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BCMAS
1. )
TRUE/FALSE The Medical affairs team works with KOLs and
prescribers as consultants for the study: True
2. Under what conditions can a pharma company provide financial
support for conferences and CME? Check all that apply.: -The grants/contributions
are separate from other company funds (such as sales or marketing)
-The company has had no control over the selection of content, faculty,or venue
3. Specific tasks conducted by MSLs include which of the following:
Select all that apply: -helping to identify ongoing concerns of external stakeholders
-identifying unmet needs of investigators
-identifying data gaps
4. The process of international cooperation, coordination, and
common stan- dards across the global pharmaceutical industry is
referred to as:: Harmonization
5. Which statements about generic drugs are true? Select all that
apply.: -The intended use must be the same as the comparable brand name drug.
-The quality must be the same as the comparable brand name drug.
-The dosage form must be the same as the comparable brand name drug.
6. What is a driver that influences market growth and trends?: Increased
prevalence of infectious diseases
7. TRUE/FALSE MSL teams can be as small as 1 or larger than 100
people.: TRUE
8. Which one is an FDA requirement for labeling for IVD products?:
Intended use of the product
9. TRUE/FALSE Exclusivity provides a company the exclusive
marketing of a drug.: True
10. TRUE/FALSE Post-Marketing Commitments (PMCs) include
study designs not mandated by the FDA.: TRUE
11. A REACTIVE interaction between a pharma representative and
HCP takes place when:: An interaction results from an HCP making an unsolicited inquiry to
learn about a drug, and possibly an ott-label use
12. Which of the following is a recommendation from the GPP
guidelines?: All authors and contributors should disclose any relationships or potential
1/
5
, More Study Sets
BCMAS
competing interests relating to the research
2/
5
BCMAS
1. )
TRUE/FALSE The Medical affairs team works with KOLs and
prescribers as consultants for the study: True
2. Under what conditions can a pharma company provide financial
support for conferences and CME? Check all that apply.: -The grants/contributions
are separate from other company funds (such as sales or marketing)
-The company has had no control over the selection of content, faculty,or venue
3. Specific tasks conducted by MSLs include which of the following:
Select all that apply: -helping to identify ongoing concerns of external stakeholders
-identifying unmet needs of investigators
-identifying data gaps
4. The process of international cooperation, coordination, and
common stan- dards across the global pharmaceutical industry is
referred to as:: Harmonization
5. Which statements about generic drugs are true? Select all that
apply.: -The intended use must be the same as the comparable brand name drug.
-The quality must be the same as the comparable brand name drug.
-The dosage form must be the same as the comparable brand name drug.
6. What is a driver that influences market growth and trends?: Increased
prevalence of infectious diseases
7. TRUE/FALSE MSL teams can be as small as 1 or larger than 100
people.: TRUE
8. Which one is an FDA requirement for labeling for IVD products?:
Intended use of the product
9. TRUE/FALSE Exclusivity provides a company the exclusive
marketing of a drug.: True
10. TRUE/FALSE Post-Marketing Commitments (PMCs) include
study designs not mandated by the FDA.: TRUE
11. A REACTIVE interaction between a pharma representative and
HCP takes place when:: An interaction results from an HCP making an unsolicited inquiry to
learn about a drug, and possibly an ott-label use
12. Which of the following is a recommendation from the GPP
guidelines?: All authors and contributors should disclose any relationships or potential
1/
5
, More Study Sets
BCMAS
competing interests relating to the research
2/
5
