eCTD on Twitter
- Malta: Requirements on Electronic submissions for New Applications within National and European procedures #ectd
http://bit.ly/9m1pQl2010/09/08 09:39 - Check out Reed Tech's LabelDataPlus super search tool for SPL, searching repository of of 27052 drug labels:
http://bit.ly/cYdc982010/09/07 12:03 - Highlights of IRISS Interoperability group’s July, August mtgs posted, incl some FDA news
http://bit.ly/bPEeEN & http://bit.ly/brD5OY #ectd2010/08/31 10:07
Search
Visit GlobalSubmit
The eCTD Company™
Archive for October, 2008
eCTD on the Agenda at Upcoming ICH Meeting
posted by Kathie Clark @ 9:17 AM
Friday, October 10, 2008
A public ICH meeting is planned for 14 November 2008 in Brussels, Belgium. See Brussels ICH Public Meeting, Nov. 14, 2008 for the details and agenda.
The agenda includes a session on standards development for the electronic exchange of information (chaired by Andrew Marr). That session will include, among other topics, an update on eCTD from Joe Cipollina.
(0 Comments)
An RPS2 Working Group meeting was held in Vancouver the week of September 15.
The working group discussed a number of business scenarios including:
- Two Way Communication – Pre-Submission Correspondence
- Submission Activities – Request Submission Number
- Submission Activities – Meeting Request and Responses
- Notification of Decision or Action
- Request/Response for Additional information during a review cycle
- Follow-up/Postmarket Correspondence
- Referencing – Permit Use of Master file, Master Access File or Third Party Documentation
- Referencing – Comparison Information
- Referencing – Reference Information sent to an external party
- Referencing - Paper Submission
- Labeling Negotiations
- Interim Actions (i.e., complete response letter, tentative approval, non-final actions, hold decisions, etc.)
- Administrative Actions – Technical/Validation Reports/ErrorsSome of these scenarios were removed from requirements iteration #1 or merged with other scenarios.