Dr. Hiltrud Horn will give various presentations on the challenges and practical implications of starting materials (API). She will also explain the differences in CEPs, ASMFs and DMFs. Furthermore, you learn how to write the CMC-dossier efficiently and which data might be critical. She will show you practical examples to encourage you in your decision-making process and train you how to avoid pitfalls. Furthermore you will learn when you should consider meetings with authorities and how to prepare for those. 

For more information please visit the following website:
https://www.forum-institut.de/seminar/2011275-apis-in-regulatory-affairs

(Conference organized by FORUM Institut)

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