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.

Due to the COVID-19 pandemic this course is now offered as live online training.

For more information please visit the following website:

https://www.gmp-compliance.org/training/gmp-course-conference/live-online-training-drug-master-file-procedures-in-the-eu-the-us-and-japan

(Conference organized by Concept Heidelberg)

HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de