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QUMAS & EXTEO Present:
Why eCTD and Document Management Systems belong Together!

28 April 2010, Munich, Germany

Agenda

13:00 - 13:30 Registration & Coffee
13:30 - 13:45 Opening and introduction (All)
13:45 - 14:00 EXTEDO - Your partner for all electronic Regulatory Affairs issues (Gero Morres, EXTEDO - in German)
  • Short company presentation
  • Overview about the product and service portfolio
14:00 - 14:15 QUMAS - Company & Product overview (Steve Dawson, QUMAS - in English)
14:15 - 15:00 Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Cyril Walsh, QUMAS - in English)

  • Document lifecycle
  • Working with templates
  • Versioning of documents
  • Document workflows, Reviewing, Editing, Approving
  • Document Management System: Regulatory Submission, SOP, Clinical Trial
15:00 - 15:15 Coffee Break
15:15 - 15:45 Why eCTD and Document Management System (DMS) belong together (Prof. Dr. Thomas Städter, EXTEDO - in German)

  • Interoperability & Integration
  • Collaborative work on dossiers
  • Compliance aspects
15:45 - 16:30 How to work with eCTD - eCTDmanager presentation (Prof. Dr. Thomas Städter, EXTEDO - in German)

  • Setup an eCTD dossier - overview
  • eCTD and paper publishing
16:30 - 16:45 QUMAS Quality Management Solution (Managing Compliance requirements within the Quality department)

  • Quality Management System : CAPA, Deviation, Audit
16:45 - 17:15 Q&A

Download complete details & agenda in English

Download complete details & agenda in German

Registration Form

To begin registration, please fill out the information below and click "SUBMIT" when you have completed the form.

Yes, I will attend the QUMAS - EXTEDO, 'Why eCTD and Document Management Systems belong Together!' Why eCTD and Document Management Systems belong Together!' event at the FOM University of Applied Sciences, Munich at 1:00pm on Wednesday, April 28, 2010