Director of Portfolio Management for Quality and Regulatory, Dassault Systèmes
BIOGRAPHY
November 27, 2:00pm GMT, 3:00pm CET
Accelerating CMC Dossier Production with Structured Content Authoring and Live Data Connections
Speakers
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Kevin O'Leary
Vice President Quality & Compliance, Dassault SystèmesBIOGRAPHY
Event Date & Time
Date: November 27, 2023
Time: 2:00pm GMT, 3:00pm CET
Abstract
In this webinar, we will present a next generation, data-driven approach to generating CMC filings. Moving beyond conventional document centric authoring we will show how to generate accurate, timely and scalable CMC submissions directly from your source data. You will see how to not only automate what is required today, but how to transition to new standards such as FHIR for CMC creation. This exciting session will include expert presentation and product demonstration to illustrate the full value, including:
- Full Data driven content generation
- Traceability back to Source data plus refresh capability
- Where Used – Content Graph for visibility and automated Change Contro
- Real Time Collaborative editing in a SaaS environment
This is a an opportunity to experience what the future of CMC generation will look like and gain an understanding of how FDA initiatives such as KASA can be addressed. We know that the future of Submissions is data driven, this seminar will demonstrate how that is possible today.
Webinars will be available for unlimited on-demand viewing after live event.
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