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Session 3 Track 2: Leveraging Submission, Document & Data Standards for Beneficial Organizational Impact
Session Chair(s)
Daniel Orfe, MS
President and CEO
Regulatory eSubmissions, LLC, United States
Learning Objective : Gain an understanding of inter-operable requirements for Regulatory Information Management (RIM) systems. Identify Requirements for interoperability of RIM systems. Identify some Gaps to be aware of when addressing In-Licensing, M&A, and automation of e-Submissions.
Speaker(s)
Stretching Standards to Cover eCTD InterOperability; Standard Gaps for InterOperability
Donald Palmer, MA
United States
Consultant
Changing the Drug Development Landscape: Impact of Electronic Data Standards on FDA Submissions and Preclinical Data Analysis
Laura Sue Kaufman, PhD
PDS Preclinical Data Systems, United States
Director, Preclinical Affairs
Facilitating Content Exchange Through the TMF Reference Model - Presentation of the New Initiative for an eTMF Exchange Standard from the TMF Reference Model
Paul Fenton, MBA
Montrium, Canada
CEO
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