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:
(Conference organized by Concept Heidelberg)