23.-24.11.2017

Barcelona: Drug Master File Procedures in the EU, the US and Japan

In this two days conference, Dr. Hiltrud Horn will give detailed insight into the Drug Master File Procedures in the US. You will learn how to prepare the US-DMF and will get latest updates on current CMC-trends and how you can benefit from those. Furthermore she will guide you through the major differences to be considered for US- and EU-DMFs. In addition you will get practical advice on how to deal with post-approval changes in US. You will understand the FDA and their approach in dealing with your changes. After this course you will know the essentials that a CMC-expert needs for preparing US-DMFs and ASMFs.

 

For more information please visit the following website:

https://www.gmp-navigator.com/daten/seminarpdf/ECA-Drug-Master-File-Procedures.pdf

 

(Conference organized by Concept Heidelberg)



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  • 26.07.2013
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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
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