STUDY MORE BCMAS 2 | BOARD CERTIFIED MEDICAL AFFAIRS
SPECIALIST PRACTICE QUESTIONS & EXAM REVIEW 2026/2027
Which of the following is defined as, "the study of variations of DNA and RNA characteristics as related
to drug response"? - ANS ✔✔Pharmacogenomics
A proactive interaction between a pharma representative and HCP takes place when: - ANS ✔✔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. - ANS ✔✔-They are
qualitative summaries
-Reporting bias is considered a limitation
What law requires companies and manufacturers to publish their interactions with HCPs? - ANS ✔✔The
Physician Payments Sunshine Act
What is ADR reporting? - ANS ✔✔Passive approach to identifying safety signals
What is an example of cost-effectiveness analysis (CEA)? - ANS ✔✔Osteoporosis Drug A versus Drug B on
fracture risk reduction ($/fracture avoided)
What is an economic challenge that medical device manufacturers face? - ANS ✔✔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
- ANS ✔✔-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. - ANS ✔✔-
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? - ANS ✔✔Class I
What program requires companies to report certain payments to the federal government? - ANS ✔✔The
National Physician Payment Transparency Program
What is a Scientific Platform? - ANS ✔✔An important guide in developing the publication plan for the
product
Under the third-tier compliance regulations, which statement best describes 21 CFR part 7? - ANS
✔✔Enforcement Policy for drugs and medical devices
SPECIALIST PRACTICE QUESTIONS & EXAM REVIEW 2026/2027
Which of the following is defined as, "the study of variations of DNA and RNA characteristics as related
to drug response"? - ANS ✔✔Pharmacogenomics
A proactive interaction between a pharma representative and HCP takes place when: - ANS ✔✔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. - ANS ✔✔-They are
qualitative summaries
-Reporting bias is considered a limitation
What law requires companies and manufacturers to publish their interactions with HCPs? - ANS ✔✔The
Physician Payments Sunshine Act
What is ADR reporting? - ANS ✔✔Passive approach to identifying safety signals
What is an example of cost-effectiveness analysis (CEA)? - ANS ✔✔Osteoporosis Drug A versus Drug B on
fracture risk reduction ($/fracture avoided)
What is an economic challenge that medical device manufacturers face? - ANS ✔✔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
- ANS ✔✔-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. - ANS ✔✔-
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? - ANS ✔✔Class I
What program requires companies to report certain payments to the federal government? - ANS ✔✔The
National Physician Payment Transparency Program
What is a Scientific Platform? - ANS ✔✔An important guide in developing the publication plan for the
product
Under the third-tier compliance regulations, which statement best describes 21 CFR part 7? - ANS
✔✔Enforcement Policy for drugs and medical devices
