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DIA-RSIDM

DIA-RSIDM

Past Event

Drug Information Association – Regulatory Submissions, Information, and Document Management Forum


Dedicated exhibit hours:

Monday – February 8th
11:00 – 11:30am EST
12:30 – 1:30pm EST
3:45 – 3:15pm EST  
Tuesday – February 9th
11:15 – 11:45am EST
1:00 – 1:30pm EST
2:45 – 3:15pm EST
4:30 – 5:30pm EST  
Wednesday – February 10th
11:15 – 11:45am EST
1:00 – 1:30pm EST
2:45 – 3:15pm EST  
Presentations
Live Q&A Session: Global eCTD Specifications
Rob Labriola, MS, Sr. Director of Regulatory Operations, Synchrogenix -- Peter Terbeek, MBA, Senior Director of Publishing and Submission, Astellas -- Joel Finkle, Associate Director of Regulatory Information Management, Beigene |
Visit virtual booth to learn more and to sign up for the live Q&A session.
On Demand 5 Track 4: Global eCTD Specifications
Rob Labriola, MS, Sr. Director of Regulatory Operations, Synchrogenix -- Peter Terbeek, MBA, Senior Director of Publishing and Submission, Astellas -- Joel Finkle, Associate Director of Regulatory Information Management, Beigene |
This session will cover significant eCTD specification changes in several prominent countries/agencies. Health Canada is accepting Clinical Trial Applications in eCTD format via the Electronic Submissions Gateway and has announced it will accept eCTD submissions for other trial-related activities as well. In Russia there is a new EA EU submission format called R.022 which certainly resembles the eCTD and the Mutual Recognition Procedure but has its own nuances. And there have been notable changes to Module 1 specifications for FDA, EMA, SwissMedic and Health Canada. This session will bring you up to speed on all of these specifications and ensure you can remain compliant. Visit virtual booth to watch the on demand recording.
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