Back to Agenda
On Demand 5 Track 4: Global eCTD Specifications
Session Chair(s)
Peter Terbeek, MBA
Senior Director, Regulatory Operations
United States
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.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the new uses of eCTD for Health Canada and how to submit them
- Identify and incorporate latest M1 components for EU, US, CA and CH
- Create compliant EAEU submissions and estimate the required effort
Speaker(s)
eCTD Module 1 Specifications Updates for AU, JO, EU, US, CH, and CA
Sujit Shetty, MBA, RAC
Quartesian, India
Manager - Regulatory Publishing
Everything Old is New Again – Health Canada CTAs in eCTD
Rob Labriola, MS
Garuda Therapeutics, United States
Exec. Director, Regulatory Operations
The Eurasian Economic Union Electronic Submission Format: It's not *not* an eCTD
Joel Finkle
Retired, United States
Industry Expert
Have an account?