Visions of CBER for Vaccine Manufacturing

GMP News
18 June 2008
 

Visions of CBER for Vaccine Manufacturing

  
On the occasion of the World Vaccine Congress on 22 April 2008, Karen Midthun from the Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) presented the center's visions for the field of vaccine manufacturing:

  • protect and improve the public health in USA and, where feasible globally

  • facilitate the development, approval and access to safe and effective products and promising new technologies

  • strengthen CBER as a pre-eminent regulatory organisation for biologics

  • In her presentation, Karen Midthun highlighted five major vaccine initiatives. One of these initiatives is enhancing product safety integrating the CBER vaccine safety team and the informatic data. Furthermore, they want to restore the collaboration with other human health agencies and vaccine safety initiatives.
    Another point is the manufacturing and product quality activities which are, among others, engaged in risk based compliance programmes which should evaluate existing programmes and expand them to new areas.

    The CBER activities showed the increasing global character of collaboration between national and international authorities and the thereby emerging requirements for the vaccine manufacturers.

    More more about the CBER visions here:
    http://www.fda.gov/cber/summaries/wvc042208km.pdf

    More about the CBER vaccine safety team is available here:
    http://www.fda.gov/cber/summaries/fldi032708cc.pdf

    Author:
    Axel H. Schroeder
    On behalf of the European Compliance Academy (ECA)
     

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