Session 8 Track 1: Submission Standards and Efficiencies
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
Enhancing Global Regulatory Collaboration: Implementing eCTD for WHO Submissions : Frank Dickert
Senior Business Consultant
EXTEDO Gmbh, Germany
Streamlined End-to-End Submission Management Using a State-of-the-Art Regulatory Information Management System: Wim Dhaeze, PhD
Senior Director, Global Regulatory Operations, RIMS/DMS Lead
Sarepta Therapeutics, Inc., United States
Utilizing Grouped Submissions for Ad Promo: Allison Steffen
Submissions Lead, Regulatory Operations
WAYS Pharmaceutical Services, United States
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