A structured approach for pharmaceutical pre-marketing safety surveillance [electronic resource] / Lothar Tremmel.
Material type:
FilmSeries: Henry Stewart talksBiomedical & life sciences collection: Publisher: London : Henry Stewart Talks, 2021Description: 1 online resource (1 streaming video file (41 min.) : color, sound)Subject(s): United States. Food and Drug Administration | Drug approval | Drugs -- Safety regulations | Drugs -- Testing | Adverse Drug Reaction Reporting Systems -- standards | Drug Approval -- methods | Drug Development -- standards | Drug Evaluation, Preclinical | Evaluation Studies as Topic | Medical Informatics -- trends | Pharmacovigilance | Product Surveillance, Postmarketing | Risk AssessmentOnline resources: Click here to access online Animated audio-visual presentation with synchronized narration.
Title from title frames.
Contents: Key-concepts in safety surveillance -- Pre-marketing and post-marketing surveillance -- Assessing drug-event relatedness via increased frequency analysis -- The FDA's final rule on IND safety reporting -- Surveilling for unknown unknowns -- Providing context and perspective to emerging suspected safety issues -- The importance of interdisciplinary collaboration -- The Aggregate Safety Assessment Plan (ASAP).
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Mode of access: World Wide Web.