|
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)
|
