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Session 10 Track 4: Transformation in Submission Management: Current Activities and Future Trends
Session Chair(s)
Stacy Tegan
Program Director, Transcelerate Biopharma Inc., United States
The world of submission management is evolving. Beside specifications evolution and technology development, the approval prioritization during the pandemic in utilizing rolling submissions, opened the view for transformation beyond the normal evolution. This session will focus on exploring observed industry trends and the impact on submission content, processes, and technology.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand key industry trends pushing transformative change related to submission management
- Gain awareness to industry stakeholder experiences as it relates to the transition to eCTD 4.0 and international health authorities’ submission review collaboration
Speaker(s)
Teresa Martins
Senior Director, US Site Head Regulatory Submission Management, Bayer U.S. LLC, United States
Experience Gained from the eCTD 4.0 US FDA Pilot
Akira Yamaguchi, MBA
Chief Technical Officer, LORENZ Life Science Group, United States
A Conceptual Overview of Industry Trends and the Impact on Submission Content, Process, and Technology
Shannon Laforce, MBA
Executive Director, Transformation and Business Informatics, RMOD, HPFB, Health Canada, Canada
Cloud Based, Collaborative Review Across Multiple National Agencies: Pilot Learnings & Future Impact