In this conference, Dr. Hiltrud Horn will give detailed insight into typical CMC-issues that a CMC Manager or CMC-team leader should know. Apart from EU she will guide you through the registration process of drugs in the US (FDA). She will share her experience in a workshop with case studies from current CMC-projects. Learn about CMC-strategies and take the chance to benefit from the exercises for your daily work. Furthermore detailed insight will be provided on dealing with variation and changes in EU and US and about the challenges in a global environment. You will understand the agencies and their approach in dealing with your CMC-changes.

For more information please visit the following website:

(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