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Session 7, Track A: The Future of Regulatory Submissions: CTD, eCTD, and Cloud-based Systems
Session Chair(s)
Flavia Firmino Ribeiro, PharmD
Director Reg Global CMC
Pfizer, Brazil
Jorge Azar
Senior Area Regulatory Director for Latin America
AstraZeneca, United States
In this session, speakers will discuss the future vision and potential enhancements of CTD and eCTD for regulatory submissions. The session will explore advancements in technology and best practices that can further improve the effectiveness and acceptance of these formats. Participants will also have the opportunity to recognize the importance of digital ways of work including eCTD implementation, without ignoring the different challenges and numerous advantages.
Learning Objective : - Recognize eCTD's foundational significance and assess its adaptability and inherent limitations amidst rapid technological advancements in the cloud era
- Identify how cloud platforms can address eCTD's limitations, fostering enhanced information
- Evaluate the criticality of adopting emerging data standards and strategies for more efficient management of regulatory submissions
Speaker(s)
Cloud-based Systems as an Enabler or Regulatory Efficiency
Cesar Vinces
Accumulus Synergy, United States
EU Interim and International Policy Lead
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