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Regulatory considerations for vaccine development, talk 1 : chemistry, manufacturing and control / Norman W. Baylor.

Henry Stewart Biomedical & Life Sciences Collection Available online

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Format:
Video
Author/Creator:
Baylor, Norman W., (Biologics Consulting Group, Inc., USA), Speaker.
Series:
Henry Stewart talks. Biomedical & life sciences collection. Vaccines.
Vaccines : principles, recent developments and future directions, 2056-452X
Language:
English
Subjects (All):
Vaccines industry--Government policy--United States.
Vaccines industry.
Vaccines--Development.
Vaccines.
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.
United States. Food and Drug Administration.
United States.
Medical Subjects:
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.
Physical Description:
1 videorecording (31 min., 18 sec.) : sound, color
Other Title:
Chemistry, manufacturing and control
Place of Publication:
London : Henry Stewart Talks, 2015.
System Details:
video file
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:
Description based on publisher supplied metadata and other sources.
Animated audio-visual presentation with synchronized narration.
Title from title frames.
Publisher Number:
4038 Henry Stewart Talks

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