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BCMAS Exam Questions and Correct Answer
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BCMAS Exam Questions and Correct Answer
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Elscores 8/19/2024 9:53:51 AMBCMAS Exam Questions and Correct
Answer
Most commonly used study design:
~: parallel
Under what conditions can a pharma company provide financial support for conferences and
CME?
~: 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:
~: 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:
~: advisors
, Elscores 8/19/2024 9:53:51 AM
in vitro diagnostic test - example
~: microbiology culture
in vitro versus in vivo
~: 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:
~: timely data collection
Best practice and ethical standards for reporting research published in medical journals
~: ICMJE
T/F: Elements to Assure Safe Use (ETASU) are required medical interventions taken by
HCPs prior to using the drug.
~: True
Combination product applicant(s)
~: The company that holds the application for the combination product as a whole
T/F: Severe birth defects is not an FDA mandated REMS.
~: False
, Elscores 8/19/2024 9:53:51 AM
Export challenge of a medical device company:
~: Violation of intellectual property rights
Purposes of IIS
~: develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
NOT a purpose = support pt community
Goals of pharmacogenomics
~: 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
~: 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
, Elscores 8/19/2024 9:53:51 AM
May be issued if the device existed in the market prior to 1976
EBM databases
~: DynaMed
Cochrane Library
T/F: Presentation skills are not essential for maintaining a position with MA.
~: 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?
~: If 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?
~: Document the agreement
The process of internal cooperation, coordination, and common standards across the global
pharmaceutical industry is referred to as:
~: Harmonization
5-step process to respond to a medical information question
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