Privatsphäre-Einstellungen

Vorteile elektronischer Dossier-Management-Systeme bei der Arzneimittelzulassung

Dargestellt am Beispiel eines europäischen zentralen Zulassungsverfahrens

Dr. Dietmar Böcker

Bayer AG, Wuppertal

Benefits of Electronic Dossier Management Systems in the Drug Marketing Authorisation Process / Exemplified with a procedure according to the European centralised authorisation process

Electronic dossier management systems are used in a late phase of product development. Therefore, it is essential that processes for issuing relevant documents for regulatory submissions are established in earlier phases of product development to generate documents and files in a suitable quality. In the light of the future standard concerning the electronic common technical document (eCTD) the purpose of this practice report is to give an insight especially into the prerequisites and the workflow of the electronic compilation of a submission dossier for a European centralised procedure. Consecutively, it is described which considerations have been conducted for the determination of the dossier format, which strategy was taken as a basis for the compilation of individual documents; how the content of the dossier was cross linked with the help of bookmarks and hyperlinks and which benefit the regulatory authorities took from this dossier. A further focus is the discussion of document templates and the pitfalls of the pdf-format. The conclusion is drawn that suitable standards and modern, flexible dossier management systems are a crucial factor to increase the benefit and the general acceptance of electronic regulatory dossiers.

Key words Dossier-Management-System, elektronisches eCTD · Elektronische Einreichung · Formatvorlagen · Kompilierung · PDF · Verlinkungsstrategie