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GMP meets Regulatory Affairs - Prague, Czech Rep

: 23 Apr 2018 - 24 Apr 2018

: Prague, Czech Republic

Sector: Pharmaceutical

Type: 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: http://www.gmp-navigator.com


<< Previous article
Microbiological Cont...
Next article > >
Workshop “Data Int...