21. - 22.10.2014
Budapest: 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 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.
For more information please visit the following website:
http://www.gmp-navigator.com/daten/seminarpdf/ECA_DMF_2014.pdf
(Conference organized by Concept Heidelberg)
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