ECU Libraries Catalog

Regulatory considerations for vaccine development, talk 2 : clinical regulatory considerations (part 2 of 2) / Lewis K. Schrager.

Author/creator Schrager, Lewis K. speaker.
Other author/creatorHenry Stewart Talks (Firm)
Format Electronic and Video (Streaming)
Publication Info London : Henry Stewart Talks, 2015.
Description1 streaming video file (35 min.) : color, sound.
Supplemental Content Direct link to resource
Subject(s)
Variant title Clinical regulatory considerations. Part 2
Series Vaccines : principles, recent developments and future directions
Biomedical & life sciences collection. Vaccines. UNAUTHORIZED
Contents 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.
General noteAnimated audio-visual presentation with synchronized narration.
Technical detailsMode of access: World Wide Web.
Technical detailsSystem 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 v2.1+, iPhone 4+ (iOS v5.x+), iPad 2+ (iOS v5.x+), BlackBerry OS v7.0+, Windows Phone v6.5.1+.
Source of descriptionTitle from title frames [viewed January 22, 2016]
Publisher number4161 Henry Stewart Talks

Available Items

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Electronic Resources Access Content Online ✔ Available
Electronic Resources Access Content Online ✔ Available