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Workshop - Evaluation of New Vaccines: How Much Safety Data? (Day 2)

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Air date: Wednesday, November 15, 2000, 8:30:00 AM
Time displayed is Eastern Time, Washington DC Local
Views: Total views: 89 * This only includes stats from October 2011 and forward.
Category: Conferences
Runtime: 06:21:01
Description: FDA/Center for Biologics Evaluation and Research

The motivation for this workshop arises from the importance of ensuring that optimal approaches are taken to the safety evaluation of new vaccines. While it is clear that very rare adverse reactions to vaccines will not likely ever be identifiable in randomized, controlled trials performed in support of licensure, the threshold for adverse event rates that should be reliably detected in these trials is worthy of discussion. This workshop will address the feasibility and desirability of performing larger prelicensure trials of vaccines in order to provide more precise measures of safety prior to widespread use. It will also invite discussion of the optimal balance between pre-licensure and post-licensure evaluation of vaccine safety.

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Workshop - Evaluation of New Vaccines: How Much Safety Data?
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NLM Title: Workshop--evaluation of new vaccines : how much safety data?
Author: National Institutes of Health (U.S.)
Subjects: Clinical Trials as Topic
Drug Evaluation
Product Surveillance, Postmarketing
Research Design
Publication Types: Webcasts
Rights: This is a work of the United States Government. No copyright exists on this material. It may be disseminated freely.
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NLM Classification: QW 805
NLM ID: 101267522
CIT Live ID: 475
Permanent link: