From 24 June 2021, two OPDP / Ad-Promo submission types to the US FDA have to be submitted in eCTD format, using the latest DTD 3.3.
These submissions are required if you want to promote prescription drugs in the US.
If you are not preparing your Ad-Promo submissions in eCTD format already, this webinar will help you to understand what should be done now.During the webinar, Susan Paisley will talk about the structure and requirements of OPDP / Ad-Promo submissions. She will give you an overview about lifecycle maintenance as well as what to consider from a business and regulatory point of view.
Following the theoretical part, Dominique Hetrick will give you a live demonstration how OPDP submissions are managed within eCTDmanager.
At the end of the webinar, the speakers will answer your questions in the Q&A session.
- EXTEDO corporate intro
- Update on OPDP submissions
- eCTDmanager live demonstration
- Q&A session
Time and Date
Wednesday, 12 May 2021, 09:00am EST (New York) | 02:00pm GMT (London) | 03:00pm CET (Berlin)