BCMAS Study Questions and Answers (Graded A)BCMAS Study Questions and Answers (Graded A)BCMAS Study Questions and Answers (Graded A)BCMAS Study Questions and Answers (Graded A)
What role of Medical Affairs is responsible for documenting and reporting adverse events, side effects, and safety issues...
BCMAS Study Questions and Answers (Graded A)
What role of Medical Affairs is responsible for documenting and reporting adverse events, side effects, and safety issues? - ANSWER-Pharmacovigilance
Many of the origins of the pharmaceutical industry originated in what country? - ANSWER-Germany
Which of the following are part of the SMART paradigm for medical affairs goals? Check
all that apply. - ANSWER-Measurable
Specific
Relatable
True/False Determining what data will be published is an important part of the publication plan. - ANSWER-TRUE
In what year were the first GPP guidelines published? - ANSWER-2003
What is one of the most important tasks for a medical affairs team? - ANSWER-Choose the KOLs/physicians who will serve as authors for different publications
Which of the following is NOT part of the five-step drug development process? - ANSWER-Sales and marketing strategies
Which statement is true about public pharmaceutical companies? - ANSWER-They are required to release information detailing how they will commercialize their product
The process of international cooperation, coordination, and common standards across the global pharmaceutical industry is referred to as: - ANSWER-Harmonization
Ashley is an MSL involved in reviewing drug promotional materials for a newly approved
medication for hypertension. Which of the following would be a goal for Ashley at her medical-legal-regulatory review meeting tomorrow? - ANSWER-Provide physicians and patients with accurate, ethical, and unbiased drug information
What type of manufacturers conduct research and manufacture drugs under licenses from other companies? - ANSWER-CRAMS (Contract Research and Manufacturing Services)
When first working on a publication, what should authors do to identify their rights, roles,
and responsibilities? - ANSWER-Document the agreement
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