Are you ready for eCTD-based DMFs? You only have two more months to be compliant!

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 workshop and eCTDmanager training courses, taking place in Shanghai from 23rd April – 27th April 2018.

 

eCTD Workshop – 23rd April 2018, 09:00 am – 05:00 pm

During the first day, 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.

 

eCTDmanager Training Courses

Throughout the remainder of the week our consultants will run detailed training classes covering EXTEDO’s eCTDmanager and the use of eCTD regulatory standards around the globe.

  • eCTDmanager Refresher Training – 24th April 2018, 09:00 am – 05:00 pm
  • eCTDmanager Basic Level Training – 24th – 25th April 2018, 09:00 am – 05:00 pm
  • eCTD in other regions – 26th April 2018, 09:00 am – 05:00 pm
  • eCTDmanager Add-Ons – 27th April 2018, 09:00 am – 05:00 pm

A full agenda of our training courses can be found here.

Register now and save 400 RMB per day!

 

Event Details and Registration


Date: 23rd April - 27th April

Time: 09.00 am – 05.00 pm

Venue:

Parkyard Hotel Shanghai
No. 699 Bibo Road, 201203 Pudong New Area
Shanghai
http://www.parkyardhotelshanghai.com/

Fees:

Workshop: The participation is free of charge.
Training Courses:

  • Early Bird: 3.900 RMB per day and person (available until 26th March) (excl. tax)
  • Regular Fee: 4.300 RMB per day and person (excl. tax)
  • Each Training course can be either taken individually or as a whole
Registration: 

If you are interested in participating the workshop or any of the offered training classes, please send an e-mail to request@china.extedo.cn

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! 

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