DIA Training Course on Building the eCTD: Practical Approaches to Compiling Electronic Submissions

Venue: Novotel Barcelona City

Location: Barcelona, Spain

Event Date/Time: Mar 08, 2012 End Date/Time: Mar 09, 2012
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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

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