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Session 8, Track 1: Preparing for and Implementing eCTD 4.0 Implementation: Strategies, Challenges, and Lessons Learned
Session Chair(s)
Shenqi (Handsome) Ji
Publishing Regional Director, Asia, Global Regulatory & International Operations, Pfizer, China
This session provides a comprehensive exploration of the global implementation landscape and practical strategies for eCTD 4.0. We will begin by delving into the European Medicines Agency's (EMA) eCTD v4.0 journey, sharing valuable insights from its pilot program and exploring its connections to future global standards. Next, based on the first-hand experiences from technical pilots with the US FDA and Japan's PMDA, we will analyze key implementation challenges from an industry perspective, such as metadata harmonization, managing multiple versions, and tool interoperability. Finally, the session will leverage lessons learned from the transition to eCTD 3.3 to offer specific preparation strategies and best practices for submitters, including those in advertising and promotion. By integrating perspectives from Europe, North America, and Asia, this session aims to provide a holistic roadmap and practical guide for a successful transition to eCTD 4.0.
The EMA eCTD v4 Journey and the Impact on the Life Sciences Landscape
Anjana Pindoria, EXTEDO GmbH
eCTD 4.0: How to Prepare and Lessons Learned from eCTD 3.3 Transition
Calyn Stanfill, Gilead Sciences, Inc.
eCTD 4.0: How to Prepare and Lessons Learned from eCTD 3.2.2 Transition
Jason Cober, ProPharma Group
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the EMA's eCTD v4.0 implementation path and its impact on the life sciences landscape
- Analyze key challenges and practical experiences from the FDA and PMDA technical pilots
- Learn preparation strategies and best practices derived from previous eCTD v4.0 transitions
Speaker(s)
The EMA eCTD v4 Journey and the Impact on the Life Sciences Landscape
Anjana Pindoria
Director Product Strategy, EXTEDO GmbH, Germany
eCTD 4.0 Analysis Based on First Experience with US FDA and JAPAN; Based on RAPS Publication
Calyn Stanfill
Associate Director, Regulatory Publishing, Gilead Sciences, Inc., United States
eCTD 4.0: How to Prepare and Lessons Learned from eCTD 3.2.2 Transition
Jason Cober, MPA
Senior Consultant, Regulatory Affairs, Ad Promo & Digital, Compliance Forward, United States
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