14th DIA Conference on European Electronic Document Management

Whereas eSubmission relates to submission teams within a pharmaceutical industry, it actually impacts all contributors to regulatory dossiers. It goes beyond format; such as indexing of dossiers, applicants, products, submissions and documents. Properly and consistently defined metadata definitions offer contributors to retrieve information from an electronic repository. Subsequently, information can be shown in context of a particular product in a particular country or in any other context. One might view the content; another might view a dashboard of what was submitted where and others might use the same information to analyse differences across dossiers. This session teaches us on where we are concerning eSubmission in Switzerland; where we might improve consistency and taxonomy in general and what to expect from eCTD v4.0.