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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don’t miss the latest conversations in RIM, EDM, and ERS! Join your industry colleagues and regulatory thought leaders and register for the Regulatory Submissions, Information, and Document Management Forum.

Session 6 Track 4: Regional Adoption of eCTD, the Next Wave (China, Eurasia, Middle East)

Session Chair(s)

Michelle L. Charles, MPH

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


Adair  Turner, MSc, RAC

Implementation of eCTD in Eurasia and the Middle East

Adair Turner, MSc, RAC

Cencora Pharmalex, United States

Sr. Director, Head of Regulatory Affairs US

Jared  Lantzy, PMP

eCTD Adoption in China

Jared Lantzy, PMP

Booz Allen Hamilton, United States

Lead Associate

Dustin  Weisman

Planning for eCTD in China: Process and Technology Considerations

Dustin Weisman

Novartis, United States

Technical Design Expert

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