11.08.09 - 12.08.09
FORUM: The eCTD, 11-12 Aug 2009, Munich, Germany
Presentations on & practical computer workshop for dossier submission
Preparatory seminar
11 August 2009
- NeeS and eCTD - two competing standards?
- eCTD structure - XML backbone, EU envelope
- Lifecycle management
Main Seminar
12 August 2009
- eCTD implementation
- Computer workshop on the compilation - one computer for each participant!
- Efficient preparation for the validation phase
Speakers:
Andreas Suchanek, EXTEDO GmbH, Ottobrunn, Germany
Dr. Gerhard Neurauter, EXTEDO GmbH, Ottobrunn, Germany
Karl-Heinz Loebel, PharmaLex GmbH, Mannheim, Germany
Program