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Session 8 Track 1: Submission Standards and Efficiencies
Session Chair(s)
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
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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
Speaker(s)
Enhancing Global Regulatory Collaboration: Implementing eCTD for WHO Submissions
Frank Dickert
EXTEDO Gmbh, Germany
Senior Business Consultant
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
Utilizing Grouped Submissions for Ad Promo
Allison Steffen
WAYS Pharmaceutical Services, United States
Submissions Lead, Regulatory Operations