Global CMC Requirements - Quality data for marketing authorisations outside the ICH region

This seminar will focus on the CMC
requirements outside the ICH region.
Which data and which formats have
to be provided for a marketing
authorisation?

Two CMC experts will give you a detailed
overview of the general requirements
and pass on their in-depth knowledge of
the American, Russian and Asian markets.

After attending the seminar you will have
a good understanding of your CMC duties
in the various regions and will have new
input on how to set up global stability
programmes.