What role of Medical Affairs is responsible for documenting and reporting adverse events, side effects,
and safety issues? - Pharmacovigilance
Many of the origins of the pharmaceutical industry originated in what country? - Germany
Which of the following are part of the SMART paradigm for medical affairs goals? Check all that apply. -
Measurable
Specific
Relatable
Which of the following is NOT part of the five-step drug development process? - Sales and marketing
strategies
Which statement is true about public pharmaceutical companies? - 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: - 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? - Provide physicians and patients with accurate, ethical, and unbiased drug
information
The Medical Dictionary for Regulatory Activities (MedDRA) and the Common Technical Document (CTD)
were developed through the work of: - International Council for Harmonization (ICH)
Which of the following are primary pharmaceutical regulators in the United States? Check all that apply.
- Department of Justice (DoJ)
Food and Drug Administration (FDA)
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