Regulatory considerations for vaccine development, talk 1 [electronic resource] : chemistry, manufacturing and control / Norman W. Baylor.
Material type:
FilmSeries: Henry Stewart talksBiomedical & life sciences collection. Vaccines: Publisher: London : Henry Stewart Talks, 2015Description: 1 online resource (1 streaming video file (31 min.) : color, sound)Other title: Chemistry, manufacturing and controlSubject(s): 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 -- standardsOnline resources: Click here to access online | Series Animated audio-visual presentation with synchronized narration.
Title from title frames.
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.
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Mode of access: World Wide Web.