Accelerating CMC Dossier Production with Structured Content Authoring and Live Data Connections

Join a 54-minute webinar exploring a next-generation, data-driven approach to generating CMC filings, presented by industry experts Ken Hayward and Kevin O'Leary. Learn how to move beyond conventional document-centric authoring to generate accurate, timely, and scalable CMC submissions directly from source data. Discover methods for automating current requirements while transitioning to new standards like FHIR for CMC creation. Through expert presentations and product demonstrations, explore key features including full data-driven content generation, source data traceability with refresh capability, content graph visibility for automated change control, and real-time collaborative editing in a SaaS environment. Gain valuable insights into addressing FDA initiatives such as KASA and understand how data-driven submissions can be implemented today. Benefit from the combined expertise of Ken Hayward, Director of Portfolio Management for Quality and Regulatory with 20+ years of experience, and Kevin O'Leary, an industry veteran with 29 years of executive management experience and current role as ENOVIA VP R&D.