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Session 9, Track 2: Optimizing Marketing Application Timelines: Insights and Strategies for Transitioning to eCTD 4.0
Session Chair(s)
Lindsay Fitzgerald
Delivery Manager, Astrix, United States
This session will explore the transition to eCTD 4.0 and its implications for marketing timelines. By examining the objectives of eCTD 4.0 and the challenges it presents for Regulatory Agencies and Industry, attendees will understand the importance of collaboration and be better equipped for its implementation. This session will help promote collaboration between industry and Health Authorities to streamline the transition to eCTD 4.0 and fully leverage its benefits.
eCTD 4.0 – THE Ambitious Attempt to Pull Together - Anjana Pindoria, EXTEDO GmbH
The Journey to eCTD 4.0: Test Driven Insights and Recommendations - Ankita Sunilkumar, Otsuka Pharmaceutical Development and Commercialization, Inc
Avoiding Common Roadblocks to Marketing Application Timelines - Allison Steffen, WAYS Pharmaceutical Services
Learning Objective : - Understand the evolution and objectives of eCTD 4.0, identify regional challenges and divergences and evaluate the Impact of new submission formats and data standards
- Recognize the need for strong collaboration among Industry, Vendors, and Health Authorities for the global implementation of eCTD 4.0
- Avoid common roadblocks and identify best practices to streamline the submission review process and help prepare for eCTD 4.0
Speaker(s)
Anjana Pindoria
Director Product Strategy, EXTEDO GmbH, Germany
eCTD 4.0 – THE Ambitious Attempt to Pull Together
Ankita Sunilkumar, MS, RPh
Senior Manager, Otsuka Pharmaceutical Development & Commercialization, Inc., United States
The Journey to eCTD 4.0: Test Driven Insights and Recommendations
Allison Steffen
Submissions Lead, Regulatory Operations, WAYS Pharmaceutical Services, United States
Avoiding Common Roadblocks to Marketing Application Timelines
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