Title: Lessons learned from the current influenza H1N1v pandemic and its potential consequences for future regulatory preparedness in particular for the authorisation of pandemic influenza vaccines.
Author: Ehman, Falk
Institution: Institute of Tropical Medicine and International Health, Berlin
Graduate date: 2010-07-07 (W3C-DTF)
Document: Abstract_Ehmann,Falk_2010.doc
One objective of this thesis is to compare and analyse the regulatory pathways for the authorization of pandemic influenza vaccines especially in light of the respective data requirements for a marketing authorisation. Strengths and shortcomings of the 3 pathways will be analysed in respect to the experience gained during the current influenza H1N1v pandemic. The question whether the regulatory preparedness was appropriate to meet the needs for the current H1N1v influenza pandemic will be discussed. The question whether there is a need to change, modify or amend the current regulatory framework for the authorisation of pandemic vaccines in order to guarantee a better preparedness in terms of timely available vaccines for future influenza pandemics is discussed.
Classification: 2010 (LCSH)
Language: English
Date Of Record Creation: 2012-09-17 15:52:08 (W3C-DTF)
Date Of Record Release: 2012-09-17 15:52:54 (W3C-DTF)
Date Last Modified: 2012-09-17 15:53:33 (W3C-DTF)

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