Regulatory considerations for vaccine development, talk 2 [electronic resource] : clinical regulatory considerations (part 2 of 2) / Lewis K. Schrager.
Material type:
FilmSeries: Henry Stewart talksBiomedical & life sciences collection. Vaccines: Publisher: London : Henry Stewart Talks, 2015Description: 1 online resource (1 streaming video file (35 min.) : color, sound)Other title: Clinical regulatory considerations. Part 2Subject(s): United States. Food and Drug Administration | Vaccines industry -- Government policy -- United States | Vaccines -- Development | Animal Testing Alternatives | Biological Products -- standards | Clinical Trials as Topic -- legislation & jurisprudence | Drug Approval -- methods | Drug Evaluation, Preclinical | Drug Industry -- legislation & jurisprudence | Investigational New Drug Application -- legislation & jurisprudence | Investigational New Drug Application -- methods | 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: Biological License Application (BLA) pathways -- Traditional, accelerated approval, "Animal Rule" -- Programs that accelerate the clinical testing (IND) and review (BLA) processes -- Fast track designation -- Breakthrough designation -- Priority review -- The package insert -- Pediatric study requirements -- Adjuvants -- Adaptive trial design from a regulatory perspective -- Developing vaccines for global infectious diseases.
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Mode of access: World Wide Web.