Complimentary Webinar: US DMF for FDA: Only Three More Months Until eCTD Becomes Mandatory!

From May 2018, all new Drug Master Files (DMFs) submitted to the US FDA, as well as any additional submissions relating to existing DMFs, must be submitted in eCTD format.
EXTEDO would like to invite you to join its complimentary webinar "US DMF for FDA: Only Three More Months Until eCTD Becomes Mandatory".

The webinar provides a unique opportunity for you to learn more about the upcoming regulation, the changes being made, as well as unique insights to overcoming the challenges involved. 

Following the presentation the speakers will answer your questions in the Q&A session.

Agenda
  1. EXTEDO company overview
  2. DMF Regulatory Timelines
  3. DMF Electronic Regulatory Process
    • Conversion from Paper
    • Regulatory Publishing
    • Submission through the Electronic Submission Gateway
  4. eCTDmanager live demo
    • ​​​​​​​Populating envelope elements
    • Adding documents
    • Creating hyperlinks easily
    • ​​​​​​​Submission Life Cycle
  5. Q&A session
Event Details and Registration 

Date: Wednesday, 14 February 2018

10:00 am EST (New York, Philadelphia)
03:00 pm GMT (London, Lisbon)
16:00 h    CET (Madrid, Berlin)

Duration: 60 minutes

Participation is free of charge. 

Registration: 

https://attendee.gotowebinar.com/register/5694989034267250433

 

 

EXTEDO is committed to follow the highest standards on Data Protection.

With a click on the button you allow EXTEDO to improve the user experience of this website. 
EXTEDO uses cookies for technical, performance and marketing reasons.
You can change your decision at any time.