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.
- EXTEDO company overview
- DMF Regulatory Timelines
- DMF Electronic Regulatory Process
- Conversion from Paper
- Regulatory Publishing
- Submission through the Electronic Submission Gateway
- eCTDmanager live demo
- Populating envelope elements
- Adding documents
- Creating hyperlinks easily
- Submission Life Cycle
- 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.