TY  - ADVS
AU  - Tremmel,Lothar
TI  - A structured approach for pharmaceutical pre-marketing safety surveillance
T2  - The biomedical & life sciences collection,
PY  - 2021///
CY  - London
PB  - Henry Stewart Talks
KW  - United States
KW  - Food and Drug Administration
KW  - Drug approval
KW  - Drugs
KW  - Safety regulations
KW  - Testing
KW  - Adverse Drug Reaction Reporting Systems
KW  - standards
KW  - Drug Approval
KW  - methods
KW  - Drug Development
KW  - Drug Evaluation, Preclinical
KW  - Evaluation Studies as Topic
KW  - Medical Informatics
KW  - trends
KW  - Pharmacovigilance
KW  - Product Surveillance, Postmarketing
KW  - Risk Assessment
N1  - 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
UR  - https://hstalks.com/bs/4771/
ER  -