The electronic Common Technical Document (eCTD) standard is being used increasingly in pharmaceutical environments around the globe.
From 5th May 2018, all Drug Master File (DMF) submissions will need to be filed electronically with the US FDA in eCTD format, or they will be rejected. This change will increase efficiencies throughout the DMF creation and review process, but is your company ready to comply?
To help you prepare for the new regulation and how to navigate the transition, EXTEDO and NeoTrident would like to invite you to their eCTD workshop taking place in Shanghai on 23rd April 2018.
During the workshop we will explore the eCTD standard, discuss the changes to the DMF filing process, and provide you with a step-by-step approach to ensure that you remain compliant once the change takes effect.
The participation for this workshop is free of charge.
- eCTD in China
- EXTEDO Service Partners in China
- EXTEDO Technology Partners in China
- Product Presentations
- Presenting solutions for API manufacturers
- Active Substance Master File in Europe
- Drug Master File in US
- ASMF / DMF as eCTD
- Customer Case Study
- A quick walk through eCTDmanager: creating, exporting and validating a DMF sequence for US FDA
Event Details and Registration
Date: 23rd April
Time: 09.00 am – 05.00 pm
Parkyard Hotel Shanghai
No. 699 Bibo Road, 201203 Pudong New Area
If you are interested in participating the workshop or any of the offered training classes, please send an e-mail to email@example.com
Places at our free workshop and the training courses are limited, so register before it's too late to ensure that you don't miss your spot!