Qualitative Models: Information Flow, Decision Making, Risk Archetypes, Regulatory Control, Policy Resistance, Healthcare Information Technology Design Controls/Safety, Clinical System Complexity Metrics, etc.
Control structure for pharmaceutical research, development, regulation and safety surveillance
This diagram represents major interactions that influence pharmaceutical R&D, regulatory review/approval, prescribing behaviors and post-market surveillance. 'Interactions' may represent direct interface between representatives of various agencies (e.g., FDA, pharmaceutical corporation, healthcare provider, Federal research funder, etc.), or indirect. The nature of the interaction may include: data/information exchange, application, adverse event report, enforcement action, payment, policy enactment, publication, or direct encounter (e.g., a prescribing event between a patient and provider). This is a brief set of examples of what represents a large and diverse range of interactions that might occur. The strength and effect of the interactions vary, as well.
© Meghan M. Dierks, MD
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