Regulatory considerations for vaccine development, talk 2 clinical regulatory considerations (part 2 of 2) /

Regulatory considerations for vaccine development, talk 2 clinical regulatory considerations (part 2 of 2) /

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Bibliographic Details
Other Authors: Schrager, Lewis K. (Speaker)
Format: Electronic Video
Language:English
Published: London : Henry Stewart Talks, 2015.
Series:Henry Stewart talks. Biomedical & life sciences collection. Vaccines.
Subjects:
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 > standards.
Online Access:https://hstalks.com/bs/3170/
Series
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245 1 0 |a Regulatory considerations for vaccine development, talk 2  |h [electronic resource] :  |b clinical regulatory considerations (part 2 of 2) /  |c Lewis K. Schrager. 
246 3 |a Clinical regulatory considerations. Part 2 
260 |a London :  |b Henry Stewart Talks,  |c 2015. 
300 |a 1 online resource (1 streaming video file (35 min.) :  |b color, sound). 
490 1 |a Vaccines : principles, recent developments and future directions,  |x 2056-452X 
500 |a Animated audio-visual presentation with synchronized narration. 
500 |a Title from title frames. 
505 0 |a 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. 
506 |a Access restricted to subscribers. 
538 |a Mode of access: World Wide Web. 
610 1 0 |a United States.  |b Food and Drug Administration.  |9 100422 
650 0 |a Vaccines industry  |x Government policy  |z United States.  |9 100423 
650 0 |a Vaccines  |x Development.  |9 100424 
650 2 |a Animal Testing Alternatives.  |9 100425 
650 2 |a Biological Products  |x standards.  |9 100426 
650 2 |a Clinical Trials as Topic  |x legislation & jurisprudence.  |9 100427 
650 2 |a Drug Approval  |x methods.  |9 100428 
650 2 |a Drug Evaluation, Preclinical.  |9 100429 
650 2 |a Drug Industry  |x legislation & jurisprudence.  |9 100430 
650 2 |a Investigational New Drug Application  |x legislation & jurisprudence.  |9 100431 
650 2 |a Investigational New Drug Application  |x methods.  |9 100432 
650 2 |a United States Food and Drug Administration  |x legislation & jurisprudence.  |9 100433 
650 2 |a United States Food and Drug Administration  |x standards.  |9 100434 
650 2 |a Vaccines  |x standards.  |9 100435 
830 0 |a Henry Stewart talks.  |p Biomedical & life sciences collection.  |p Vaccines.  |9 100436 
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