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Session 4 Track 2: eSubmission Collaboration and Considerations for Cloud Solutions
Session Chair(s)
Hans van Bruggen, MSC
Director of Regulatory Affairs
Celegence, United States
Learning Objective : Defining your requirements for cloud-based eCTD publishing including constraints including budget, information technology systems and personnel, regulatory operations staffing, and the impact to your company's business model and exit strategy Determine how to make cloud-based eCTD publishing work for your company including critical auxiliary software, systems and interfaces needed for success
Speaker(s)
Soup to Nuts: A Recipe for eCTD Success and Cloud
Antoinette Azevedo
RegDocs365, United States
Co-Founder
Working in the Cloud: Leveraging a Cloud for DMS and Regulatory Submissions
Catherine Mazzrillo, MBA
Vertex Pharmaceuticals, United States
Associate Director, Regulatory Submission Management
Conducting Great Regulatory Operations in a Small Company Environment - Lessons Learned
Thomas Noto
Lexicon Pharmaceuticals, United States
Senior Director, Regulatory Operations