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.