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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 8 Track 1: Submission Standards and Efficiencies

Session Chair(s)

Jillian E. Carinci, MS

Jillian E. Carinci, MS

Senior Director, Head of Submission Sciences

Biogen, United States

This session will explore three different models of submission standards and efficiencies:

  • A comprehensive overview of the WHO's eCTD implementation, highlighting its benefits, challenges, and impact on the global regulatory landscape.
  • How a well-designed Regulatory Information Management (RIM) System is critical to support effective document management processes and the streamlined compilation of regulatory submissions through dispatch.
  • Building a single sequence that can distribute documents to several different applications simultaneously in the US via Grouped Submissions utilizing Ad Promo as an example.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize common challenges face during eCTD adoption and react to WHO eCTD requirements
  • Practice effective and streamlined document management and apply fundamental principles of submission management to end-to-end process
  • Identify strategies and publishing approaches for preparing a promotional submission


Frank  Dickert

Enhancing Global Regulatory Collaboration: Implementing eCTD for WHO Submissions

Frank Dickert

EXTEDO Gmbh, Germany

Senior Business Consultant

Wim  Dhaeze, PhD

Streamlined End-to-End Submission Management Using a State-of-the-Art Regulatory Information Management System

Wim Dhaeze, PhD

Sarepta Therapeutics, Inc., United States

Senior Director, Global Regulatory Operations, RIMS/DMS Lead

Allison  Steffen

Utilizing Grouped Submissions for Ad Promo

Allison Steffen

WAYS Pharmaceutical Services, United States

Submissions Lead, Regulatory Operations

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