Integrated Regulatory Compliance Management: From Concept to Real World - How eCTD and DMS work together: Complimentary half day workshop in Munich

NextDocs and EXTEDO invite you to a half-day workshop covering the hot topics of eCTD / electronic submissions and document management.

By attending you will:

Hear about a successful project where a complete integration between eDMS and eCTD has been realized by Sanofi Pasteur MSD : Case Study
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.

Speakers:

Nathalie Kalita, Head of Regulatory Operations and Compliance, Sanofi Pasteur MSD
Günter Rodenkirchen, Account Manager, EXTEDO GmbH
Prof. Dr. Thomas Städter, Managing Consultant, EXTEDO GmbH
Christophe Benninghoff, Pre-Sales Consultant, NextDocs Corporation
Romuald Brown, Business Manager, NextDocs Corporation

Session Agenda:

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
Change Management and European Deployment
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 Q&A

Who Will Benefit?

Global project managers
Regulatory, medical, and technical writers
Biostatistics and data management Information technology
Clinical research & development/Clinical supplies
eClinical, Electronic regulatory submissions/Document management

Date & Venue:

Thursday, November 10th, 2011
13:30h - 17:30h

FOM University of Applied Sciences, Room A03
Arnulfstrasse 30 - about 100m from “Hauptbahnhof” / Main Station
80335 Munich

Email Thomas Kessler at kessler@extedo.com for more information

Registration:

The registration is free of charge, please register online with the form below until November 05.
Event date: 10/11/11 to
Location: Munich, Germany

To find more information please click here: Integrated Regulatory Compliance Management: From Concept to Real World - How eCTD and DMS work together: Complimentary half day workshop in Munich