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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 7 Track 1: eCTD 4.0 - Paving the Path for Streamlined Global Drug Submissions

Session Chair(s)

Daniel  Offringa

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


Wilesha  Wright

eCTD 4.0 - Path to Streamline Global Submission

Wilesha Wright

MacroGenics, Inc., United States

Associate Director, Regulatory Operations

Sadia  Ahmed

eCTD 4.0 - Path to Streamline Global Submission

Sadia Ahmed

IQVIA, United States

Associate Director Product Management, Regulatory Technology

Olga  Alfieri, MBA, MSc, RAC

Industry Readiness: Learnings from Pilot Submissions

Olga Alfieri, MBA, MSc, RAC

Eisai Pharmaceuticals, United States

Senior Director, Global Submission Management & Operations

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