BCMAS EXAM 2024 LATEST QUESTION BANK WITH ALL ACTUAL SOLUTIONS!!

Most commonly used study design: - ANSparallel Under what conditions can a pharma company provide financial support for conferences and CME? - ANSThe grants/contributions are separate from other company funds The company has had no control over the selection of content, faculty, or venue Not required by ADR reporting: - ANScareful selection of clinical trial participants Required: -recognition of events -safety signals are identified against a background of events -accurate reporting Individual board members are known as: - ANSadvisors in vitro diagnostic test - example - ANSmicrobiology culture in vitro versus in vivo - ANSin vitro describes something "in glass" such as a test tube or petri dish in vivo is "within a living organism" Fundamental requirement for ongoing risk evaluations of REMS: - ANStimely data collection Best practice and ethical standards for reporting research published in medical journals - ANSICMJE T/F: Elements to Assure Safe Use (ETASU) are required medical interventions taken by HCPs prior to using the drug. - ANSTrue Combination product applicant(s) - ANSThe company that holds the application for the combination product as a whole T/F: Severe birth defects is not an FDA mandated REMS. - ANSFalse Export challenge of a medical device company: - ANSViolation of intellectual property rights Purposes of IIS - ANSdevelop and support new indication enhance pt benefits/health outcomes improve available product safety and NOT a purpose = support pt community Goals of pharmacogenomics - ANSIndividualize therapies based on genetic differences Predict individual responses to a drug to decrease adverse drug reactions Improve the overall efficacy and safety of drugs NOT a goal = decrease medication adherence FDA clearance for medical devices - ANSMay be given for devices with substantial equivalence to a known predicate device Allows the device to be marketed and sold once a Pre-Market Notification has been submitted May be issued if the device existed in the market prior to 1976 EBM databases - ANSDynaMed Cochrane Library T/F: Presentation skills are not essential for maintaining a position with MA. - ANSFalse What would cause the FDA to require post-marketing studies or clinical trials at the time of approval or afterwards for a new product? - ANSIf the FDA becomes aware of new safety information from SADR reporting. When first working on a publication, what should authors do to identify their rights, roles, and responsibilities? - ANSDocument the agreement The process of internal cooperation, coordination, and common standards across the global pharmaceutical industry is referred to as: - ANSHarmonization 5-step process to respond to a medical information question - ANS1) Determine who the audience is 2) Understand what the primary question is 3) Develop an appropriate research strategy 4) Choose the best source 5) Assess the information source and answer the question T/f: SRDs are prepared only for HCPs in response to questions about product(s). - ANSFalse Who is required to submit a periodic safety update report? - ANSMarketing authorization holders (MAHs) according to the data points outlined in the EURD list. T/F: Surveys are classified as cross-sectional studies. - ANSTrue Medical Device User Fees Amendment of 2012 - ANSAllows the FDA to collect user fees for pre-market approvals to improve the overall review process T/F: An abbreviated new drug application (ANDA) is submitted to the FDA for generic drugs. - ANSTrue The risk associated with this type of drug may not be well understood. - ANSNew drug substance Amber is an MSL and receives a question from a physician about a medication indication that is not FDA approved. Which of the following is true? - ANSThis is an unsolicited request. This information is off-label. A Pharma company is looking to begin the development of a new drug. Why would the company consult an advisory board? - ANSTo provide their opinion on the research and development of the drug T/F: Under the second-tier regulations, in 21 CFR Part 56 (Institutional Review Board (IRB)) subpart B, there needs to be a minimum of 2 members in the IRB. - ANSFalse Which are considered key items the FDA will contemplate when deciding on whether REMS is needed? - ANSSeriousness of the disease Seriousness of side effects Benefit of the drug In research which of the terms below describes a distortion caused by other variables to both exposure and outcome? - ANSconfounding T/F: Medical writers should avoid addressing the public's questions to prevent the spread of health misinformation. - ANSFalse What are some of the ways that companies can benefit from non-mandated Post-Marketing studies? - ANSDetect any cost-benefits associated with the drugs Compare a drug with other currently available medications in the same class Detect other uses of the drugs Approximately how many slides should a 15 minute presentation include? - ANS7-8 Dr. Simpson, a neurologist, occasionally participates on an advisory board for Lightning Pharmaceuticals. Dr. Simpson has also just become a member of a national committee that makes recommendations for clinical guidelines and formulary decisions. Is Dr. Simpson required to disclose her relationship with Lightning Pharmaceuticals to the national committee she is a member of? - ANSYes, it would be unethical and potentially a conflict of interest if she does not disclose the relationship. Which statement is not true about promotional materials? A) Promotional materials must present an unbiased picture of the drug, including its risks and benefits B) All MSLs should offer the same promotional materials provided by the company and not "make their own" C) Promotional materials can include off-label drug information D) Promotional materials must adhere to FDA requirements and label information only - ANSC) Promotional materials can include off-label drug information T/F: The regulatory requirements for drug products include much tighter controls over the manufacturing process than for medical devices. - ANSTrue "The study of variations in DNA and RNA characteristics as related to drug response" - ANSPharmacogenomics T/F: A kick-off call is a call in which the pharma company brings in the KOL (physician, nurse practitioner, pharmacist, etc.) who will collaborate in developing the publication. - ANSTrue T/F: Misuse of funding resources is a potential disadvantage of IIS - ANSTrue What is the scientific platform? - ANSAn important guide in developing the publication plan for the product Which step of the device development process involves the product launch and post-market safety monitoring? - ANSStep 5 direct medical costs - ANSmedically-related costs used directly in providing treatment What can be both a challenge for advisory boards and a key element to a board's success? - ANSpreparing and planning for a meeting, including the use of an agenda and meeting moderator A company is developing an advisory board for a new medical device, what are two essential compliance aspects for the company to keep in mind? - ANSBoard should have clear learning objectives with meeting materials aligned. Board should fill a knowledge gap that the company has. First step of the process for device development? - ANSDevice discovery and concept Which is the chief consumer watchdog which assesses new drugs before they hit the market and continues to monitor safety after they are marketed? - ANSCenter for Drug Evaluation and Research (CDER) Which drug description would be most likely to meet approval as a generic drug? - ANSgeneric drug is available in the same approved strengths and dosage as the brand-name drug triad between manufacturers, HCPs, and consumers - ANSmodel for the biopharmaceutical industry where HCPs are the important "middlemen" When might someone utilize an RMP/REMS? - ANSbetter identify, characterize, and minimize a