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Session 6 Track 4: Evolution from the “Global Dossier Concept” to Joint Dossier Co-Creation
Session Chair(s)
Stacy Tegan
Program Director, Transcelerate Biopharma Inc., United States
There is an emerging need to accommodate global submission support for international countries covering both eCTD and non-eCTD requirements. This session features practical case study experience implementing the “Global Dossier Concept”: a global collaborative operational model pilot to enable global co-creation methodology and successful same day filings across multiple countries. Hear perspectives from sponsor experts in both US and China Regulatory Submission Management, as well as from the application vendor partner.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify the expanded scope for adequate coverage of countries’ eCTD needs and for international country dossier compilation beyond eCTD
- Examine ways for efficiently assigning responsibilities globally for an expanded dossier concept intended for universal same day filings
- Evaluate the overall specific country requirements and how new technologies/vendors can accommodate these different needs
Speaker(s)
Evolving the “Global Dossier Concept”
Senior Director, US Site Head Regulatory Submission Management, Bayer U.S. LLC, United States
The Co-Compilation Journey
Associate Director, Regulatory Submission Management, Bayer Healthcare Company Limited, China
Challenges to Achieve Success with the Global Dossier Concept
Chief Technical Officer, LORENZ Life Science Group, United States
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