The US FDA allows applicants to submit a common change, for many submissions, within one main submission. Submission Grouping has high business value, saving applicants time and effort. However, experience shows that the compilation and control carry risks of errors.
EXTEDO invites you to its complimentary webinar "US FDA Grouped Submissions - Agency Requirements and Best Practices for Submission Management".
During the webinar, Ted Hanebach will talk about general information, limitations of use and technical aspects of submission grouping. He 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, Michael Nemec will give you an eCTDmanager live demonstration.
After the presentation the speakers will answer your questions in the Q&A session.
Event Details and Registration
Date: Wednesday, 18 September 2019
- 10:00 am EDT (New York, Philadelphia)
- 03:00 pm BST (London, Lisbon)
- 16:00 h CEST (Madrid, Berlin)
Duration: 60 Minutes
Participation is free of charge.