Exam (elaborations)
BCMAS 3 QUESTIONS AND ANSWERS
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BCMAS 3 QUESTIONS AND ANSWERS
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Name: Score:28 Multiple choice questions
Term 1 of 28
What is the purpose of interactions between pharma companies and HCPs? Check all that
apply.
-To inform HCPs about the product benefits and risks, along with the latest medical
information
-To encourage medical research and education, and obtain consumer feedback
-potential of additional follow-ups
-responses to unanswered medical information questions
-recap of the discussion
The interaction is focused on persuading the HCP to prescribe a specific medication
Aging Population, changing lifestyle, rise in chronic disease, and globalization
Term 2 of 28
Severe birth defects is not an FDA mandated REMS.
True
False
Term 3 of 28
Who is required to submit a periodic safety update report?
The marketing authorization holders (MAHs) according to the data points outlined in the
EURD list.
Studies conducted independently by investigators who may serve as sponsors for their
own studies
once all phases of clinical trials demonstrate the drug is safe and effective
-Data containing adverse event reports
-Data on trends in the use of a drug for a disease
-Data on the frequency of certain drugs being prescribed
,Term 4 of 28
What are some of the types of prescriber data that a company may use? Check all that apply.
-Data containing adverse event reports
-Data on trends in the use of a drug for a disease
-Data on the frequency of certain drugs being prescribed
Studies conducted independently by investigators who may serve as sponsors for their
own studies
The marketing authorization holders (MAHs) according to the data points outlined in the
EURD list.
-To inform HCPs about the product benefits and risks, along with the latest medical
information
-To encourage medical research and education, and obtain consumer feedback
Term 5 of 28
TRUE/FALSE Physicians can be compensated for participating in an advisory board as long as
there are no "quid pro quo" elements.
True
False
Term 6 of 28
Your company now has sufficient evidence on safety and efficacy for a new COVID-19 vaccine,
and you are now ready to apply to launch your product on the market. Which application do
you need to file now?
FALSE
BLA (Biologics License Application)
Sales and marketing strategies
Thalidomide
, Term 7 of 28
The MSL career is said to have all but which of the following?
be easy to acquire
New drug substance
Phase III
Sales and marketing strategies
Term 8 of 28
What are the primary goals of the pharmaceutical industry?
Aging Population, changing lifestyle, rise in chronic disease, and globalization
Promotional materials can include off-label drug information
once all phases of clinical trials demonstrate the drug is safe and effective
Manufacture drugs and devices that prevent, treat, and cure diseases
Term 9 of 28
TRUE/FALSE Amber is an MSL, and she is planning a presentation for HCPs about a new blood
pressure medication. It is important for Amber to have a strong understanding of the clinical
trial data BEFORE going into this presentation.
True
False
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