ARCS & EXTEDO: Introduction and Best Practices for Electronic Submissions in eCTD Format

This workshop will provide an overview of the history of eCTD, i.e. why we have the standard, the eCTD structure and life cycle management. Participants will look at file and folder requirements, metadata and hyperlinks. Furthermore, we will dive into the details of electronic lifecycle, eCTD validation and regional differences, e.g. EU and AU. Active substance and drug master file (ASMF & DMF) submissions in different regions will also be discussed. Afterwards we will demonstrate how to create an eCTD in a publishing tool, how to validate and will have time for a question and answer session.

Agenda:

eCTD structure and life cycle management

  • CTD vs. eCTD: differences between paper dossiers and electronic dossiers
  • General structure of an eCTD
  • Files and folders
  • Meta data
  • Bookmarks and Hyperlinks
  • XML-backbone, Envelope
  • Lifecycle Attributes Experience in e-CTD: how can several strengths and dosage forms be handled in one eCTD dossier (handling of specific sections)
  • Submission Lifecycle, e.g. Variations, line Extensions
  • Document Lifecycle (add/replace/delete/append documents)

eCTD Regional Differences

  • Best Practice
  • EU M1 and ASMF as special structure
  • Differences in the AU eCTD
  • US M1 and US DMF
  • Document requirements for US
  • ESG
  • Publishing Services

Creation and validation of an eCTD

Question and answer session

 

Workshop fees (incl. GST):

Early bird - until 07 AugARCS members - $550- Discount if also attending the ARCS Annual Conference - $440Non-members - $800- Discount if also attending the ARCS Annual Conference - $640Standard - from 08 AugARCS members - $685- Discount if also attending the ARCS Annual Conference - $550Non-members - $995- Discount if also attending the ARCS Annual Conference - $800

Click here to view terms and conditions

Event Details

  •  Where? Royal Randwick Racecourse, Randwick NSW
  •  Event Date:  21 August, NSW
  •  Registration Close Date: 14th Aug 17 11:59 PM
  •  Available Places: 40

Registration

https://www.arcs.com.au/events/event/ARCS-eCTD-workshop 

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