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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 3: The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework

Session Chair(s)

Jared  Lantzy, PMP

Jared Lantzy, PMP

Executive Director, Global Regulatory Operations

Novavax, Inc., United States

Innovative advances for automating and exchanging submission data content within a recognized regulatory framework referencing M4Q-R2, SPQS, and PQ-CMC advances relative to eCTD v4.0. Collaboration, and transformation envelops eCTD v4.0 and its far-reaching implications. Technology may be disruptive and revolutionary but must be introduced in a non-disruptive way to a highly regulated environment. Innovation within the CTD / eCTD v4.0 framework including cloud computing provides exactly this vehicle for change.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify eCTD 4.0 as a non-disruptive solution to data exchange
  • Evaluate updates about M4Q R2 and its relationship to eCTD 4.0 and plans for SPQS
  • Prepare for PQ-CMC and recognize its relevance to eCTD 4.0


David Sidney Ross, MBA, MSc, PMP, RAC

The Future of Regulatory Submissions Using eCTD 4.0 as a Non-disruptive Framework for Data Exchange

David Sidney Ross, MBA, MSc, PMP, RAC

AstraZeneca, United States

Senior Director, Regulatory Data and Submissions

Rodrigo  Palacios, MBA

The Future of CMC Submissions with ICH eCTD, M4Q R2, and SPQS

Rodrigo Palacios, MBA

F. Hoffmann-La Roche, Switzerland

Regulatory Policy Lead

Sarah  Pope Miksinski, PhD

Balancing Structured Data and Narrative for CMC

Sarah Pope Miksinski, PhD

Gilead Sciences, United States

Executive Director, CMC Regulatory Affairs

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