Exam (elaborations)
BCMAS 2 QUESTIONS AND ANSWERS
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BCMAS 2 QUESTIONS AND ANSWERS
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Name: Score:39 Multiple choice questions
Term 1 of 39
What is considered the most challenging step when establishing an advisory board?
Toxic effects
Selecting members
Objective and quantitative
Molecular Diagnostics
Term 2 of 39
What is an economic challenge that medical device manufacturers face?
An important guide in developing the publication plan for the product
High costs of raw materials and required personnel
-Evidence from an experiment
-Clinical practice guidelines
The cost of traveling to and from the physician's office or hospital and childcare
Term 3 of 39
TRUE/FALSE Pauses are a natural part of a conversation and should be used to make your
communication not only feel natural but also to add impact to the points you are trying to
make.
True
False
,Term 4 of 39
Which of the following are considered a high evidence priority? Check all that apply.
Center for Drug Evaluation and Research (CDER)
-Offer advice on various issues including financial or legal concerns
-To assist in the decision-making process of a business
-Help improve company products to successfully meet medical needs
-Potential discovery of adverse effects, leading to withdrawal from market
-Potential discovery of adverse effects, leading to lawsuits
-Increased potential for bias and confounding results
-Evidence from an experiment
-Clinical practice guidelines
Term 5 of 39
Which of the following are possible disadvantages of Post-Marketing Research? Select all that
apply
-Offer advice on various issues including financial or legal concerns
-To assist in the decision-making process of a business
-Help improve company products to successfully meet medical needs
-Potential discovery of adverse effects, leading to withdrawal from market
-Potential discovery of adverse effects, leading to lawsuits
-Increased potential for bias and confounding results
-The Launch SOP includes all the activities that medical affairs teams need to undertake
in preparation for the launch
-The Launch SOP planning should begin up to 24 months before the time of launch
-They must have strong knowledge in accurately interpreting and communication
scientific information
-They develop and produce print or digital documents focused on medicine and
healthcare
-They should have an interest in science, as the role is constantly evolving through
scientific advancements.
,Term 6 of 39
A company in the United States has completed work on a medical device and wants to take it
to market. The device is a cane with a handle that adjusts to different heights. Which medical
device classification should be selected when determining what FDA approval process is
needed?
Class I
Phase II
Class III
Odds Ratio
Term 7 of 39
What US law prevents manufacturers from influencing the results of the study in any way
through the monetary reward of the investigator?
The Physician Payments Sunshine Act
Communication plan
Enforcement Policy for drugs and medical devices
Federal anti-kickback statute
Term 8 of 39
What law requires companies and manufacturers to publish their interactions with HCPs?
Communication plan
-In-Vivo Testing
-In-Vitro Testing
The National Physician Payment Transparency Program
The Physician Payments Sunshine Act
, Term 9 of 39
What is an example of cost-effectiveness analysis (CEA)?
Breast implants
Osteoporosis Drug A versus Drug B on fracture risk reduction ($/fracture avoided)
An important guide in developing the publication plan for the product
High costs of raw materials and required personnel
Term 10 of 39
Which of the following is a function of an advisory board? Select all that apply
-Potential discovery of adverse effects, leading to withdrawal from market
-Potential discovery of adverse effects, leading to lawsuits
-Increased potential for bias and confounding results
-They must have strong knowledge in accurately interpreting and communication
scientific information
-They develop and produce print or digital documents focused on medicine and
healthcare
-They should have an interest in science, as the role is constantly evolving through
scientific advancements.
-Offer advice on various issues including financial or legal concerns
-To assist in the decision-making process of a business
-Help improve company products to successfully meet medical needs
-The Launch SOP includes all the activities that medical affairs teams need to undertake
in preparation for the launch
-The Launch SOP planning should begin up to 24 months before the time of launch
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