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eSUBMISSION
Session Chair(s)
Hans van Bruggen, MSc
CSO
Qdossier, a Celegence Company, Netherlands
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.
Speaker(s)
A Decade of eCTD- time to rejuvenate
Michiel Stam
Qdossier - A Celegence Company, United Kingdom
Director Regulatory Information Management
RPS/eCTD v4.0 topic
Joerg Schnitzler, PharmD, MSc, RPh
Boehringer Ingelheim Pharma GmbH & Co KG, Germany
Head of Global Regulatory Operations
Swissmedic Update
Janine Weix
Swissmedic, Switzerland
Head of Unit 1, Dep. Operational Support Services
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