The US FDA just announced, that from March 2022 on, all submissions have to be submitted using the DTD version 3.3. For OPDP / Ad-Promo submissions, DTD 3.3 will be mandatory by the end of this month already.
If you have not switched to DTD 3.3 so far, this webinar will help you to understand what you need to do now.
After a short introduction to EXTEDO, Susan Paisley will talk about the history of the DTD versions and the envelopes. She will explain what is new in 3.3 and what are the differences between both versions.
Following the theoretical part, Dominique Hetrick will show how an upgrade from 2.01 to 3.3. is done using eCTDmanager. She will also highlight the regulatory activities view functionality.
At the end of the webinar, the speakers will answer your questions in the Q&A session.
- EXTEDO corporate intro
- DTD History
- Review of both 2.01 and 3.3 envelopes
- Primary new 3.3 Envelope Areas
- Major differences between the two DTDs
- Contact information
- Submission Type and Sub-Type
- Submission ID and Submission Number
- M1 Section differences between 2.01 and 3.3
- All M1 section changes
- Live demo: Upgrade from DTD 2.01 to 3.3 using EXTEDO's eCTDmanager
- Q&A session
Time and Date
Wednesday, 16 June 2021, 07:00am PDT (Los Angeles) | 10:00am EST (New York) | 03:00pm GMT (London) | 04:00pm CET (Berlin)