Introduction and Best Practices about Electronic Submission in eCTD Format

EXTEDO and its partner NeoTrident are delighted to invite you to a day dedicated to networking, information sharing and best practices discussions focusing on electronic submission management.

The event “Introduction and Best Practices about Electronic Submission in eCTD Format” will take place at the China Hall of Science and Technology in Beijing on Thursday, 01st December from 9 am to 5 pm.

During the workshop, our team of experts will cover a wide range of topics including the introduction of eCTD, eCTD lifecycle management and real-life case scenarios.

Speakers

  • Martin Schmid, Managing Director, EXTEDO
  • Silke Nolkemper, Senior Business Consultant, EXTEDO
  • Stefan Horneborg, Channel Sales Consultant, EXTEDO

 

Agenda

9.00-9.30

Case Study Presentation (Chinese Company)

9.30-10.30

Introduction of eCTD

·         CTD vs. eCTD:differenctes between paper dossiers and electronic dossiers

·         General structure of an eCTD

·         Recommendation for industries / applicants

10.30-11.00

Coffee break

11.00-12.30

Details of the eCTD structure

·         Files and folders

·         Meta data

·         Bookmarks and Hyperlinks

·         XML-backbone, Envelope

·         Lifecycle attributes experience in EU in eCTD: how can several strengths and dosage forms be handled in one eCTD dossier ( handling of specific sections)

12.30-13.30

Lunch break

13.30-15.00

eCTD Lifecycle Management

·         Submission lifecycle

·         Document lifecycle

·         Specifications: EU, US, other regions

·         Special formats: ASMF, DMF

·         Time of eCTD preparation and format to be used

 

15.00-15.30

Coffee break

15.30-16.30

eCTD Best Practices

·         Do & Don´t

·         The most common validation issues and how to solve them

16.30-17.00

Questions & Answers

 

Venue

 

China Hall of Science and Technology

No. 3 Fu Xing Men

Hai Dian Disctrict

100863 Beijing

 

Register now:

English: Stefan Horneborg, horneborg@extedo.com

English or Chinese: market@neotrident.com

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