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Book Cover
Streaming video
Author Baylor, Norman W., (Biologics Consulting Group, Inc., USA), speaker

Title Regulatory considerations for vaccine development, talk 1 : chemistry, manufacturing and control / Norman W. Baylor
Published London : Henry Stewart Talks, 2015
Online access available from:
HSTalks Biomedical & Life Sciences Collection    View Resource Record  


Description 1 online resource (1 streaming video file (31 min.) : color, sound)
Series Vaccines : principles, recent developments and future directions, 2056-452X
Henry Stewart talks. Biomedical & life sciences collection. Vaccines
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
Notes Animated audio-visual presentation with synchronized narration
Title from title frames
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 v4.0+, iPhone 4+ (iOS v6.x+), iPad 2+ (iOS v6.x+), BlackBerry OS v7.0+, Windows Phone v6.5.1+
Subject United States. Food and Drug Administration.
Vaccines industry -- Government policy -- United States.
Vaccines -- Development.
Clinical Trials as Topic -- legislation & jurisprudence.
Drug and Narcotic Control.
Drug Approval -- methods.
Drug Industry -- legislation & jurisprudence.
United States Food and Drug Administration -- legislation & jurisprudence.
United States Food and Drug Administration -- standards.
Vaccines -- standards.
Genre/Form Video recordings.
Form Streaming video
Other Titles Chemistry, manufacturing and control