During this course you will get to know the relevant aspects of applying for and maintaining a marketing authorisation in the ICH countries. You will learn what you need to know from a GMP perspective about:
- the basic requirements for drug approval in Europe, the US and Japan
- the structure of the marketing authorisation dossier according to the CTD
- the input from the GMP regulated departments
- drug approval procedures in the EU and US
- documents to be provided and timelines to be observed
- how to handle changes and variations in the EU, the US and Japan
For details and registration - www.gmp-compliance.org
