BCMAS COMPLETE EXAM QUESTIONS
AND ANSWERS
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
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
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
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.
,When first working on a publication, what should authors do to identify their
rights, roles, and responsibilities? - ANSWER Document the agreement
The process of internal cooperation, coordination, and common standards across
the global pharmaceutical industry is referred to as: - ANSWER
Harmonization
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 woul
h h h h h h h h h h h h h h
d the company consult an advisory board? -
h h h h h h h
hANSWER To provide their opinion on the research and development of the drug
h h h h h h h h h h h h
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
Which are considered key items the FDA will contemplate when deciding on
whether REMS is needed? - ANSWER Seriousness of the disease
Seriousness of side effects
Benefit of the drug
In research which of the terms below describes a distortion caused by other
variables to both exposure and outcome? - ANSWER confounding
T/F: Medical writers should avoid addressing the public's questions to prevent
the spread of health misinformation. - ANSWER False
What are some of the ways that companies can benefit from non-mandated
Post-Marketing studies? - ANSWER Detect any cost-benefits associated with
the drugs
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.
AND ANSWERS
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
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
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
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.
,When first working on a publication, what should authors do to identify their
rights, roles, and responsibilities? - ANSWER Document the agreement
The process of internal cooperation, coordination, and common standards across
the global pharmaceutical industry is referred to as: - ANSWER
Harmonization
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 woul
h h h h h h h h h h h h h h
d the company consult an advisory board? -
h h h h h h h
hANSWER To provide their opinion on the research and development of the drug
h h h h h h h h h h h h
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
Which are considered key items the FDA will contemplate when deciding on
whether REMS is needed? - ANSWER Seriousness of the disease
Seriousness of side effects
Benefit of the drug
In research which of the terms below describes a distortion caused by other
variables to both exposure and outcome? - ANSWER confounding
T/F: Medical writers should avoid addressing the public's questions to prevent
the spread of health misinformation. - ANSWER False
What are some of the ways that companies can benefit from non-mandated
Post-Marketing studies? - ANSWER Detect any cost-benefits associated with
the drugs
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.
