BCMAS 2 QUESTIONS AND ANSWERS
Which of the following is defined as, "the study of variations of DNA and RNA
characteristics as related to drug response"? - Answer -Pharmacogenomics
A proactive interaction between a pharma representative and HCP takes place when: -
Answer -The pharma company representative initiates the interaction to provide product
information to the HCP
Which of the following is true regarding systematic reviews? Check all that apply. -
Answer --They are qualitative summaries
-Reporting bias is considered a limitation
What law requires companies and manufacturers to publish their interactions with
HCPs? - Answer -The Physician Payments Sunshine Act
What is ADR reporting? - Answer -Passive approach to identifying safety signals
What is an example of cost-effectiveness analysis (CEA)? - Answer -Osteoporosis
Drug A versus Drug B on fracture risk reduction ($/fracture avoided)
What is an economic challenge that medical device manufacturers face? - Answer -
High costs of raw materials and required personnel
How does the role of pharmacovigilance work to assure the safety of drug products?
Select all that apply - Answer --Identifies safety signals
-Establishes a method for analyzing data to detect safety problems
-Collects adverse event data
What types of testing can take place at the Pre-Clinical Research phase? Select all that
apply. - Answer --In-Vivo Testing
-In-Vitro Testing
A company in the United States has completed work on a medical device and wants to
take it to market. The device is a cane with a handle that adjusts to different heights.
Which medical device classification should be selected when determining what FDA
approval process is needed? - Answer -Class I
What program requires companies to report certain payments to the federal
government? - Answer -The National Physician Payment Transparency Program
What is a Scientific Platform? - Answer -An important guide in developing the
publication plan for the product
Which of the following is defined as, "the study of variations of DNA and RNA
characteristics as related to drug response"? - Answer -Pharmacogenomics
A proactive interaction between a pharma representative and HCP takes place when: -
Answer -The pharma company representative initiates the interaction to provide product
information to the HCP
Which of the following is true regarding systematic reviews? Check all that apply. -
Answer --They are qualitative summaries
-Reporting bias is considered a limitation
What law requires companies and manufacturers to publish their interactions with
HCPs? - Answer -The Physician Payments Sunshine Act
What is ADR reporting? - Answer -Passive approach to identifying safety signals
What is an example of cost-effectiveness analysis (CEA)? - Answer -Osteoporosis
Drug A versus Drug B on fracture risk reduction ($/fracture avoided)
What is an economic challenge that medical device manufacturers face? - Answer -
High costs of raw materials and required personnel
How does the role of pharmacovigilance work to assure the safety of drug products?
Select all that apply - Answer --Identifies safety signals
-Establishes a method for analyzing data to detect safety problems
-Collects adverse event data
What types of testing can take place at the Pre-Clinical Research phase? Select all that
apply. - Answer --In-Vivo Testing
-In-Vitro Testing
A company in the United States has completed work on a medical device and wants to
take it to market. The device is a cane with a handle that adjusts to different heights.
Which medical device classification should be selected when determining what FDA
approval process is needed? - Answer -Class I
What program requires companies to report certain payments to the federal
government? - Answer -The National Physician Payment Transparency Program
What is a Scientific Platform? - Answer -An important guide in developing the
publication plan for the product
