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QDossier Presenting on Filing eCTD Submissions
Join us for this intensive one-day training course on filing eCTD submissions. This course will provide in-depth knowledge on components of eCTD and how to build a dossier right the first time using MS word templates. By getting insights from trainers who have vast experience in eCTD submissions, you will learn how to build, publish and deliver successful submissions across the EU and the US.
An interactive case study session will provide practical knowledge and explore the challenges during eCTD submissions.
Following topics will be covered in this training:
Introduction and overview of the eCTD
• The global regulatory framework
The benefits of using MS Word template
• Demonstration of template
What are the main components of the eCTD?
• XML backbone
Life cycle management for eCTD submission
• Granularity considerations
• Combining documents
• Use of operators
Review of eCTD validation criteria
• Considerations (inherit zoom, filenames, node extensions, etc)
• How to prepare for these (to prevent validation issues)
Practical experiences of submitting eCTDs
• Experiences submitting in EU
• Experiences submitting in the US
• Publish, compile, and submit an eCTD sequence
Considerations for outsourcing
• Why outsource eCTD vs in-house?
• How to select the right eCTD partner
• Best practices for an outsourcing process
Find out more information on the event here.
Marloes van der Geer