Exam (elaborations)
BCMAS 1, 2 AND 3 PHARMA, MEDICAL DEVICE, & IVD INDUSTRIES QUESTIONS AND ANSWERS
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BCMAS 1, 2 AND 3 PHARMA, MEDICAL DEVICE, & IVD INDUSTRIES QUESTIONS AND ANSWERS
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Name: Score:23 Multiple choice questions
Term 1 of 23
A scientist working at a pharm company discovers a currently commercialized beta blocker
which fits well into the company's current cardiovascular product portfolio. To which team
should she communicate the information to?
legal
business development
R&D
medical affairs
Term 2 of 23
Labeling for the prescribing information takes place
during post-market research
after NDA is approved
after FDA determines the drug is safe and effective
before IND is filed
Term 3 of 23
Point-of-care testing pros and cons?
- non invasive & certified by CMS
- for home use & follows CLIA standards
Pros: low cost, less complex, rapid testing
Cons: less sensitive, require training
- MHRA (Medicines & Healthcare Products Regulatory Agency)
- WHO
- aging population
- increased income & changing lifestyle
- increase in chronic diseases
,Term 4 of 23
Difference between in vivo and in vitro?
In vivo diagnostics are tests that involve body fluids or tissues (IN the body, in vitro are
OUT of the body, like in test tubes)
In vivo diagnostics are only applicable to animals, while in vitro are for humans
In vivo diagnostics are only for external tests, while in vitro are for internal examinations
In vivo diagnostics are performed in laboratories, while in vitro are done in hospitals
Term 5 of 23
The sequence best describing supply chain process is:
raw material -> distributors -> manufacturing units
raw material -> regional warehouses -> central warehouse
raw material -> manufacturing units -> distributors
raw material -> distributors -> central warehouses
Term 6 of 23
One of the most important regulating agencies is the FDA's _________.
Food safety and inspection service (fsis)
Environmental protection agency (epa)
Center for the Drug Evaluation and Research (CDER)
National institutes of health (nih)
, Term 7 of 23
Name three drivers of growth for the pharma industry.
- aging population
- increased income & changing lifestyle
- increase in chronic diseases
- MHRA (Medicines & Healthcare Products Regulatory Agency)
- WHO
- API, forumlations manufacturers, and contract research & manufacturing services
(CRAMS)
- API, generic, & patented drugs
- non invasive & certified by CMS
- for home use & follows CLIA standards
Term 8 of 23
True or False: the FDA requires the class of the medical device on IVD products.
True
False
Term 9 of 23
A test may be waived by the FDA if what? (Two things)
Center for the Drug Evaluation and Research (CDER)
- aging population
- increased income & changing lifestyle
- increase in chronic diseases
- non invasive & certified by CMS
- for home use & follows CLIA standards
- MHRA (Medicines & Healthcare Products Regulatory Agency)
- WHO
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