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Session 6 Track 4: Regional Adoption of eCTD, the Next Wave (China, Eurasia, Middle East)
Session Chair(s)
Michelle L. Charles, MPH
Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States
This session will present a “case study” on adopting eCTD in China from both a process and technical perspective. The first presentation will focus on planning for eCTD submissions in China with a focus on the process and technical considerations Sponsors need to account for. This presentation will be followed by a session that will focus on how eCTD submissions in China will be validated and reviewed. The final presentation will focus on additional regions including Eurasia and the Middle East and planning, process and technical considerations for these regions.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify how submissions to China’s CDE will be validated and reviewed
- Identify changes in regulatory operations business processes for compiling Chinese eCTD submissions
- Implementation of eCTD in Eurasia and the Middle East
Speaker(s)
Implementation of eCTD in Eurasia and the Middle East
Adair Turner, MSc, RAC
Cencora Pharmalex, United States
Sr. Director, Head of Regulatory Affairs US
eCTD Adoption in China
Jared Lantzy, PMP
Booz Allen Hamilton, United States
Lead Associate
Planning for eCTD in China: Process and Technology Considerations
Dustin Weisman
Novartis, United States
Technical Design Expert
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