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Session 7 Track 1: eCTD 4.0 - Paving the Path for Streamlined Global Drug Submissions
Session Chair(s)
Daniel Offringa
Principal Consultant
eSub Solutions, United States
As eCTD 4.0 becomes a reality, the entire industry eagerly anticipates the advantages this standard can bring to streamline global regulatory submissions and facilitate a smooth transition towards data-driven processes. This session will carefully examine the implementation of eCTD 4.0 in regions that are newly adopting the standard. We will draw valuable insights from these experiences and shed light on the best practices, challenges and opportunities involved in embracing eCTD 4.0.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the current implementation status of eCTD 4.0 across different regions
- Discuss the impact of the shift to the new standard on current business processes
- Identify best practices for implementing eCTD 4.0 in their global submission process
Speaker(s)
eCTD 4.0 - Path to Streamline Global Submission
Wilesha Wright
MacroGenics, Inc., United States
Associate Director, Regulatory Operations
eCTD 4.0 - Path to Streamline Global Submission
Sadia Ahmed
IQVIA, United States
Associate Director Product Management, Regulatory Technology
Industry Readiness: Learnings from Pilot Submissions
Olga Alfieri, MBA, MSc, RAC
Eisai Pharmaceuticals, United States
Senior Director, Global Submission Management & Operations