BCMAS Exam
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1. Most commonly used study design: parallel
2. Under what conditions can a pharma compa- The grants/contributions are separate
ny provide financial support for conferences from other company funds
and CME?
The company has had no control over
the selection of content, faculty, or
venue
3. Not required by ADR reporting: careful selection of clinical trial partici-
pants
Required:
-recognition of events
-safety signals are identified against a
background of events
-accurate reporting
4. Individual board members are known as: advisors
5. in vitro diagnostic test - example microbiology culture
6. 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"
7. Fundamental requirement for ongoing risk timely data collection
evaluations of REMS:
8. Best practice and ethical standards for re- ICMJE
porting research published in medical jour-
nals
, BCMAS Exam
Study online at https://quizlet.com/_bj1aoj
9. T/F: Elements to Assure Safe Use (ETASU) True
are required medical interventions taken by
HCPs prior to using the drug.
10. Combination product applicant(s) The company that holds the application
for the combination product as a whole
11. T/F: Severe birth defects is not an FDA man- False
dated REMS.
12. Export challenge of a medical device compa- Violation of intellectual property rights
ny:
13. Purposes of IIS develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
NOT a purpose = support pt community
14. Goals of pharmacogenomics Individualize therapies based on genet-
ic 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 ad-
herence
15. FDA clearance for medical devices May be given for devices with substan-
tial equivalence to a known predicate
device
Allows the device to be marketed and
, BCMAS Exam
Study online at https://quizlet.com/_bj1aoj
sold once a Pre-Market Notification has
been submitted
May be issued if the device existed in
the market prior to 1976
16. EBM databases DynaMed
Cochrane Library
17. T/F: Presentation skills are not essential for False
maintaining a position with MA.
18. What would cause the FDA to require If the FDA becomes aware of new safety
post-marketing studies or clinical trials at the information from SADR reporting.
time of approval or afterwards for a new
product?
19. When first working on a publication, what Document the agreement
should authors do to identify their rights,
roles, and responsibilities?
20. The process of internal cooperation, coordi- Harmonization
nation, and common standards across the
global pharmaceutical industry is referred to
as:
21. 5-step process to respond to a medical infor- 1) Determine who the audience is
mation question 2) Understand what the primary ques-
tion is
3) Develop an appropriate research
strategy
4) Choose the best source
, BCMAS Exam
Study online at https://quizlet.com/_bj1aoj
5) Assess the information source and
answer the question
22. T/f: SRDs are prepared only for HCPs in re- False
sponse to questions about product(s).
23. Who is required to submit a periodic safety Marketing authorization holders
update report? (MAHs) according to the data points
outlined in the EURD list.
24. T/F: Surveys are classified as cross-sectional True
studies.
25. Medical Device User Fees Amendment of Allows the FDA to collect user fees for
2012 pre-market approvals to improve the
overall review process
26. T/F: An abbreviated new drug application True
(ANDA) is submitted to the FDA for generic
drugs.
27. The risk associated with this type of drug may New drug substance
not be well understood.
28. Amber is an MSL and receives a question This is an unsolicited request.
from a physician about a medication indica- This information is off-label.
tion that is not FDA approved. Which of the
following is true?
29. A Pharma company is looking to begin the To provide their opinion on the research
development of a new drug. Why would the and development of the drug
company consult an advisory board?
30. False
Study online at https://quizlet.com/_bj1aoj
1. Most commonly used study design: parallel
2. Under what conditions can a pharma compa- The grants/contributions are separate
ny provide financial support for conferences from other company funds
and CME?
The company has had no control over
the selection of content, faculty, or
venue
3. Not required by ADR reporting: careful selection of clinical trial partici-
pants
Required:
-recognition of events
-safety signals are identified against a
background of events
-accurate reporting
4. Individual board members are known as: advisors
5. in vitro diagnostic test - example microbiology culture
6. 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"
7. Fundamental requirement for ongoing risk timely data collection
evaluations of REMS:
8. Best practice and ethical standards for re- ICMJE
porting research published in medical jour-
nals
, BCMAS Exam
Study online at https://quizlet.com/_bj1aoj
9. T/F: Elements to Assure Safe Use (ETASU) True
are required medical interventions taken by
HCPs prior to using the drug.
10. Combination product applicant(s) The company that holds the application
for the combination product as a whole
11. T/F: Severe birth defects is not an FDA man- False
dated REMS.
12. Export challenge of a medical device compa- Violation of intellectual property rights
ny:
13. Purposes of IIS develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
NOT a purpose = support pt community
14. Goals of pharmacogenomics Individualize therapies based on genet-
ic 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 ad-
herence
15. FDA clearance for medical devices May be given for devices with substan-
tial equivalence to a known predicate
device
Allows the device to be marketed and
, BCMAS Exam
Study online at https://quizlet.com/_bj1aoj
sold once a Pre-Market Notification has
been submitted
May be issued if the device existed in
the market prior to 1976
16. EBM databases DynaMed
Cochrane Library
17. T/F: Presentation skills are not essential for False
maintaining a position with MA.
18. What would cause the FDA to require If the FDA becomes aware of new safety
post-marketing studies or clinical trials at the information from SADR reporting.
time of approval or afterwards for a new
product?
19. When first working on a publication, what Document the agreement
should authors do to identify their rights,
roles, and responsibilities?
20. The process of internal cooperation, coordi- Harmonization
nation, and common standards across the
global pharmaceutical industry is referred to
as:
21. 5-step process to respond to a medical infor- 1) Determine who the audience is
mation question 2) Understand what the primary ques-
tion is
3) Develop an appropriate research
strategy
4) Choose the best source
, BCMAS Exam
Study online at https://quizlet.com/_bj1aoj
5) Assess the information source and
answer the question
22. T/f: SRDs are prepared only for HCPs in re- False
sponse to questions about product(s).
23. Who is required to submit a periodic safety Marketing authorization holders
update report? (MAHs) according to the data points
outlined in the EURD list.
24. T/F: Surveys are classified as cross-sectional True
studies.
25. Medical Device User Fees Amendment of Allows the FDA to collect user fees for
2012 pre-market approvals to improve the
overall review process
26. T/F: An abbreviated new drug application True
(ANDA) is submitted to the FDA for generic
drugs.
27. The risk associated with this type of drug may New drug substance
not be well understood.
28. Amber is an MSL and receives a question This is an unsolicited request.
from a physician about a medication indica- This information is off-label.
tion that is not FDA approved. Which of the
following is true?
29. A Pharma company is looking to begin the To provide their opinion on the research
development of a new drug. Why would the and development of the drug
company consult an advisory board?
30. False
