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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)
Frank Dickert
Senior Business Consultant, EXTEDO Gmbh, Germany
Enhancing Global Regulatory Collaboration: Implementing eCTD for WHO Submissions
Wim Dhaeze, PHD
Senior Director, Regulatory Operations, RIMS/DMS Lead, Sarepta Therapeutics, United States
Streamlined End-to-End Submission Management Using a State-of-the-Art Regulatory Information Management System
Allison Steffen
Submissions Lead, Regulatory Operations, WAYS Pharmaceutical Services, United States
Utilizing Grouped Submissions for Ad Promo
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