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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 ·
Elektronisches Zulassungsdossier · Dossiererstellung