Einsatz eines Dossier-Management-Systems in der Arzneimittelindustrie
Auswahl, Einführung und praktische Erfahrungen
Dr. Alexander Kainz und Sven Harmsen
Fujisawa GmbH, München
Use of a Dossier Management System in the Pharmaceutical Industry / Selection, implementation and experiences from use
This paper describes the experience of Fujisawa GmbH, Munich (Germany), prior and following the installation of an electronic publishing system (dossier management system). It states reasons for investing into such a publishing system. The evaluation criteria and the implementation plan for such a system are examined, hurdles that had to be overcome during the first electronic compilation of a Marketing Authorisation Application are described. The authors discuss the challenges and limits of being compliant with the eCTD guideline and inform about the lessons learned.
Key words eCTD (Electronic Common Technical Document) · Elektronische Einreichung · Zulassungsdokumentation ·
pharmind 2003, Nr. 05a, Seite 511