In this conference you will get to know the relevant aspects regarding nitrosamines in drug substances and drug products. Dr. Hiltrud Horn will update you on latest requirements for EU and US and discuss what needs to be considered for API and drug product manufacturers including biologics. Specific aspects of packaging material will also be addressed. She will inform you about latest EU and US-implementation timelines for nitrosamines. In addition, a practical example of risk assessment is presented.

For more information please visit the following website:

(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