In September, the CDE issued the draft of the electronic Common Technical Document (eCTD) submission guidelines, verification standards, the supporting eCTD technical specifications and other documents for a second round of public consultation.
It is very likely that the final validation criteria for eCTD in China will be published soon.
eCTD has already been implemented in many countries and regions such as the European Union, Switzerland, USA, Canada, the Middle East and South Africa for serveral years.
EXTEDO supported many regulatory agencies introducing eCTD in their region and our software solutions are compliant with all eCTD specifications globally. The Chinese eCTD standard will be included soon as well.
EXTEDO and NeoTrident invite you to our complimentary webinar about the basics of eCTD submissions and China-specific details. Regulatory Affairs professionals, who would like to get an overview about the eCTD submission standard and see, how an eCTD submission can easily be created and validated using a submission management software, will particularly benefit from this webinar.
During the webinar, Michael Faust will give you an eCTDmanager live demonstration, EXTEDO’s submission management solution for global eCTD and other submission format compliance.
Additionally, we will answer questions like:
- What is eCTD?
- What are the benefits of eCTD?
- How will the Chinese eCTD specification look like?
What is necessary to create and validate an eCTD submission and how is this done?
1. EXTEDO company overview (Thomas Kessler, EXTEDO)
2. NeoTrident company overview (Tao Shi, NeoTrident)
3. Introduction to eCTD Submissions in China (Michael Faust, EXTEDO)
- Introduction into eCTD and benefits of the standard
- Timelines in China
- The Chinese eCTD standard in detail
- Workflow of an eCTD submission
- Validation criteria of an Chinese eCTD dossier
4. Live Demos: Creation and Validation of an eCTD Dossier (Michael Faust, EXTEDO)
- How an eCTD Submission is easily created and validated using eCTDmanager
- Validation of an Chinese eCTD submission using EURSvalidator
5. Questions & Answers
Event Details and Registration
Date: Wednesday, 15 April 2020
08:00h CEST (Berlin, Paris)
11:30h IST (Mumbai, New Delhi)
14:00h CST (Shanghai, Bejing)
Duration: 60 Minutes
Language: English with some Chinese translations
Register free of charge: https://register.gotowebinar.com/register/6523041154328429837