You're correct that it requires a third-party tool or service to create the SPL. CoreDossier/Insight Publisher doesn't do this, it only passes the file...
This is just a 2 or 3 line pre output script insert, why make it complicated. Sent via BlackBerry by AT&T ... From: "Dan" <dgower2@...> Date: Thu, 31...
panoramak, Could you please expound on this. It sounds like you're implying that third party tools are not necessary. Thanks, Dan ... complicated. ... Files;...
Due to growth and expansion we are tasked to fill many Regulatory Affairs Positions in varies locations; IL, NJ, FL and RTP (NC). Below is a brief summary of...
Does anyone have any links to useful resources regarding lifecycle management and operational attributes or case studies for the development of strategic plans...
Enter your vote today! A new poll has been created for the CoreDossier group: Is this user forum still relevant? I set this forum up 10 years ago when there...
CoreDossier@yahoogrou...
Jun 18, 2008 10:36 pm
812
Let it die Jeff Wilson, Principal Consultant Submission Consulting Group 2415 Beryl St San Diego, CA 92109 Jeff@... 858-354-3300 voice ...
Change it to eCTD Express and eCTD forum! Kelly M. Vlasak, MLT Regulatory Publisher IV Global Submissions Operations GPRA,Dept.PD85 Abbott Laboratories 200...
I agree that we should change it to an eCTD forum. Charnelle Ross Regulatory Systems Associate Solvay Pharmaceuticals, Inc 770-578-2056 ... Abbott ... and is ...
With the paper requirements for eCTD in Europe, the FDA extending waivers to accept hybrid electronic INDs and NDAs, and the recent EMEA guidances for NeeS...
I agree with Antoinette. Although, we (my company) are gradually moving to the eCTD for NEW Drugs and Biologic applications in the US, EU, parts of A-PAC. We...
You can remove me from the list, as I no longer support CofreDossier.Regards, Mark Baldus (858)874-5655 Home (858)874-5955 Fax (858)638-3854 Work To:...
I would like to second Robert's suggestion to expand the focus of the group. As the vendors are becoming more diverse, the chance to share information with...
Hey everyone! The recruiter that contacted me with this was absolutely the most personable and kind recruiter I've ever spoken with. Although I'd love to...
Dear All, I hope this finds you all well and successful!! I have posted a full time position for a Regulatory Affairs Sr. Associate position reporting to...
Hello All, i am very interested in solving some of the few issues that I see with eCTD, in particular the lifecycle management of approved products. Here is...
The following CoreDossier poll is now closed. Here are the final results: POLL QUESTION: Is this user forum still relevant? I set this forum up 10 years ago ...
CoreDossier@yahoogrou...
Aug 1, 2008 7:43 am
824
I will be out of the office from 07/25/2008 until 08/04/2008. I will be on vacation from 7/28/2008 thru 8/1/2008. If you need assistance with the Los Angeles...
I will be out of the office starting 18/07/2008 and will not return until 04/08/2008. I will reply to your message as soon as possible after I return. If...
Glad the CoreDossier Yahoo group is still alive and functioning. :-) It was suggested by some that we could use this group for eCTD questions. I have 2...
Hi Jean, I have some experience with your first question about 16.3. First, a lot depends on what your eCTD tool will let you do. Some, like Submission...
Jean: I hope you're doing well. We used to also include a list of linked CRFs in the old eSub days, but with the eCTD, we don't do this any longer. The Agency...
The results of the last poll indicate that 66% of those responding said that this group was still useful. Some respondents suggested that we broaden the scope...
Agree, we still used Coredossier, but are also using eCTDXpress. Kelly M. Vlasak, MLT Regulatory Publisher IV Global Submissions Operations GPRA,Dept.PD85 ...
I think it would be helpful to have it widened to the larger scope of eCTD. Kathryn ________________________________ From: CoreDossier@yahoogroups.com...
I will be out of the office starting 08/29/2008 and will not return until 09/03/2008. If you need to contact someone immediately, call Ernest Andalcio 7-3235,...
Hi Lance, Agree with the direction you are proposing. Antoinette ... Yours truly, Antoinette Azevedo President & CEO e-SubmissionsSolutions.com - "Publishing...
Enter your vote today! A new poll has been created for the CoreDossier group: How do you archive your electroinc submissions? (Select as many as applicable) o...
