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Regulatory considerations for vaccine development, talk 1 chemistry, manufacturing and control
Title
Regulatory considerations for vaccine development, talk 1 [electronic resource] : chemistry, manufacturing and control / Norman W. Baylor.
Published
London : Henry Stewart Talks, 2015.
Physical Description
1 online resource (1 streaming video file (31 min.) : color, sound).
Local Notes
Access is available to the Yale community.
Notes
Animated audio-visual presentation with synchronized narration.
Title from title frames.
Access and use
Access restricted by licensing agreement.
Variant and related titles
Chemistry, manufacturing and control
Format
Images / Online / Video & Film
Language
English
Added to Catalog
February 18, 2016
Series
Vaccines : principles, recent developments and future directions,
System details note
Mode of access: World Wide Web.
System requirements: Browser compatibility: updated Mozilla Firefox, Google Chrome, Safari or Internet Explorer 8+. Browser settings: enable JavaScript, enable cookies from the Henry Stewart Talks site. Required Desktop Browser plugins & viewers: Updated Adobe Flash Player & Adobe Acrobat Reader. Mobile device & operating system versions: Android v2.1+, iPhone 4+ (iOS v5.x+), iPad 2+ (iOS v5.x+), BlackBerry OS v7.0+, Windows Phone v6.5.1+.
Contents
Contents: Functions of the FDA/CBER/OVRR
Definition and types of vaccines
Evolution & legal framework for vaccine regulations
Drug substance and product
CMC development
Vaccine manufacturing
Preclinical evaluation
Process validation
Novel technologies.
Publisher's number
4038 Henry Stewart Talks
Subjects
Subjects (Medical)
Clinical Trials as Topic - legislation & jurisprudence.
Drug and Narcotic Control.
United States Food and Drug Administration - legislation & jurisprudence.
United States Food and Drug Administration - standards.
Bookmark As
Citation
