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On Demand 5 Track 4: Global eCTD Specifications
Session Chair(s)
Peter Terbeek, MBA
Executive Director, Regulatory Data and Document Operations
Astellas Pharmaceuticals, 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