eCTD & DMS Workshop (EXTEDO/ProductLife/NextDocs) Switzerland
The complete picture presented by strong partners! Two locations: Basel / Lausanne
EXTEDO invites you to a free of charge workshop in Switzerland:
Agenda eCTD & DMS Workshop - 24 March (Basel) and 25 March (Lausanne)
12:30 - 13:00 Registration
13:00 - 13:15 Opening and introduction
13:15 - 14:00 Information Management processes integration for Life Sciences – from a consultant’s perspective (Dr. Erick Gaussens, ProductLife)
- Document and Content Management
- Regulatory submissions and tracking
- Quality Systems
- Insourcing and outsourcing/ offshoring scenarios
14.00 - 14.15 EXTEDO - Your partner for all electronic Regulatory Affairs issues
- Short company presentation
- Overview about the product and service portfolio
14.15 - 15.15 Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Rainer Schwarz / Orang Gholikhani, NextDocs)
- Company and Strategy Overview
- Document Management System: Regulatory Submission, SOP, Clinical Trial
- Interoperability & Integration
- Quality Management System : CAPA, Deviation, Audit
15:15 - 15:45 Coffee Break
15:45 - 17:00 Why eCTD and Document Management System (DMS) belong together (Prof. Dr. Thomas Städter, EXTEDO)
Submission Management as a most complex ECM Process
- DMS & eSubmission Requirements
- Document- and Dossier Lifecycles
- How NextDocs and eCTDmanager work together
- Deployment Process
How to work with eCTDmanager – Live Presentation
- Setup an eCTD dossier
- Collaborative work on dossiers/submissions
- eSubmissions and Paper Publishing
17:00 - 17:30 Q&A
Event Information
Registration
The registration is free of charge. Please register online:
24 March, Basel: www.amiando.com/extedo01
25 March, Lausanne: www.amiando.com/extedo02
Date, Languages & Location
Wednesday, 24 March – Basel
Presentations will be in German and English
Hilton Basel Hotel
Aeschengraben 31
CH-4051 Basel
Tel. +41 61 275 6600
www.hilton.de/basel
Thursday, 25 March – Lausanne
Presentations will be in French and English
Hotel Alpha-Palmiers Lausanne
Rue du Petit-Chêne 34
CH-1003 Lausanne
Tel. +41 21 555 5999
www.fhotels.ch
Contact
If you have any questions regarding this event, please contact:
Thomas Kessler (Marketing Manager)
Tel. +49 89 189454-222