From May 5, 2017, 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: Challenges to Overcome with the eCTD Format".
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
- Types of DMF
- DMF and eCTD
- Switch from paper to eCTD
- Live demo of example DMF eCTD creation
- Q&A session
Event Details and Registration
Date: Tuesday, 31 January 2017
- 10:00 am EST (New York, Philadelphia)
- 03:00 pm GMT (Lisbon, London)
- 16:00 h CET (Madrid, Berlin)