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GMP meets Regulatory Affairs - Prague, Czech Rep


2018, April 23 - 24

Pharmaceutical » Training


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


Venue

Prague
Czech Republic

Organizer

Concept Heidelberg
Phone: +[49] 62 21/84 44 0
Email: info@concept-heidelberg.de
Visit organizer website



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