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A structured approach for pharmaceutical pre-marketing safety surveillance / Lothar Tremmel.
- Format:
- Video
- Author/Creator:
- Tremmel, Lothar, (CSL Behring, USA), Speaker.
- Series:
- Henry Stewart talks. Biomedical & life sciences collection.
- The biomedical & life sciences collection, 2056-452X
- Language:
- English
- Subjects (All):
- Drug approval.
- Drugs--Safety regulations.
- Drugs.
- 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.
- United States. Food and Drug Administration.
- United States.
- Medical Subjects:
- 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.
- Physical Description:
- 1 online resource (1 streaming video file (41 min.)) : sound, color
- Place of Publication:
- London : Henry Stewart Talks, 2021.
- System Details:
- video file
- Contents:
- 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).
- Notes:
- Description based on publisher supplied metadata and other sources.
- Animated audio-visual presentation with synchronized narration.
- Title from title frames.
- Publisher Number:
- 5570 Henry Stewart Talks
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