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COMPLETE PACKAGE::-BCMAS EXAMS WITH COMPLETE SOLUTIONS

BCMAS 1 & 2: Pharma & Medical Device Industries; Questions and Answers 100% Solved 2 Exam (elaborations) BCMAS 1, 2 & 3: Pharma, Medical Device, & IVD Industries; Questions and Answers 100% Solved 3 Exam (elaborations) BCMAS 1: Pharm Industry; Questions and Answers 100% Solved 4 Exam (elaboratio...

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BCMAS Quiz 14; Questions and Answers 100% Solved

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BCMAS Quiz 14; Questions and Answers 100% Solved An example of secondary sources of information include: Correct answer Review Articles Which of the following is an example of a primary resource? Correct answer An original phase III publication from the New England Journal of Medicine What sh...

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BCMAS 1: Pharm Industry; Questions and Answers 100% Solved

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BCMAS 1: Pharm Industry; Questions and Answers 100% Solved A medical director has completed a draft for a poster she is presenting at the next AHA meeting. She will need to work with what THREE internal functions for approval of the poster and its contents? Correct answer - clinical - legal ...

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BCMAS 1 & 2: Pharma & Medical Device Industries; Questions and Answers 100% Solved

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BCMAS 1 & 2: Pharma & Medical Device Industries; Questions and Answers 100% Solved A medical director has completed a draft for a poster she is presenting at the next AHA meeting. She will need to work with what THREE internal functions for approval of the poster and its contents? Correct ans...

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BCMAS Exam with Complete Solutions

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BCMAS Exam with Complete Solutions Which of the following is responsible for establishing guidelines for publication practices? OIG PhRMA GPP3 FDA Correct answer GPP3 ICMJE guidelines are for: Educational materials Marketing materials Manuscripts Safety reports Clinical trial protocols Co...

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BCMAS Quiz 5; Questions and Answers 100% Solved

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BCMAS Quiz 5; Questions and Answers 100% Solved Select the correct statement(s). Correct answer Cost-utility analysis (CUA): outcomes take into account patient preferences (or utilities). Cost-minimization analysis (CMA): outcomes are assumed to be equivalent ; True or False. Sarah is an HEO...

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BCMAS Exam with Complete Solutions

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BCMAS Exam with Complete Solutions Most commonly used study design: Correct answer parallel Under what conditions can a pharma company provide financial support for conferences and CME? Correct answer The grants/contributions are separate from other company funds The company has had no control ...

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BCMAS Quiz 10; Questions and Answers 100% Solved

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BCMAS Quiz 10; Questions and Answers 100% Solved Bob, a clinical development lead at Amco Pharmaceuticals, needs to determine where in the CFR he can find guidance regarding the regulations concerning the integrity of clinical trials. Where should he look? Correct answer 21 CFR Part 56 The r...

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BCMAS Chapter 1; Questions and Answers 100% Solved

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BCMAS Chapter 1; Questions and Answers 100% Solved A medical director has recently completed the final draft for a poster she is presenting at the upcoming American Heart Association (AHA) meeting. In order for the poster to be presented, she will need to work with which of the following int...

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BCMAS 1, 2 & 3: Pharma, Medical Device, & IVD Industries; Questions and Answers 100% Solved

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BCMAS 1, 2 & 3: Pharma, Medical Device, & IVD Industries; Questions and Answers 100% Solved A medical director has completed a draft for a poster she is presenting at the next AHA meeting. She will need to work with what THREE internal functions for approval of the poster and its contents? ...

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BCMAS Quiz 2; Questions and Answers 100% Solved

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BCMAS Quiz 2; Questions and Answers 100% Solved Which of the following describes a Class I medical device? Correct answer A low risk medical device As a result of the Affordable Care Act, manufacturers are charged an excise tax of ____% on every medical device sold, with a few exemptions, su...

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BCMAS Samp; Questions and Answers 100% Solved

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BCMAS Samp; Questions and Answers 100% Solved Which of the following is responsible for establishing guidelines for publication practices? OIG PhRMA GPP3 FDA Correct answer GPP3 ICMJE guidelines are for: Educational materials Marketing materials Manuscripts Safety reports Clinical trial...

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BCMAS Questions Bank; Questions and Answers 2024 Update 100% Solved

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BCMAS Questions Bank; Questions and Answers 2024 Update 100% Solved One of the important functions of an advisory board is to: Correct answer Address knowledge gaps Point-of-Care diagnostics are: Correct answer Simple medical tests that may produce immediate results True or False: Publicati...

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BCMAS 8, 9, & 10: Regulatory & Compliance; Questions and Answers 100% Solved

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BCMAS 8, 9, & 10: Regulatory & Compliance; Questions and Answers 100% Solved What are the three essentials of an effective presentation? Correct answer - know your audience - prepare - be ready to improvise In order to establish authority & credibility you need to be able to: a) not exceed ...

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BCMAS Study 3; Questions and Answers 100% Solved

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BCMAS Study 3; Questions and Answers 100% Solved 1) Jessica is a researcher conducting a pharmacoeconomic analysis for a study. What is the best description of a sensitivity analysis she must perform before presenting the results? Correct answer It allows one to determine how the results of ...

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BCMAS Study Set; Questions and Answers 100% Solved

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BCMAS Study Set; Questions and Answers 100% Solved Which section of a scientific manuscript should the inclusion/exclusion criteria fall under? Correct answer Methods Which statements are true about FDA approvals for medical devices? Select all that apply Correct answer -Requires clinical ...

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BCMAS Study Set 3; Questions and Answers 100% Solved

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BCMAS Study Set 3; Questions and Answers 100% Solved What process minimizes redundant or conflicting standards that may have evolved independently? Correct answer harmonization A company in the United States has completed work on a medical device and wants to take it to market. The device do...

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BCMAS Quiz 4; Questions and Answers 100% Solved

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BCMAS Quiz 4; Questions and Answers 100% Solved True or false: A pharmaceutical company may fund a research grant provided the research aims to support evidence of drug efficacy. Correct answer False True or false: The FDA requires companies to abide by certain regulations with regards to sp...

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BCMAS 14-17: MI, MSLs, Grants, & Boards; Questions and Answers 100% Solved

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BCMAS 14-17: MI, MSLs, Grants, & Boards; Questions and Answers 100% Solved MI provides data-driven, targeted, and fair-balanced medical information for HCPs usually during what phase? Correct answer Phase III clinical trials What requires companies to report certain payments to the federal gov...

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BCMAS Quiz 1; Questions and Answers 100% Solved

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BCMAS Quiz 1; Questions and Answers 100% Solved A scientist working at a pharmaceutical company discovers a currently commercialized Betablocker that fits well into the company's current cardiovascular product portfolio. To which team should she communicate this information? Correct answer Th...

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BCMAS Terms (Terms used throughout BCMAS) Questions and Answers 100% Solved

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BCMAS Terms (Terms used throughout BCMAS) Questions and Answers 100% Solved Abbreviated New Drug Application Correct answer Application to be submitted for FDA approval of generic drugs, where data about bioequivalence or therapeutic equivalence must be clearly demonstrated. Companies are all...

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BCMAS Exam; Questions and Answers 100% Solved

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BCMAS Exam; Questions and Answers 100% Solved A company made a modification to a device that has FDA-established performance standards for the device and the modification already in place. Which FDA filing type should the company submit? Correct answer Abbreviated 510(k) Which of the followi...

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BCMAS Study 2; Questions and Answers 100% Solved

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BCMAS Study 2; Questions and Answers 100% Solved Which of the following is defined as, "the study of variations of DNA and RNA characteristics as related to drug response"? Correct answer Pharmacogenomics What must tests involve to be considered in vitro diagnostics? Correct answer Samples o...

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