BCMAS UPDATED EXAM COMPREHENSIVE QUESTIONS
AND ANSWERS SURE A+
✔✔At what point in the drug development process can a product launch occur? -
✔✔regulatory approval
✔✔What is Pharmacoeconomics? - ✔✔The description and analysis of the costs of
drug therapy to health care systems and society
✔✔T/F: A meta-analysis is a type of study design that uses statistics to summarize the
results of several studies. - ✔✔True
✔✔T/F: The Prescription Drug Marketing Act allows drug samples to be provided for
patient use. - ✔✔True
✔✔How do molecular diagnostics assist in understanding the pathogenesis of disease
at the molecular level? - ✔✔By detecting and measuring the presence of genetic
material or proteins associated with a specific health condition or disease
✔✔What are the reasons for applying for a grant? - ✔✔To encourage the development
of knowledge
To improve performance of individuals/groups
To support a project or program
NOT included: To get better equipment
✔✔informative abstracts - ✔✔most common
in-depth summary
results/conclusions/recommendations provided
word limit of 250-350 words
✔✔descriptive abstracts - ✔✔purpose/method/scope provided
100 words or less
does NOT include conclusion
✔✔In the United States, which organization established voluntary codes and standards
regarding ethical interactions between HCPs and pharmaceutical companies? -
✔✔Pharmaceutical Research and Manufacturers of America (PhRMA)
,✔✔When would an Investigational New Drug Application (IND) be submitted? - ✔✔to
begin clinical tests or transport new drugs across state lines
✔✔You are an MSL, and your company has just given a grant to an organization that
produces continuing medical education events. The event planner for the organization,
with whom you have a strong relationship with, asks your opinion on the proposed
venue, topics, and speakers that they will be applying your company's grant towards.
How should you respond? - ✔✔Explain that, per PhRMA code, it would be a conflict of
interest for you to make any of these suggestions.
✔✔Which section of a scientific manuscript should the inclusion/exclusion criteria fall
under? - ✔✔Methods
✔✔Many of the origins of the pharmaceutical industry originated in what country? -
✔✔Germany
✔✔Which of the following traits do individuals with strong EI possess? - ✔✔Do not hold
grudges
Have a robust vocabulary
Are a good judge of character
✔✔What is an example of primary level of evidence? - ✔✔original research publications
✔✔Which of the following elements is NOT necessary for the REMS of the Abbreviated
New Drug Application (ANDA)? - ✔✔communication plan
Needs to include:
-implementation system
-medication guide
-elements to assure safe use (ETASU)
✔✔Stephanie, a medical writer, is creating a descriptive abstract. Which of the following
should she be sure to do so as to not confuse it with an informative abstract? - ✔✔Keep
the abstract short, less than 100 words, similar to an outline
✔✔Jim, a Medical Information Specialist, supports other product initiatives by
developing a team plan that includes scheduling meetings with Key Opinion Leaders
(KOLs). What type of product initiative is this? - ✔✔conference planning committees
✔✔What is the last step of practicing EBM? - ✔✔Develop conclusive clinical judgment
and recommendations
, ✔✔Which study design assigns participants to two or more different treatment groups
without randomization? - ✔✔Quasi-experimental
✔✔Which of the following is true of medical writers? - ✔✔They develop and produce
print or digital documents focused on medicine and healthcare
They must have strong knowledge in accurately interpreting and communication
scientific information
They should have an interest in science, as the role is constantly evolving through
scientific advancements.
✔✔What best describes discounting? - ✔✔It is an adjustment based on forecasting of
money that will be spent or saved in future years
✔✔Which type of drug advertisement describes a disease but does not discuss a
specific medication? - ✔✔Help-seeking
✔✔Which of the following considers the extent to which the reaction can cause harm? -
✔✔Seriousness
✔✔What does health outcomes research encompass? - ✔✔Pharmacoeconomic,
therapeutic, nontherapeutic, and Quality of Life (QOL) outcomes
✔✔How does the role of pharmacovigilance work to assure the safety of drug products?
- ✔✔Identifies safety signals
Establishes a method for analyzing data to detect safety problems
Collects adverse event data
✔✔A company made a modification to a device that has FDA-established performance
standards for the device and the modification already in place. Which FDA filing type
should the company submit? - ✔✔Abbreviated 510(k)
✔✔SMART paradigm - ✔✔Specific
Measurable
Assignable
Realistic
Time-related
✔✔T/F: Audience members come to a presentation with the primary focus of, "what's in
it for me?" - ✔✔True
AND ANSWERS SURE A+
✔✔At what point in the drug development process can a product launch occur? -
✔✔regulatory approval
✔✔What is Pharmacoeconomics? - ✔✔The description and analysis of the costs of
drug therapy to health care systems and society
✔✔T/F: A meta-analysis is a type of study design that uses statistics to summarize the
results of several studies. - ✔✔True
✔✔T/F: The Prescription Drug Marketing Act allows drug samples to be provided for
patient use. - ✔✔True
✔✔How do molecular diagnostics assist in understanding the pathogenesis of disease
at the molecular level? - ✔✔By detecting and measuring the presence of genetic
material or proteins associated with a specific health condition or disease
✔✔What are the reasons for applying for a grant? - ✔✔To encourage the development
of knowledge
To improve performance of individuals/groups
To support a project or program
NOT included: To get better equipment
✔✔informative abstracts - ✔✔most common
in-depth summary
results/conclusions/recommendations provided
word limit of 250-350 words
✔✔descriptive abstracts - ✔✔purpose/method/scope provided
100 words or less
does NOT include conclusion
✔✔In the United States, which organization established voluntary codes and standards
regarding ethical interactions between HCPs and pharmaceutical companies? -
✔✔Pharmaceutical Research and Manufacturers of America (PhRMA)
,✔✔When would an Investigational New Drug Application (IND) be submitted? - ✔✔to
begin clinical tests or transport new drugs across state lines
✔✔You are an MSL, and your company has just given a grant to an organization that
produces continuing medical education events. The event planner for the organization,
with whom you have a strong relationship with, asks your opinion on the proposed
venue, topics, and speakers that they will be applying your company's grant towards.
How should you respond? - ✔✔Explain that, per PhRMA code, it would be a conflict of
interest for you to make any of these suggestions.
✔✔Which section of a scientific manuscript should the inclusion/exclusion criteria fall
under? - ✔✔Methods
✔✔Many of the origins of the pharmaceutical industry originated in what country? -
✔✔Germany
✔✔Which of the following traits do individuals with strong EI possess? - ✔✔Do not hold
grudges
Have a robust vocabulary
Are a good judge of character
✔✔What is an example of primary level of evidence? - ✔✔original research publications
✔✔Which of the following elements is NOT necessary for the REMS of the Abbreviated
New Drug Application (ANDA)? - ✔✔communication plan
Needs to include:
-implementation system
-medication guide
-elements to assure safe use (ETASU)
✔✔Stephanie, a medical writer, is creating a descriptive abstract. Which of the following
should she be sure to do so as to not confuse it with an informative abstract? - ✔✔Keep
the abstract short, less than 100 words, similar to an outline
✔✔Jim, a Medical Information Specialist, supports other product initiatives by
developing a team plan that includes scheduling meetings with Key Opinion Leaders
(KOLs). What type of product initiative is this? - ✔✔conference planning committees
✔✔What is the last step of practicing EBM? - ✔✔Develop conclusive clinical judgment
and recommendations
, ✔✔Which study design assigns participants to two or more different treatment groups
without randomization? - ✔✔Quasi-experimental
✔✔Which of the following is true of medical writers? - ✔✔They develop and produce
print or digital documents focused on medicine and healthcare
They must have strong knowledge in accurately interpreting and communication
scientific information
They should have an interest in science, as the role is constantly evolving through
scientific advancements.
✔✔What best describes discounting? - ✔✔It is an adjustment based on forecasting of
money that will be spent or saved in future years
✔✔Which type of drug advertisement describes a disease but does not discuss a
specific medication? - ✔✔Help-seeking
✔✔Which of the following considers the extent to which the reaction can cause harm? -
✔✔Seriousness
✔✔What does health outcomes research encompass? - ✔✔Pharmacoeconomic,
therapeutic, nontherapeutic, and Quality of Life (QOL) outcomes
✔✔How does the role of pharmacovigilance work to assure the safety of drug products?
- ✔✔Identifies safety signals
Establishes a method for analyzing data to detect safety problems
Collects adverse event data
✔✔A company made a modification to a device that has FDA-established performance
standards for the device and the modification already in place. Which FDA filing type
should the company submit? - ✔✔Abbreviated 510(k)
✔✔SMART paradigm - ✔✔Specific
Measurable
Assignable
Realistic
Time-related
✔✔T/F: Audience members come to a presentation with the primary focus of, "what's in
it for me?" - ✔✔True
