BCMAS QUESTIONS & ANSWERS
TRUE/FALSE The Medical affairs team works with KOLs and prescribers as consultants
for the study
True
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
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
The process of international cooperation, coordination, and common standards across
the global pharmaceutical industry is referred to as:
Harmonization
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.
What is a driver that influences market growth and trends?
Increased prevalence of infectious diseases
TRUE/FALSE MSL teams can be as small as 1 or larger than 100 people.
TRUE
Which one is an FDA requirement for labeling for IVD products?
Intended use of the product
TRUE/FALSE The Medical affairs team works with KOLs and prescribers as consultants
for the study
True
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
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
The process of international cooperation, coordination, and common standards across
the global pharmaceutical industry is referred to as:
Harmonization
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.
What is a driver that influences market growth and trends?
Increased prevalence of infectious diseases
TRUE/FALSE MSL teams can be as small as 1 or larger than 100 people.
TRUE
Which one is an FDA requirement for labeling for IVD products?
Intended use of the product
