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Session 7, Track A: The Future of Regulatory Submissions: CTD, eCTD, and Cloud-based Systems
Session Chair(s)
Flavia Firmino, PHARMD
Regulatory Policy Lead - Latin America, Eli Lilly and Company, 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)
Leonardo Santos, PHD
Advisor of the General Office of Medicines, ANVISA, Brazil
Anvisa's Expectations about the eCTD Implementation
Christelna Reynecke, MBA, RPH
Chief Operating Officer, South African Health Products Regulatory Authority (SAHPRA), South Africa
SAHPRA’s eCTD Journey
Cesar Vinces
Advisor, Regulatory Innovation, Nuvara, United States
The Future of Regulatory Submissions: Dossiers in the Cloud
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