Tremmel, Lothar,
A structured approach for pharmaceutical pre-marketing safety surveillance [electronic resource] / Lothar Tremmel. - London : Henry Stewart Talks, 2021. - 1 online resource (1 streaming video file (41 min.) : color, sound). - The biomedical & life sciences collection, 2056-452X . - Henry Stewart talks. Biomedical & life sciences collection. .
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).
Access restricted to subscribers.
Mode of access: World Wide Web.
5570 Henry Stewart Talks
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 Assessment.
A structured approach for pharmaceutical pre-marketing safety surveillance [electronic resource] / Lothar Tremmel. - London : Henry Stewart Talks, 2021. - 1 online resource (1 streaming video file (41 min.) : color, sound). - The biomedical & life sciences collection, 2056-452X . - Henry Stewart talks. Biomedical & life sciences collection. .
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).
Access restricted to subscribers.
Mode of access: World Wide Web.
5570 Henry Stewart Talks
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 Assessment.