BCMAS Exam| 283 Questions and Answers 100% Correct
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Course
BCMAS
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BCMAS
BCMAS Exam| 283 Questions and Answers 100% CorrectBCMAS Exam| 283 Questions and Answers 100% CorrectBCMAS Exam| 283 Questions and Answers 100% CorrectBCMAS Exam| 283 Questions and Answers 100% Correct
Most commonly used study design: - ANSWER-parallel
Under what conditions can a pharma company ...
BCMAS Exam| 283 Questions and Answers 100% Correct
Most commonly used study design: - ANSWER-parallel
Under what conditions can a pharma company provide financial support for conferences
and CME? - ANSWER-The 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: - ANSWER-careful 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: - ANSWER-advisors
in vitro diagnostic test - example - ANSWER-microbiology culture
When first working on a publication, what should authors do to identify their rights, roles,
and responsibilities? - ANSWER-Document the agreement
in vitro versus in vivo - ANSWER-in 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: - ANSWER-timely data
collection
T/F: Medical writers should avoid addressing the public's questions to prevent the spread of health misinformation. - ANSWER-False
What would cause the FDA to require post-marketing studies or clinical trials at the time
of approval or afterwards for a new product? - ANSWER-If the FDA becomes aware of new safety information from SADR reporting.
The process of internal cooperation, coordination, and common standards across the global pharmaceutical industry is referred to as: - ANSWER-Harmonization Best practice and ethical standards for reporting research published in medical journals - ANSWER-ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required medical interventions taken by
HCPs prior to using the drug. - ANSWER-True
Combination product applicant(s) - ANSWER-The company that holds the application for the combination product as a whole
T/F: Severe birth defects is not an FDA mandated REMS. - ANSWER-False
Export challenge of a medical device company: - ANSWER-Violation of intellectual property rights
Purposes of IIS - ANSWER-develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and NOT a purpose = support pt community
Goals of pharmacogenomics - ANSWER-Individualize 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 - ANSWER-May 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 - ANSWER-DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a position with MA. - ANSWER-
False
5-step process to respond to a medical information question - ANSWER-1) 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). - ANSWER-False
Who is required to submit a periodic safety update report? - ANSWER-Marketing authorization holders (MAHs) according to the data points outlined in the EURD list.
T/F: Surveys are classified as cross-sectional studies. - ANSWER-True
Medical Device User Fees Amendment of 2012 - ANSWER-Allows 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. - ANSWER-True
The risk associated with this type of drug may not be well understood. - ANSWER-New 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? - ANSWER-This 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? - ANSWER-To 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. - ANSWER-
False
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? - ANSWER-
7-8
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? - ANSWER-Yes, it would be unethical and potentially a conflict of interest if she does not disclose the relationship.
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