Half-Day Complimentary Workshop
Thursday, November 10th , 2011
13:30 PM - 17:30 PM
FOM University of Applied Sciences
Room A03
Arnulfstrasse 30 - about 100m from “Hauptbahnhof” / Main Station
80335
Munich
NextDocs and EXTEDO invite you to a half-day workshop covering the hot topics of eCTD / electronic submissions and document management.
Whether you are looking for a software solution that helps you manage, view and publish your regulatory process or planning to outsource your regulatory submissions, this workshop will provide valuable insight.
By attending you will:
- Hear about a successful project where a complete integration between eDMS and eCTD has been realized by sanofi pasteur MSD
- Learn how to work with eCTD
- Understand why eCTD and Document Management System (DMS) belong together
- Gain insight into Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences
Experts from the leading service and solution providers will share their experience through presentations and live demos. See first-hand how easily documents and submissions can be managed using EXTEDO eCTDmanager integrated with the SharePoint-based Document Management System from NextDocs.
Experts from the leading service and solution providers will share their experience through presentations and live demos.
Session Agenda:
| Time |
Topic |
13:30 – 14:00 |
Registration |
14:00 – 14:15 |
Opening Remarks and Introduction |
14:15 – 15:15 |
Real example of a complete Information Management Process Integration for submission (Nathalie Kalita ,Head of Regulatory Operations and Compliance, SPMSD)
- Conception and design
- Migration, Implementation
- Lesson learned
|
| 15:15 – 15:30 |
Coffee Break |
15:30 – 15:45 |
Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Romuald Brown, NextDocs)
- Company and Strategy Overview
- Document & Quality Management System
- Regulatory Submission, SOP, Clinical Trial
- Interoperability & Integration
|
15:45 - 16:00 |
EXTEDO - Your partner for all electronic Regulatory Affairs issues (Günter Rodenkirchen, EXTEDO)
- Overview about the product and service portfolio
|
16:00 - 17:00 |
Why eCTD and Document Management System (DMS) belong together (Prof. Dr. Thomas Städter, EXTEDO and Christophe Benninghoff, NextDocs)
Submission Management as a most complex ECM Process
- DMS & eSubmission Requirements
- Document- and Dossier Lifecycles
- How NextDocs and EXTEDO eCTDmanager work together
- Deployment Process
|
17:00 - 17:30 |
|
|
|
Thursday, November 10th , 2011
13:30 PM - 17:30 PM
Venue:
FOM University of Applied Sciences, Room A03
Arnulfstrasse 30 - about 100m from “Hauptbahnhof” / Main Station
80335 Munich
Register:
For more information email Margaret Mottolo at mmottolo@nextdocs.com