Training Course on Building the eCTD - Practical Solutions to Compile Electronic Submissions

Venue: Novotel Nice France Acropolis

Location: Nice, France

Event Date/Time: May 16, 2011 End Date/Time: May 17, 2011
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This course will offer insight into eCTD lifecycle management and global submission management practices combining hands on exercises with presentations on best practices and practical experience.

Key Topics

eCTD compilation
eCTD publishing
eCTD validation
eCTD lifecycle management
Compiling Study Tagging Files (STFs)
Regulatory strategy
Regional differences in eCTD requirements
Co-ordinating global eCTD submissions

Learning Objectives:

At the conclusion of this course participants should be able to:

Compile a technically validated eCTD for various regions
Maximise the reuse of compiled content
Understand eCTD publishing and technical validation
Understand the differences in the regional interpretations of electronic submissions
Consider the impact of various regional interpretations of eCTD Specifications and Guidelines on global submissions strategy

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