory authority asking the company to conduct product testing in compliance with a newly issued regulation. What should be done. What action should the company take FIRST? Choices 0 Initiatetesting immediately to ensure complian, 1 Consultwith colleagues about the request, 2 Contactthe regulatory authority that issued th, 3 Senda letter back to the regulatory authority Answer given Correct answer Contact the regulatory authority that issued this request and discuss the requirement Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording What statements would NOT be correct about an Authorized Generic Drug? Choices 0 It is a copy of a brand-name drug that is develo, 1 It is the same as the brand name drug in active , 2 It is the same as the brand-name drug but does n, 3 It is not listed in the Orange Book. Answer given Correct answer It is the same as the brand name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Your company has received a Warning Letter from the FDA that your marketed drug product has been found to contain ingredients, which make it adulterated, and it has been linked to hundreds of reports of minor AEs. At the same time a related product has been reported in the press as involving a legal claim by a group of children whose mothers took the medication during pregnancy many years ago. You have successfully marketed this drug for over 20 years without incident. As a regulatory specialist what is your top priority to minimize your company’s legal liability? Choices 0 Gather all pertinent information for a risk-asse, 1 Respond to the FDA WL immediately., 2 Gather all pertinent information and use your 25, 3 Respond without delay to the press reports denyi Answer given Correct answer Gather all pertinent information for a risk-assessment and recommend to the Senior Leadership Team that preliminary legal advice is obtained without delay. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bc… 10/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording In its Guidance, Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, issued in November 2017 and updated in July 2020, FDA announced a compliance and enforcement discretion policy to give manufacturers time to determine if they need to submit an IND or marketing application. This policy ended in May 2021. Choices 0 FDA will no longer exercise enforcement discreti, 1 FDA will comment, if requested, on its complianc, 2 All establishments that manufacture HCTPs regula, 3 The unapproved product may not be administered a Answer given Correct answer FDA will comment, if requested, on its compliance or enforcement approach in light of this policy change. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following claims would classify an apple as a drug? Choices 0 Itwill make you look younger., 1 Itwill satisfy hunger., 2 Itwill whiten teeth., 3 Itwill prevent colds. Answer given Correct answer "It will prevent colds." Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following would FDA consider to be obstructing an inspection? Choices 0 Scheduling an inspection at a date later than re, 1 A facility does not provide an FDA investigator , 2 The facility fails to produce requested records , 3 A facility does not allow the investigator to en Answer given Correct answer The facility fails to produce requested records in a timely manner, without a reasonable explanation. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording A specification deviation occurred on seven batches of a pharmaceutical product that could lead to a product recall. In which of the following activities is the regulatory professional MOST closely involved? Choices 0 Developinga recall strategy, 1 Establishingthe causes of the deviation, 2 Sendinga recall letter to the communication ch, 3 Writingnew SOP related to product specificatio Answer given Correct answer Developing a recall strategy Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording The sales department consults the regulatory professional regarding plans to use the same sales materials in all countries. Which indication would be acceptable to present in the sales materials? Choices 0 Indication1, 1 Indication2, 2 Indication3, 3 Noindications Answer given Correct answer No indications https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bc… 11/12 14/03/2024, 17:03 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following terms is defined as reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously? Choices 0 Index, 1 Sign, 2 Signal, 3 Symptom Answer given Correct answer Signal Topics Topic description EU Based Questions: Domain I and II Topic Detail Score % 0% EU Based Questions: Domain III and IV Topic Detail Score % 0% Global Based Questions: Domain I and II Topic Detail Score % 0% Global Based Questions: Domain III and IV Topic Detail Score % 0% US Based Questions: Domain I and II Topic Detail Score % 11% US Based Questions: Domain III and IV Topic Detail Score % 0% https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=232391960&TemplateID=2&da=1&digest=a4148a7580a0bc… 12/12

RAC (Drugs) Practice Test PDF

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