Novotel Barcelona City, Barcelona, Spain
Mar 8 2012 8:00AM - Mar 9 2012 4:00PM
During this interactive workshop participants will learn about the Electronic Common Technical Document
(eCTD), its components and history, preparing submission ready documents, as well as best practices for
changing your business processes in preparation for moving towards electronic submissions. Participants
will then apply this information and compile a two-sequence submission for a single country EU national
procedure using LORENZ DocuBridge®, as well as repurpose the EU compilation for Switzerland. Key Topics - eCTD components and history
- eCTD vs. non-eCTD electronic Submissions (NeeS)
- Creating submission ready documents
- Regional differences in eCTD requirements
- eCTD compilation
- eCTD publishing
- eCTD validation
- eCTD lifecycle management
- Regulatory strategy and best practices
- Co-ordinating global eCTD submissions
Learning Objectives:
At the conclusion of this course, participants should be able to:
- Demonstrate a general understanding of the eCTD
- Compile a technically validated eCTD for various regions
- Explain how to maximise the re-use of compiled content
- Describe the eCTD publishing and technical validation
- Explain the differences in the regional interpretation of electronic submissions
- Evaluate the impact of various regional interpretations of eCTD specifications and guidelines on global
- submissions strategy
Event Code:
12564
|
|